Strategies Using Off-Patent Antibiotics for Methicillin Resistant S. Aureus "STOP MRSA"

• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) (NIH)
• Overall Status: Completed
• CT.gov ID: NCT00729937
• Collaborator: (none)
• Enrollment: 2,265
• Locations: 5
• Arms: 3
• Duration (Months): 50
• Patients Per Site: 453
• Patients Per Site Per Month: 9.1

Study Details

Study Description

Brief Summary

The purpose of this study is to determine the optimal outpatient treatment strategy of uncomplicated skin and soft tissue infection (SSTI) in areas of the United States where the prevalence of Community-Acquired Methicillin-Resistant Staphylococcus (S.) aureus (CA-MRSA) is high. Infection with the S. aureus bacteria that is resistant to antibiotics is a cause of SSTIs. Three oral antibiotics will be tested for off patent treatment. Patients will receive Trimethoprim/Sulfamethoxazole (TMP/SMX), placebo (substance containing no medication), clindamycin, or cephalexin or some combination of these. The study population will include 2,235 volunteers, children 13 years of age and over and adults presenting to 5 large urban Emergency Departments. Therapy for acute uncomplicated SSTIs, including abscess, infected wound, and cellulitis will start on the day of enrollment. Participants may be involved in study related procedures for about 9 weeks.

Condition or Disease	Intervention/Treatment	Phase
Staphylococcal Infection	Drug: Cephalexin; Drug: Clindamycin; Other: Placebo; Drug: Trimethoprim-sulfamethoxazole	Phase 2/Phase 3

Detailed Description

Community-acquired methicillin-resistant Staphylococcus aureus (CA-MRSA) has recently emerged as a cause of skin and soft-tissue infection (SSTI). In the current era of increasing CA-MRSA infections, the outpatient management of SSTIs has not been well studied. This will be a clinical trial to evaluate oral off-patent antibiotics for outpatient treatment of patients with any of the 3 main types of acute uncomplicated SSTI, i.e., abscesses, infected wounds, and cellulitis. Upon enrollment, subjects will be stratified by type of infection, and then randomized to various treatments. Subjects with an acute uncomplicated cutaneous abscess receiving incision and drainage (I&D) will be treated with Trimethoprim/Sulfamethoxazole (TMP/SMX) or placebo to determine whether the addition of an antibiotic with activity against CA-MRSA is more clinically efficacious than I&D alone. Subjects with an acute wound infection will be treated with TMP/SMX or clindamycin to determine if clindamycin, an antibiotic with activity against CA-MRSA, methicillin-susceptible Staphylococcus aureus (MSSA), and streptococci is more clinically efficacious than TMP/SMX, an antibiotic with activity against CA-MRSA and MSSA. Subjects with acute cellulitis will be treated with cephalexin/TMP/SMX or cephalexin/placebo to determine if cephalexin/TMP/SMX is more clinically efficacious than cephalexin alone. The primary objectives for each type of SSTI studied are to compare the cure rates in the per protocol (PP) population. Secondary objectives provide additional means of assessment for the clinical efficacy of the employed interventions and resolution of the infection and include describing microbiological cure, change in the dimension of erythema, composite cure, surgical procedures, invasive and recurrent infections, infections in household contacts, and time to normal activity and until analgesics are no longer used at various times in the PP/ modified intent-to-treat (mITT) populations. This is a multi-center, randomized, double-blind clinical trial in which subjects will be stratified by the type of infection and then randomized to various 7-day oral antibiotic treatments, including placebo-controlled and comparative designs. The study population will include children 13 years of age and over and adults, who weigh greater than or equal to 40 kg presenting to 5 large urban emergency departments. Therapy will start on the day of enrollment. Subjects will be evaluated upon enrollment, at 2-3 days after enrollment (OTV), at 1-3 days after the end-of-therapy (EOT), at 7-14 days after the end-of-therapy (TOC), and at 6-8 weeks after the end-of-therapy (EFV).

Study Design

• Study Type: Interventional
• Actual Enrollment: 2265 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Strategies Using Off-Patent Antibiotics for Methicillin-Resistant Staphylococcus Aureus ("STOP MRSA") - A Phase IIB, Multi-Center, Randomized, Double-Blind Clinical Trial
• Study Start Date: Apr 1, 2009
• Actual Primary Completion Date: May 1, 2013
• Actual Study Completion Date: Jun 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: TMP/SMX vs. Placebo Subjects with an acute uncomplicated cutaneous abscess will be randomized to receive either Trimethoprim/Sulfamethoxazole (TMP/SMX) (4 single strength pills, 80 mg/400 mg each, twice per day) or 4 placebo pills (twice per day).	Other: Placebo; Placebo tablet administered orally.; Drug: Trimethoprim-sulfamethoxazole; 4 single strength Trimethoprim/Sulfamethoxazole (TMP/SMX), 80 mg/400 mg each, twice per day.
Experimental: TMP/SMX vs. Clindamycin Subjects with an acute uncomplicated wound infection will be randomized to receive Trimethoprim/Sulfamethoxazole (TMP/SMX) (4 single strength pills, 80 mg/400 mg each, twice per day, with alternating 1 identical placebo pill, twice per day) or clindamycin (300 mg, four times per day, with 3 placebo pills on alternating doses).	Drug: Clindamycin; 300 mg, four times per day.; Other: Placebo; Placebo tablet administered orally.; Drug: Trimethoprim-sulfamethoxazole; 4 single strength Trimethoprim/Sulfamethoxazole (TMP/SMX), 80 mg/400 mg each, twice per day.
Experimental: Cephalexin and TMP/SMX vs. Cephalexin Subjects with acute uncomplicated cellulitis will be randomized to receive cephalexin (500 mg, four times per day) and Trimethoprim/Sulfamethoxazole (TMP/SMX) (4 single strength pills, 80 mg/400 mg each, twice per day) or cephalexin (500 mg, four times per day) and placebo (4 pills, twice per day).	Drug: Cephalexin; 500 mg, four times per day.; Other: Placebo; Placebo tablet administered orally.; Drug: Trimethoprim-sulfamethoxazole; 4 single strength Trimethoprim/Sulfamethoxazole (TMP/SMX), 80 mg/400 mg each, twice per day.

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Clinical Cure as of the Test-of-Cure (TOC) Visit in the Per Protocol Population [Days 14-21]

   Clinical cure at TOC was defined as no failure on any previous visit up through the TOC, absence of fever, and resolution or minimal presence of all the following signs and symptoms from baseline based on clinician assessment of erythema, swelling, and tenderness. A participant would have been a clinical failure at the On Therapy (OTV) visit with presence of fever attributable to the infection being studied, increase in erythema by 25% or more, or worsening of both swelling and tenderness based on clinical assessment. A participant would have been a clinical failure at the End of Therapy (EOT) visit with presence of fever attributable to the infection being studied, increase or no improvement in erythema, or no improvement in either swelling or tenderness based on clinical assessment.

Secondary Outcome Measures

1. Number of Participants With Clinical Cure as of the TOC Visit in the Intent to Treat Population [Days 14-21]

   Clinical cure at TOC was defined as no failure on any previous visit up through the TOC, absence of fever, and resolution or minimal presence of all the following signs and symptoms from baseline based on clinician assessment of erythema, swelling, and tenderness. A participant would have been a clinical failure at the On Therapy (OTV) visit with presence of fever attributable to the infection being studied, increase in erythema by 25% or more, or worsening of both swelling and tenderness based on clinical assessment. A participant would have been a clinical failure at the End of Therapy (EOT) visit with presence of fever attributable to the infection being studied, increase or no improvement in erythema, or no improvement in either swelling or tenderness based on clinical assessment.

2. Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Per Protocol Population [Day 1 to Day 3-4]

   The area of erythema was measured in square centimeters at baseline and at the on-therapy visit. For each subject, the change in area was calculated as the area at on-therapy subtracted from the area at baseline. The change in area was then divided by the original area to determine the proportional change. Participants were then categorized by reductions in 5% intervals, with participants whose erythema did not change or increased categorized as no reduction.

3. Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Intent to Treat Population [Day 1 to Day 3-4]

   The area of erythema was measured in square centimeters at baseline and at the on-therapy visit. For each subject, the change in area was calculated as the area at on-therapy subtracted from the area at baseline. The change in area was then divided by the original area to determine the proportional change. Participants were then categorized by reductions in 5% intervals, with participants whose erythema did not change or increased categorized as no reduction.

4. Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Per Protocol Population [Day 1 to Day 8-10]

   The area of erythema was measured in square centimeters at baseline and at the end-of-therapy visit. For each subject, the change in area was calculated as the area at end-of-therapy subtracted from the area at baseline. The change in area was then divided by the original area to determine the proportional change. Participants were then categorized by reductions in 5% intervals, with participants whose erythema did not change or increased categorized as no reduction.

5. Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Intent to Treat Population [Day 1 to Day 8-10]

   The area of erythema was measured in square centimeters at baseline and at the end-of-therapy visit. For each subject, the change in area was calculated as the area at end-of-therapy subtracted from the area at baseline. The change in area was then divided by the original area to determine the proportional change. Participants were then categorized by reductions in 5% intervals, with participants whose erythema did not change or increased categorized as no reduction.

6. Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Per Protocol Population [Day 1 to Day 14-21]

   The area of erythema was measured in square centimeters at baseline and at the TOC visit. For each subject, the change in area was calculated as the area at TOC subtracted from the area at baseline. The change in area was then divided by the original area to determine the proportional change. Participants were then categorized by reductions in 5% intervals, with participants whose erythema did not change or increased categorized as no reduction.

7. Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Intent to Treat Population [Day 1 to Day 14-21]

   The area of erythema was measured in square centimeters at baseline and at the TOC visit. For each subject, the change in area was calculated as the area at TOC subtracted from the area at baseline. The change in area was then divided by the original area to determine the proportional change. Participants were then categorized by reductions in 5% intervals, with participants whose erythema did not change or increased categorized as no reduction.

8. Number of Participants by Composite Clinical Outcome at the TOC Visit in the Per Protocol Population [Day 14-21]

   Participants were categorized as composite clinical cure if they had resolution of all symptoms/signs of infection, or improvement to such an extent that no additional antibiotic therapy and/or surgical procedures were necessary. Participants were categorized as composite clinical failure if they had lack of resolution of all signs and symptoms of infection to such an extent that further antibiotic therapy and/or surgical procedures were necessary.

9. Number of Participants With Each Microbiological Outcome at the TOC Visit in the Per Protocol Population [Day 14-21]

   Participants were categorized for the microbiological outcome with Presumed eradication if they were not deemed a clinical failure through TOC. Those who were deemed a clinical failure through the TOC were classified as one of the following: Persistence=persistent growth of a pre-therapy pathogen; New infection=growth of a new pathogen and eradication of initial pathogen; Super-infection=growth of a new pathogen in addition to persistent growth of pre-therapy pathogen; Unclassified=no specimen for culture or growth of a pathogen in subsequent culture specimen of cellulitis participants, or for whom initial culture specimens were negative or were not obtained for infected wound and abscess participants; or Indeterminate=not meeting any one of the above microbiologic outcome criteria.

10. Number of Participants Requiring Surgical Intervention Through the TOC Visit in the Per Protocol Population [Day 1 through Day 14-21]

    All surgical procedures such as incision and drainage (I&D) and debridement that were related to the current infection under study or significant to the health of the subject, except for the initial I&D of an abscess for participants in the abscess or infected wound arms, were recorded. Participants who required a surgical intervention between the initial enrollment (excluding the initial I&D as applicable) and the test-of-cure visit are summarized.

11. Number of Participants Requiring Surgical Intervention Through the TOC Visit in the Intent to Treat Population [Day 1 through Day 14-21]

    All surgical procedures such as incision and drainage (I&D) and debridement that were related to the current infection under study or significant to the health of the subject, except for the initial I&D of an abscess for participants in the abscess or infected wound arms, were recorded. Participants who required a surgical intervention between the initial enrollment (excluding the initial I&D as applicable) and the test-of-cure visit are summarized.

12. Number of Participants Requiring Surgical Intervention Through the Extended Follow-up Visit (EFV) in the Per Protocol Population [Day 1 through Day 49-63]

    All surgical procedures such as incision and drainage (I&D) and debridement that were related to the current infection under study or significant to the health of the subject, except for the initial I&D of an abscess for participants in the abscess or infected wound arms, were recorded. Participants who required a surgical intervention between the initial enrollment (excluding the initial I&D as applicable) and the extended follow-up visit are summarized.

13. Number of Participants Requiring Surgical Intervention Through the Extended Follow-up Visit (EFV) in the Intent to Treat Population [Day 1 through Day 49-63]

    All surgical procedures such as incision and drainage (I&D) and debridement that were related to the current infection under study or significant to the health of the subject, except for the initial I&D of an abscess for participants in the abscess or infected wound arms, were recorded. Participants who required a surgical intervention between the initial enrollment (excluding the initial I&D as applicable) and the extended follow-up visit are summarized.

14. Number of Participants With Development of an Invasive Infection Through the TOC Visit in the Per Protocol Population [Day 1 through Day 14-21]

    Participants were evaluated for invasive infection, which included, but was not limited to, findings of severe sepsis/septic shock, endocarditis, pneumonia, necrotizing soft tissue, osteomyelitis, and bacteremia. A positive response to at least one finding was considered invasive infection for this outcome measure.

15. Number of Participants With Development of an Invasive Infection Through the TOC Visit in the Intent to Treat Population [Day 1 through Day 14-21]

    Participants were evaluated for invasive infection, which included, but was not limited to, findings of severe sepsis/septic shock, endocarditis, pneumonia, necrotizing soft tissue, osteomyelitis, and bacteremia. A positive response to at least one finding was considered invasive infection for this outcome measure.

16. Number of Participants With Development of an Invasive Infection Through the EFV Visit in the Per Protocol Population [Day 1 through Day 49-63]

    Participants were evaluated for invasive infection, which included, but was not limited to, findings of severe sepsis/septic shock, endocarditis, pneumonia, necrotizing soft tissue, osteomyelitis, and bacteremia. A positive response to at least one finding was considered invasive infection for this outcome measure.

17. Number of Participants With Development of an Invasive Infection Through the EFV Visit in the Intent to Treat Population [Day 1 through Day 49-63]

    Participants were evaluated for invasive infection, which included, but was not limited to, findings of severe sepsis/septic shock, endocarditis, pneumonia, necrotizing soft tissue, osteomyelitis, and bacteremia. A positive response to at least one finding was considered invasive infection for this outcome measure.

18. Number of Participants Who Developed a Recurrent Infection at the Original Infection Site Through the TOC Visit in the Per Protocol Population [Day 1 through Day 14-21]

    Participants were evaluated for the development of a recurrent, or repeat, infection at the original infection site. Participants who were reported to have developed a recurrent infection though the test-of-cure visit are summarized.

19. Number of Participants Who Developed a Recurrent Infection at the Original Infection Site Through the TOC Visit in the Intent to Treat Population [Day 1 through Day 14-21]

    Participants were evaluated for the development of a recurrent, or repeat, infection at the original infection site. Participants who were reported to have developed a recurrent infection though the test-of-cure visit are summarized.

20. Number of Participants Who Developed a Recurrent Infection at the Original Infection Site Through the EFV Visit in the Per Protocol Population [Day 1 through Day 49-63]

    Participants were evaluated for the development of a recurrent, or repeat, infection at the original infection site. Participants who were reported to have developed a recurrent infection though the extended follow-up visit are summarized.

21. Number of Participants Who Developed a Recurrent Infection at the Original Infection Site Through the EFV Visit in the Intent to Treat Population [Day 1 through Day 49-63]

    Participants were evaluated for the development of a recurrent, or repeat, infection at the original infection site. Participants who were reported to have developed a recurrent infection though the extended follow-up visit are summarized.

22. Number of Participants With Infections in Household Contacts Through the TOC Visit in the Per Protocol Population [Day 1 through Day 14-21]

    At each follow-up visit, participants were asked about history of skin infections in household members (e.g., similar skin infection in a family member). This outcome measure relied solely on participant reporting. Participants who reported having a family member with a similar infection though the test-of-cure visit are summarized.

23. Number of Participants With Infections in Household Contacts Through the TOC Visit in the Intent to Treat Population [Day 1 through Day 14-21]

    At each follow-up visit, participants were asked about history of skin infections in household members (e.g., similar skin infection in a family member). This outcome measure relied solely on participant reporting. Participants who reported having a family member with a similar infection though the test-of-cure visit are summarized.

24. Number of Participants With Infections in Household Contacts Through the EFV Visit in the Per Protocol Population [Day 1 through Day 49-63]

    At each follow-up visit, participants were asked about history of skin infections in household members (e.g., similar skin infection in a family member). This outcome measure relied solely on participant reporting. Participants who reported having a family member with a similar infection though the extended follow-up visit are summarized.

25. Number of Participants With Infections in Household Contacts Through the EFV Visit in the Intent to Treat Population [Day 1 through Day 49-63]

    At each follow-up visit, participants were asked about history of skin infections in household members (e.g., similar skin infection in a family member). This outcome measure relied solely on participant reporting. Participants who reported having a family member with a similar infection though the extended follow-up visit are summarized.

26. Number of Participants With Adverse Events Considered Associated With the Study Product by MedDRA System Organ Class [Day 1 through Day 49-63]

    All adverse events were recorded through the test of cure visit; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit. All AEs were assessed for association with the study product by a clinician and were considered associated with study product if the event was temporally related to the administration of the study product and no other etiology more likely explains the event. Associated adverse events are summarized by MedDRA System Organ Class.

27. Mean Days Missed From Normal Activities in the Per Protocol Population [Day 1 through 14]

    As a quality of life measure, participants maintained a memory aid from Day 1 to Day 14 to track measures such as participation in normal life activities. The maximum number of days assessed, 14, was assigned to participants who had not yet resumed normal activities by the end of the assessment period.

28. Mean Days Missed From Normal Activities in the Intent to Treat Population [Day 1 through 14]

    As a quality of life measure, participants maintained a memory aid from Day 1 to Day 14 to track measures such as participation in normal life activities. The maximum number of days assessed, 14, was assigned to participants who had not yet resumed normal activities by the end of the assessment period.

29. Number of Participants Reporting 1-14 Days of Analgesic Use in the Per Protocol Population [Day 1 through 14]

    As a quality of life measure, participants maintained a memory aid from Day 1 to Day 14 to track measures such as use of other, non-study medications such as analgesics. Each participant is summarized by the last day of reported analgesic usage, from the start of treatment with study intervention. The maximum number of days assessed, 14, was assigned to participants who were still taking analgesic medications by the end of the assessment period.

30. Number of Participants Reporting 1-14 Days of Analgesic Use in the Intent to Treat Population [Day 1 through 14]

    As a quality of life measure, participants maintained a memory aid from Day 1 to Day 14 to track measures such as use of other, non-study medications such as analgesics. Each participant is summarized by the last day of reported analgesic usage, from the start of treatment with study intervention. The maximum number of days assessed, 14, was assigned to participants who were still taking analgesic medications by the end of the assessment period.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 13 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Adult or child 13 years of age and older (who weighs greater than or equal to 40 kg);

• Have a skin and soft tissue infection (SSTI) with all three local findings of erythema (> 2 cm across the lesion or from a discrete wound edge), tenderness, and swelling/induration. Fever, leukocytosis, and lymphangitis will be noted, but are not enrollment criteria. SSTI with these local findings will be further categorized and defined as one of:

1. Abscess - a fluctuant and/or indurated lesion, or findings of a fluid-filled cavity on soft tissue ultrasound evaluation that, when opened reveals purulent material, receiving incision and drainage (I&D) (considered standard care for abscess) and having a minimum diameter (along any axis) of at least 2 cm (measured from the borders of induration, if a fluctuant lesion, or borders of the abscess cavity on ultrasound, if not fluctuant).

Note: Although I&D of an abscess is considered standard care (i.e., patients will receive I&D whether or not they are enrolled in the study), the procedure may be performed after enrollment into the study so that prior measurements of the area of erythema and swelling/induration can be obtained unless it is an occult abscess in which the I&D will be performed prior to enrollment to verify infection type and ensure correct classification of the subject.

1. Infected Wound - a wound (defined as any apparent break in the skin) with any apparent drainage limited in depth to only involving skin and subcutaneous tissue, including sutured cutaneous wounds not involving intra-abdominal surgeries contaminated with bacterial or bowel contents (e.g., colon surgery and empyema drainage), and

2. Cellulitis - an area of erythema without the presence of a wound with drainage or abscess; Cellulitis associated with an abscess will be categorized as an abscess. Cellulitis associated with an infected wound will be classified as an infected wound. Patients with cellulitis and an abscess less than 2 cm will be excluded. Infected wound associated with an abscess that may require I&D, will be classified as an infected wound.

• Have the infected lesion for 7 days or less duration;

• Are to receive outpatient treatment at enrollment/baseline;

• Express willingness and ability to be contacted and return for re-evaluation according to the study protocol;

• Provide written informed consent (and for subjects ages 13-17, consent from their guardian and assent);

• Negative pregnancy test for subjects who are women of childbearing potential.

Exclusion Criteria:

• Severe allergy or reaction to study drug or drugs similar to the study drug relevant to whichever study sub-trial the subject would be assigned to (e.g., patients with severe or life-threatening penicillin allergies, allergy to any cephalosporin, clindamycin, or sulfonamides, or any other drug containing sulfur such as thiazides, furosemide, and oral sulfonylureas);

• Concomitant treatment (i.e., while on study drug therapy) with coumadin, phenytoin, or methotrexate, or suspected G-6-PD or folic acid deficiency;

• Expected inability to swallow or absorb the study drug (assessed by patient history);

• Pregnancy, nursing, or expectation of becoming pregnant while on study drug;

• Perirectal (within 5 cm of anus), perineal non-skin lesions (i.e., mucosal), or paronychial location of infection. Scrotal and labial abscesses will not be excluded.

• An infection due to a mammalian bite;

• Treatment with a study drug relevant to their infection type, or another systemic antibiotic in the previous 48 hours (i.e., before screening/baseline) unless associated with treatment failure which is defined as a patient who has been on prior (non study drug) antibiotics for at least 72 hours and failed.

• Expected concurrent treatment with a topical antibiotic or another systemic antibiotic up to Test-of-Cure Visit (TOC) (note: if patient was using a topical antibiotic previously, they can still be enrolled if they agree to stop using it);

• Immunodeficiency [e.g., absolute neutrophil count <500/mm^3, chronic immunosuppressive drugs, active chemotherapy, or known acquired immunodeficiency syndrome (AIDS) (CD4 count <200 or AIDS-defining illness within the last year) assessed by patient history]. Note: patients who had prior AIDS-defining illness or CD4 count <200 in the past may be enrolled if most recent CD4 count >200;

• Burn or active chronic skin condition (e.g., including rash or eczema) related to the skin and soft-tissue infection (SSTI) at screening/baseline;

• Infection related to currently indwelling device (e.g., intravenous line), excepting sutures associated with qualifying infected wounds which will be removed upon enrollment;

• Infection for which prior cultures reveal in vitro resistance of a pathogen to a study drug in the previous month prior to screening/baseline;

• Known or suspected osteomyelitis or septic arthritis;

• Infection related to diabetic foot, decubitus, or ischemic ulcer;

• Known severe renal insufficiency (creatinine clearance < 50 mL/min) calculated by measurement of serum creatinine if patient provides this history or based on past studies at baseline/enrollment;

• Prior enrollment in this study within 12 weeks;

• Another active infection of another organ system (e.g., pneumonia) or more than one active (i.e., currently on antibiotic treatment and/or requiring I&D) SSTI site (e.g., a site noncontiguous with the infection under study). Note: Minor folliculitis at secondary site is not an exclusion;

• Presence of an abscess that has completely drained, either spontaneously or by a healthcare provider prior to enrollment;

• An infected wound or cellulitis that has been surgically explored (>1 cm incision) and does not reveal an abscess. Cellulitis that has been needled, minimally incised (less than or equal to 1 cm) or punch biopsied and no purulent drainage found can still be enrolled;

• Currently incarcerated in a detention facility or in police custody (note: patients wearing a monitoring device can be enrolled) at baseline/screening;

• For patients with an infected wound, history of C. difficile infection, pseudomembranous colitis, or active diarrhea at baseline/screening;

• For patients with an infected wound, severe liver disease based on patient history;

• An intravenous (IV) drug user in the last month with current presence of fever;

• Current residence in a nursing home or other long term care facility at baseline/screening;

• Expected use of other investigational drug or vaccine while on study drug;

• For patients with an abscess, cardiac conditions associated with the highest risk of adverse outcome from endocarditis for which prophylaxis is reasonable, including patients with prosthetic cardiac valve or prosthetic material used for cardiac valve repair, history of previous infective endocarditis, congenital heart disease (excluding mitral valve prolapse), and history of cardiac transplantation recipients who develop cardiac valvulopathy;

• Presence of an organic foreign body, e.g., wood (note: subjects with embedded non-organic materials, e.g., metal or glass, that can be completely removed can still be enrolled if physician is certain there is no foreign body left).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Maricopa Medical Center - Emergency Medicine	Phoenix	Arizona	United States	85008-4973
2	University of California Los Angeles - Olive View Medical Center	Sylmar	California	United States	91342-1437
3	Johns Hopkins University at Mount Washington - Emergency Medicine	Baltimore	Maryland	United States	21209-3652
4	Truman Medical Center - Hospital Hill	Kansas City	Missouri	United States	64108-2640
5	Temple University Hospital	Philadelphia	Pennsylvania	United States	19140-5103

Sponsors and Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
• ClinicalTrials.gov Identifier: NCT00729937
• Other Study ID Numbers: 07-0040
• First Posted: Aug 8, 2008
• Last Update Posted: Feb 18, 2015
• Last Verified: Sep 1, 2013

• Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID): Methicillin, Staphylococcus aureus, MRSA
• Additional relevant MeSH terms: Staphylococcal Infections; Clindamycin; Clindamycin palmitate; Clindamycin phosphate; Cephalexin; Trimethoprim, Sulfamethoxazole Drug Combination; Trimethoprim; Sulfamethoxazole

Study Results

Participant Flow

Recruitment Details	Participants were recruited between 13APR2009 and 16APR2013 from those who presented with an abscess, infected wound, or cellulitis at emergency departments at each of the clinical sites.

Arm/Group Title	Abscess, Placebo	Abscess, TMP/SMX	Infected Wound, TMP/SMX	Infected Wound, Clindamycin	Cellulitis, Cephalexin and TMP/SMX	Cellulitis, Cephalexin
Arm/Group Description	Participants with an acute uncomplicated cutaneous abscess received 4 placebo pills twice per day.	Participants with an acute uncomplicated cutaneous abscess received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.	Participants with an acute uncomplicated wound infection received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day, with alternating 1 identical placebo pill, twice per day.	Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses.	Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.	Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day.
Period Title: Overall Study
STARTED	629	636	251	249	249	251
COMPLETED	555	548	222	215	221	214
NOT COMPLETED	74	88	29	34	28	37

Baseline Characteristics

Arm/Group Title	Abscess, Placebo	Abscess, TMP/SMX	Infected Wound, TMP/SMX	Infected Wound, Clindamycin	Cellulitis, Cephalexin and TMP/SMX	Cellulitis, Cephalexin	Total
Arm/Group Description	Participants with an acute uncomplicated cutaneous abscess received 4 placebo pills twice per day.	Participants with an acute uncomplicated cutaneous abscess received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.	Participants with an acute uncomplicated wound infection received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day, with alternating 1 identical placebo pill, twice per day.	Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses.	Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.	Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day.	Total of all reporting groups
Overall Participants	533	524	198	203	218	193	1869
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	36.8 (12.3)	37.0 (12.6)	40.4 (13.1)	38.0 (13.3)	39.7 (13.3)	39.4 (13.2)	38.0 (12.9)
Age (Count of Participants)
<=18 years	17 3.2%	10 1.9%	3 1.5%	5 2.5%	3 1.4%	2 1%	40 2.1%
Between 18 and 65 years	513 96.2%	511 97.5%	191 96.5%	195 96.1%	206 94.5%	187 96.9%	1803 96.5%
>=65 years	3 0.6%	3 0.6%	4 2%	3 1.5%	9 4.1%	4 2.1%	26 1.4%
Sex: Female, Male (Count of Participants)
Female	225 42.2%	221 42.2%	65 32.8%	81 39.9%	81 37.2%	90 46.6%	763 40.8%
Male	308 57.8%	303 57.8%	133 67.2%	122 60.1%	137 62.8%	103 53.4%	1106 59.2%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	2 0.4%	3 0.6%	0 0%	2 1%	2 0.9%	0 0%	9 0.5%
Asian	2 0.4%	5 1%	0 0%	0 0%	2 0.9%	2 1%	11 0.6%
Native Hawaiian or Other Pacific Islander	1 0.2%	0 0%	0 0%	0 0%	0 0%	0 0%	1 0.1%
Black or African American	233 43.7%	232 44.3%	71 35.9%	73 36%	75 34.4%	68 35.2%	752 40.2%
White	252 47.3%	244 46.6%	115 58.1%	117 57.6%	123 56.4%	111 57.5%	962 51.5%
More than one race	22 4.1%	22 4.2%	7 3.5%	3 1.5%	7 3.2%	8 4.1%	69 3.7%
Unknown or Not Reported	21 3.9%	18 3.4%	5 2.5%	8 3.9%	9 4.1%	4 2.1%	65 3.5%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	180 33.8%	178 34%	63 31.8%	72 35.5%	75 34.4%	60 31.1%	628 33.6%
Not Hispanic or Latino	353 66.2%	346 66%	134 67.7%	131 64.5%	143 65.6%	133 68.9%	1240 66.3%
Unknown or Not Reported	0 0%	0 0%	1 0.5%	0 0%	0 0%	0 0%	1 0.1%
Region of Enrollment (participants) [Number]
United States	533 100%	524 100%	198 100%	203 100%	218 100%	193 100%	1869 100%

Outcome Measures

1. Secondary Outcome

Title	Number of Participants With Clinical Cure as of the TOC Visit in the Intent to Treat Population
Description	Clinical cure at TOC was defined as no failure on any previous visit up through the TOC, absence of fever, and resolution or minimal presence of all the following signs and symptoms from baseline based on clinician assessment of erythema, swelling, and tenderness. A participant would have been a clinical failure at the On Therapy (OTV) visit with presence of fever attributable to the infection being studied, increase in erythema by 25% or more, or worsening of both swelling and tenderness based on clinical assessment. A participant would have been a clinical failure at the End of Therapy (EOT) visit with presence of fever attributable to the infection being studied, increase or no improvement in erythema, or no improvement in either swelling or tenderness based on clinical assessment.
Time Frame	Days 14-21

Outcome Measure Data

Analysis Population Description

All subjects who took at least one dose of study medication were included in the intent to treat population.

Arm/Group Title	Abscess, Placebo	Abscess, TMP/SMX	Infected Wound, TMP/SMX	Infected Wound, Clindamycin	Cellulitis, Cephalexin and TMP/SMX	Cellulitis, Cephalexin
Arm/Group Description	Participants with an acute uncomplicated cutaneous abscess received 4 placebo pills twice per day.	Participants with an acute uncomplicated cutaneous abscess received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.	Participants with an acute uncomplicated wound infection received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day, with alternating 1 identical placebo pill, twice per day.	Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses.	Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.	Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day.
Measure Participants	617	630	250	249	248	248
Clinical Cure	454 85.2%	507 96.8%	197 99.5%	198 97.5%	189 86.7%	171 88.6%
Clinical Failure	163 30.6%	123 23.5%	53 26.8%	51 25.1%	59 27.1%	77 39.9%

2. Primary Outcome

Title	Number of Participants With Clinical Cure as of the Test-of-Cure (TOC) Visit in the Per Protocol Population
Description	Clinical cure at TOC was defined as no failure on any previous visit up through the TOC, absence of fever, and resolution or minimal presence of all the following signs and symptoms from baseline based on clinician assessment of erythema, swelling, and tenderness. A participant would have been a clinical failure at the On Therapy (OTV) visit with presence of fever attributable to the infection being studied, increase in erythema by 25% or more, or worsening of both swelling and tenderness based on clinical assessment. A participant would have been a clinical failure at the End of Therapy (EOT) visit with presence of fever attributable to the infection being studied, increase or no improvement in erythema, or no improvement in either swelling or tenderness based on clinical assessment.
Time Frame	Days 14-21

Outcome Measure Data

Analysis Population Description

The analysis population is the per protocol population. All participants who met enrollment criteria, had none of the exclusion criteria, completed at least 75% of the first 5 days of antimicrobial therapy, and had physical follow-up at the Test of Cure (TOC) visit were included in the per protocol population.

Arm/Group Title	Abscess, Placebo	Abscess, TMP/SMX	Infected Wound, TMP/SMX	Infected Wound, Clindamycin	Cellulitis, Cephalexin and TMP/SMX	Cellulitis, Cephalexin
Arm/Group Description	Participants with an acute uncomplicated cutaneous abscess received 4 placebo pills twice per day.	Participants with an acute uncomplicated cutaneous abscess received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.	Participants with an acute uncomplicated wound infection received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day, with alternating 1 identical placebo pill, twice per day.	Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses.	Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.	Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day.
Measure Participants	533	524	198	203	218	193
Clinical Cure	457 85.7%	487 92.9%	182 91.9%	187 92.1%	182 83.5%	165 85.5%
Clinical Failure	76 14.3%	37 7.1%	16 8.1%	16 7.9%	36 16.5%	28 14.5%

3. Secondary Outcome

Title	Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Per Protocol Population
Description	The area of erythema was measured in square centimeters at baseline and at the on-therapy visit. For each subject, the change in area was calculated as the area at on-therapy subtracted from the area at baseline. The change in area was then divided by the original area to determine the proportional change. Participants were then categorized by reductions in 5% intervals, with participants whose erythema did not change or increased categorized as no reduction.
Time Frame	Day 1 to Day 3-4

Outcome Measure Data

Analysis Population Description

The analysis population is the per protocol population. All participants who met enrollment criteria, had none of the exclusion criteria, completed at least 75% of the first 5 days of antimicrobial therapy, and had physical follow-up at the Test of Cure (TOC) visit were included in the per protocol population.

Arm/Group Title	Abscess, Placebo	Abscess, TMP/SMX	Infected Wound, TMP/SMX	Infected Wound, Clindamycin	Cellulitis, Cephalexin and TMP/SMX	Cellulitis, Cephalexin
Arm/Group Description	Participants with an acute uncomplicated cutaneous abscess received 4 placebo pills twice per day.	Participants with an acute uncomplicated cutaneous abscess received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.	Participants with an acute uncomplicated wound infection received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day, with alternating 1 identical placebo pill, twice per day.	Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses.	Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.	Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day.
Measure Participants	533	523	195	203	217	192
No reduction	59 11.1%	37 7.1%	11 5.6%	17 8.4%	30 13.8%	33 17.1%
>0%-5% reduction	3 0.6%	2 0.4%	1 0.5%	1 0.5%	1 0.5%	2 1%
>5%-10% reduction	1 0.2%	4 0.8%	3 1.5%	0 0%	5 2.3%	1 0.5%
>10%-15% reduction	3 0.6%	3 0.6%	1 0.5%	3 1.5%	5 2.3%	0 0%
>15%-20% reduction	2 0.4%	6 1.1%	4 2%	5 2.5%	3 1.4%	2 1%
>20%-25% reduction	6 1.1%	3 0.6%	5 2.5%	2 1%	4 1.8%	4 2.1%
>25%-30% reduction	11 2.1%	6 1.1%	5 2.5%	3 1.5%	5 2.3%	3 1.6%
>30%-35% reduction	13 2.4%	7 1.3%	4 2%	5 2.5%	2 0.9%	7 3.6%
>35%-40% reduction	12 2.3%	13 2.5%	3 1.5%	3 1.5%	6 2.8%	2 1%
>40%-45% reduction	16 3%	15 2.9%	7 3.5%	6 3%	8 3.7%	6 3.1%
>45%-50% reduction	12 2.3%	12 2.3%	5 2.5%	6 3%	5 2.3%	9 4.7%
>50%-55% reduction	13 2.4%	6 1.1%	6 3%	6 3%	4 1.8%	6 3.1%
>55%-60% reduction	10 1.9%	10 1.9%	4 2%	2 1%	9 4.1%	8 4.1%
>60%-65% reduction	14 2.6%	21 4%	12 6.1%	6 3%	15 6.9%	3 1.6%
>65%-70% reduction	19 3.6%	9 1.7%	6 3%	5 2.5%	7 3.2%	7 3.6%
>70%-75% reduction	14 2.6%	17 3.2%	8 4%	7 3.4%	9 4.1%	5 2.6%
>75%-80% reduction	13 2.4%	21 4%	6 3%	16 7.9%	8 3.7%	7 3.6%
>80%-85% reduction	19 3.6%	18 3.4%	8 4%	3 1.5%	10 4.6%	6 3.1%
>85%-90% reduction	18 3.4%	13 2.5%	4 2%	8 3.9%	5 2.3%	8 4.1%
>90%-95% reduction	13 2.4%	16 3.1%	5 2.5%	10 4.9%	5 2.3%	6 3.1%
>95%-100% reduction	262 49.2%	284 54.2%	87 43.9%	89 43.8%	71 32.6%	67 34.7%

4. Secondary Outcome

Title	Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Intent to Treat Population
Description	The area of erythema was measured in square centimeters at baseline and at the on-therapy visit. For each subject, the change in area was calculated as the area at on-therapy subtracted from the area at baseline. The change in area was then divided by the original area to determine the proportional change. Participants were then categorized by reductions in 5% intervals, with participants whose erythema did not change or increased categorized as no reduction.
Time Frame	Day 1 to Day 3-4

Outcome Measure Data

Analysis Population Description

All subjects who took at least one dose of study medication were included in the intent to treat population.

Arm/Group Title	Abscess, Placebo	Abscess, TMP/SMX	Infected Wound, TMP/SMX	Infected Wound, Clindamycin	Cellulitis, Cephalexin and TMP/SMX	Cellulitis, Cephalexin
Arm/Group Description	Participants with an acute uncomplicated cutaneous abscess received 4 placebo pills twice per day.	Participants with an acute uncomplicated cutaneous abscess received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.	Participants with an acute uncomplicated wound infection received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day, with alternating 1 identical placebo pill, twice per day.	Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses.	Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.	Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day.
Measure Participants	604	599	237	241	237	230
No reduction	67 12.6%	43 8.2%	12 6.1%	18 8.9%	34 15.6%	41 21.2%
>0%-5% reduction	3 0.6%	2 0.4%	1 0.5%	1 0.5%	1 0.5%	2 1%
>5%-10% reduction	2 0.4%	4 0.8%	3 1.5%	1 0.5%	6 2.8%	1 0.5%
>10%-15% reduction	3 0.6%	3 0.6%	1 0.5%	4 2%	5 2.3%	0 0%
>15%-20% reduction	2 0.4%	7 1.3%	4 2%	5 2.5%	5 2.3%	2 1%
>20%-25% reduction	7 1.3%	5 1%	6 3%	3 1.5%	4 1.8%	5 2.6%
>25%-30% reduction	12 2.3%	6 1.1%	5 2.5%	4 2%	5 2.3%	3 1.6%
>30%-35% reduction	13 2.4%	8 1.5%	5 2.5%	6 3%	4 1.8%	7 3.6%
>35%-40% reduction	12 2.3%	15 2.9%	3 1.5%	4 2%	6 2.8%	6 3.1%
>40%-45% reduction	20 3.8%	17 3.2%	8 4%	7 3.4%	9 4.1%	6 3.1%
>45%-50% reduction	13 2.4%	15 2.9%	6 3%	6 3%	5 2.3%	10 5.2%
>50%-55% reduction	14 2.6%	7 1.3%	7 3.5%	8 3.9%	4 1.8%	9 4.7%
>55%-60% reduction	12 2.3%	11 2.1%	4 2%	2 1%	9 4.1%	8 4.1%
>60%-65% reduction	15 2.8%	24 4.6%	12 6.1%	7 3.4%	16 7.3%	4 2.1%
>65%-70% reduction	21 3.9%	10 1.9%	7 3.5%	6 3%	7 3.2%	9 4.7%
>70%-75% reduction	18 3.4%	20 3.8%	10 5.1%	9 4.4%	11 5%	6 3.1%
>75%-80% reduction	17 3.2%	22 4.2%	11 5.6%	17 8.4%	9 4.1%	8 4.1%
>80%-85% reduction	20 3.8%	20 3.8%	9 4.5%	3 1.5%	11 5%	6 3.1%
>85%-90% reduction	20 3.8%	16 3.1%	5 2.5%	11 5.4%	6 2.8%	9 4.7%
>90%-95% reduction	15 2.8%	16 3.1%	7 3.5%	11 5.4%	6 2.8%	8 4.1%
>95%-100% reduction	298 55.9%	328 62.6%	111 56.1%	108 53.2%	74 33.9%	80 41.5%

5. Secondary Outcome

Title	Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Per Protocol Population
Description	The area of erythema was measured in square centimeters at baseline and at the end-of-therapy visit. For each subject, the change in area was calculated as the area at end-of-therapy subtracted from the area at baseline. The change in area was then divided by the original area to determine the proportional change. Participants were then categorized by reductions in 5% intervals, with participants whose erythema did not change or increased categorized as no reduction.
Time Frame	Day 1 to Day 8-10

Outcome Measure Data

Analysis Population Description

The analysis population is the per protocol population. All participants who met enrollment criteria, had none of the exclusion criteria, completed at least 75% of the first 5 days of antimicrobial therapy, and had physical follow-up at the Test of Cure (TOC) visit were included in the per protocol population.

Arm/Group Title	Abscess, Placebo	Abscess, TMP/SMX	Infected Wound, TMP/SMX	Infected Wound, Clindamycin	Cellulitis, Cephalexin and TMP/SMX	Cellulitis, Cephalexin
Arm/Group Description	Participants with an acute uncomplicated cutaneous abscess received 4 placebo pills twice per day.	Participants with an acute uncomplicated cutaneous abscess received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.	Participants with an acute uncomplicated wound infection received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day, with alternating 1 identical placebo pill, twice per day.	Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses.	Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.	Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day.
Measure Participants	527	520	193	200	212	190
No reduction	4 0.8%	3 0.6%	3 1.5%	3 1.5%	5 2.3%	5 2.6%
>0%-5% reduction	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
>5%-10% reduction	1 0.2%	0 0%	0 0%	0 0%	1 0.5%	0 0%
>10%-15% reduction	0 0%	1 0.2%	1 0.5%	0 0%	0 0%	0 0%
>15%-20% reduction	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
>20%-25% reduction	0 0%	0 0%	0 0%	0 0%	1 0.5%	0 0%
>25%-30% reduction	2 0.4%	1 0.2%	1 0.5%	0 0%	0 0%	1 0.5%
>30%-35% reduction	0 0%	1 0.2%	0 0%	0 0%	1 0.5%	1 0.5%
>35%-40% reduction	2 0.4%	1 0.2%	0 0%	0 0%	1 0.5%	0 0%
>40%-45% reduction	0 0%	3 0.6%	2 1%	0 0%	0 0%	1 0.5%
>45%-50% reduction	2 0.4%	0 0%	1 0.5%	1 0.5%	0 0%	0 0%
>50%-55% reduction	4 0.8%	1 0.2%	2 1%	1 0.5%	0 0%	2 1%
>55%-60% reduction	0 0%	5 1%	1 0.5%	1 0.5%	1 0.5%	2 1%
>60%-65% reduction	1 0.2%	0 0%	3 1.5%	2 1%	5 2.3%	1 0.5%
>65%-70% reduction	4 0.8%	3 0.6%	2 1%	1 0.5%	2 0.9%	2 1%
>70%-75% reduction	3 0.6%	2 0.4%	3 1.5%	0 0%	5 2.3%	2 1%
>75%-80% reduction	6 1.1%	2 0.4%	2 1%	1 0.5%	2 0.9%	2 1%
>80%-85% reduction	4 0.8%	5 1%	1 0.5%	3 1.5%	0 0%	1 0.5%
>85%-90% reduction	7 1.3%	7 1.3%	1 0.5%	4 2%	4 1.8%	4 2.1%
>90%-95% reduction	9 1.7%	7 1.3%	3 1.5%	1 0.5%	1 0.5%	4 2.1%
>95%-100% reduction	478 89.7%	478 91.2%	167 84.3%	182 89.7%	183 83.9%	162 83.9%

6. Secondary Outcome

Title	Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Intent to Treat Population
Description	The area of erythema was measured in square centimeters at baseline and at the end-of-therapy visit. For each subject, the change in area was calculated as the area at end-of-therapy subtracted from the area at baseline. The change in area was then divided by the original area to determine the proportional change. Participants were then categorized by reductions in 5% intervals, with participants whose erythema did not change or increased categorized as no reduction.
Time Frame	Day 1 to Day 8-10

Outcome Measure Data

Analysis Population Description

All subjects who took at least one dose of study medication were included in the intent to treat population.

Arm/Group Title	Abscess, Placebo	Abscess, TMP/SMX	Infected Wound, TMP/SMX	Infected Wound, Clindamycin	Cellulitis, Cephalexin and TMP/SMX	Cellulitis, Cephalexin
Arm/Group Description	Participants with an acute uncomplicated cutaneous abscess received 4 placebo pills twice per day.	Participants with an acute uncomplicated cutaneous abscess received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.	Participants with an acute uncomplicated wound infection received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day, with alternating 1 identical placebo pill, twice per day.	Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses.	Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.	Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day.
Measure Participants	582	576	228	231	229	225
No reduction	5 0.9%	3 0.6%	3 1.5%	3 1.5%	5 2.3%	5 2.6%
>0%-5% reduction	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
>5%-10% reduction	1 0.2%	0 0%	0 0%	0 0%	1 0.5%	0 0%
>10%-15% reduction	0 0%	1 0.2%	1 0.5%	1 0.5%	0 0%	1 0.5%
>15%-20% reduction	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
>20%-25% reduction	0 0%	0 0%	1 0.5%	0 0%	1 0.5%	0 0%
>25%-30% reduction	2 0.4%	1 0.2%	1 0.5%	0 0%	0 0%	1 0.5%
>30%-35% reduction	0 0%	1 0.2%	0 0%	0 0%	1 0.5%	1 0.5%
>35%-40% reduction	2 0.4%	1 0.2%	0 0%	0 0%	1 0.5%	0 0%
>40%-45% reduction	0 0%	3 0.6%	3 1.5%	0 0%	0 0%	1 0.5%
>45%-50% reduction	2 0.4%	0 0%	1 0.5%	1 0.5%	0 0%	0 0%
>50%-55% reduction	4 0.8%	1 0.2%	2 1%	1 0.5%	0 0%	2 1%
>55%-60% reduction	0 0%	5 1%	1 0.5%	1 0.5%	1 0.5%	2 1%
>60%-65% reduction	2 0.4%	0 0%	3 1.5%	2 1%	5 2.3%	2 1%
>65%-70% reduction	4 0.8%	3 0.6%	2 1%	1 0.5%	2 0.9%	3 1.6%
>70%-75% reduction	3 0.6%	2 0.4%	3 1.5%	2 1%	5 2.3%	2 1%
>75%-80% reduction	6 1.1%	2 0.4%	2 1%	1 0.5%	3 1.4%	2 1%
>80%-85% reduction	4 0.8%	5 1%	1 0.5%	4 2%	0 0%	2 1%
>85%-90% reduction	7 1.3%	9 1.7%	2 1%	4 2%	4 1.8%	6 3.1%
>90%-95% reduction	9 1.7%	7 1.3%	5 2.5%	2 1%	2 0.9%	7 3.6%
>95%-100% reduction	531 99.6%	532 101.5%	197 99.5%	208 102.5%	198 90.8%	188 97.4%

7. Secondary Outcome

Title	Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Per Protocol Population
Description	The area of erythema was measured in square centimeters at baseline and at the TOC visit. For each subject, the change in area was calculated as the area at TOC subtracted from the area at baseline. The change in area was then divided by the original area to determine the proportional change. Participants were then categorized by reductions in 5% intervals, with participants whose erythema did not change or increased categorized as no reduction.
Time Frame	Day 1 to Day 14-21

Outcome Measure Data

Analysis Population Description

The analysis population is the per protocol population. All participants who met enrollment criteria, had none of the exclusion criteria, completed at least 75% of the first 5 days of antimicrobial therapy, and had physical follow-up at the Test of Cure (TOC) visit were included in the per protocol population.

Arm/Group Title	Abscess, Placebo	Abscess, TMP/SMX	Infected Wound, TMP/SMX	Infected Wound, Clindamycin	Cellulitis, Cephalexin and TMP/SMX	Cellulitis, Cephalexin
Arm/Group Description	Participants with an acute uncomplicated cutaneous abscess received 4 placebo pills twice per day.	Participants with an acute uncomplicated cutaneous abscess received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.	Participants with an acute uncomplicated wound infection received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day, with alternating 1 identical placebo pill, twice per day.	Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses.	Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.	Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day.
Measure Participants	532	521	197	201	215	192
No reduction	2 0.4%	0 0%	1 0.5%	1 0.5%	2 0.9%	0 0%
>0%-5% reduction	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
>5%-10% reduction	0 0%	0 0%	0 0%	0 0%	0 0%	1 0.5%
>10%-15% reduction	0 0%	0 0%	1 0.5%	0 0%	0 0%	0 0%
>15%-20% reduction	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
>20%-25% reduction	0 0%	1 0.2%	0 0%	0 0%	0 0%	0 0%
>25%-30% reduction	0 0%	0 0%	1 0.5%	0 0%	0 0%	0 0%
>30%-35% reduction	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
>35%-40% reduction	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
>40%-45% reduction	0 0%	0 0%	0 0%	0 0%	1 0.5%	0 0%
>45%-50% reduction	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
>50%-55% reduction	0 0%	0 0%	1 0.5%	0 0%	0 0%	0 0%
>55%-60% reduction	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
>60%-65% reduction	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
>65%-70% reduction	0 0%	0 0%	1 0.5%	0 0%	1 0.5%	0 0%
>70%-75% reduction	0 0%	0 0%	1 0.5%	0 0%	2 0.9%	1 0.5%
>75%-80% reduction	2 0.4%	0 0%	0 0%	0 0%	1 0.5%	1 0.5%
>80%-85% reduction	0 0%	2 0.4%	0 0%	0 0%	1 0.5%	0 0%
>85%-90% reduction	4 0.8%	1 0.2%	0 0%	0 0%	0 0%	0 0%
>90%-95% reduction	4 0.8%	1 0.2%	0 0%	1 0.5%	0 0%	0 0%
>95%-100% reduction	520 97.6%	516 98.5%	191 96.5%	199 98%	207 95%	189 97.9%

8. Secondary Outcome

Title	Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Intent to Treat Population
Description	The area of erythema was measured in square centimeters at baseline and at the TOC visit. For each subject, the change in area was calculated as the area at TOC subtracted from the area at baseline. The change in area was then divided by the original area to determine the proportional change. Participants were then categorized by reductions in 5% intervals, with participants whose erythema did not change or increased categorized as no reduction.
Time Frame	Day 1 to Day 14-21

Outcome Measure Data

Analysis Population Description

All subjects who took at least one dose of study medication were included in the intent to treat population.

Arm/Group Title	Abscess, Placebo	Abscess, TMP/SMX	Infected Wound, TMP/SMX	Infected Wound, Clindamycin	Cellulitis, Cephalexin and TMP/SMX	Cellulitis, Cephalexin
Arm/Group Description	Participants with an acute uncomplicated cutaneous abscess received 4 placebo pills twice per day.	Participants with an acute uncomplicated cutaneous abscess received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.	Participants with an acute uncomplicated wound infection received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day, with alternating 1 identical placebo pill, twice per day.	Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses.	Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.	Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day.
Measure Participants	573	565	223	223	228	221
No reduction	2 0.4%	0 0%	1 0.5%	1 0.5%	2 0.9%	0 0%
>0%-5% reduction	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
>5%-10% reduction	0 0%	0 0%	0 0%	0 0%	0 0%	1 0.5%
>10%-15% reduction	0 0%	0 0%	1 0.5%	0 0%	0 0%	0 0%
>15%-20% reduction	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
>20%-25% reduction	0 0%	1 0.2%	0 0%	0 0%	0 0%	0 0%
>25%-30% reduction	0 0%	0 0%	1 0.5%	1 0.5%	0 0%	0 0%
>30%-35% reduction	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
>35%-40% reduction	0 0%	0 0%	0 0%	0 0%	0 0%	1 0.5%
>40%-45% reduction	0 0%	0 0%	0 0%	0 0%	1 0.5%	0 0%
>45%-50% reduction	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
>50%-55% reduction	0 0%	0 0%	1 0.5%	0 0%	0 0%	0 0%
>55%-60% reduction	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
>60%-65% reduction	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
>65%-70% reduction	0 0%	0 0%	1 0.5%	1 0.5%	1 0.5%	0 0%
>70%-75% reduction	0 0%	0 0%	1 0.5%	0 0%	2 0.9%	1 0.5%
>75%-80% reduction	2 0.4%	1 0.2%	0 0%	0 0%	1 0.5%	1 0.5%
>80%-85% reduction	0 0%	2 0.4%	0 0%	0 0%	1 0.5%	0 0%
>85%-90% reduction	4 0.8%	1 0.2%	0 0%	0 0%	0 0%	0 0%
>90%-95% reduction	4 0.8%	1 0.2%	1 0.5%	1 0.5%	0 0%	0 0%
>95%-100% reduction	561 105.3%	559 106.7%	216 109.1%	219 107.9%	220 100.9%	217 112.4%

9. Secondary Outcome

Title	Number of Participants by Composite Clinical Outcome at the TOC Visit in the Per Protocol Population
Description	Participants were categorized as composite clinical cure if they had resolution of all symptoms/signs of infection, or improvement to such an extent that no additional antibiotic therapy and/or surgical procedures were necessary. Participants were categorized as composite clinical failure if they had lack of resolution of all signs and symptoms of infection to such an extent that further antibiotic therapy and/or surgical procedures were necessary.
Time Frame	Day 14-21

Outcome Measure Data

Analysis Population Description

The analysis population is the per protocol population. All participants who met enrollment criteria, had none of the exclusion criteria, completed at least 75% of the first 5 days of antimicrobial therapy, and had physical follow-up at the Test of Cure (TOC) visit were included in the per protocol population.

Arm/Group Title	Abscess, Placebo	Abscess, TMP/SMX	Infected Wound, TMP/SMX	Infected Wound, Clindamycin	Cellulitis, Cephalexin and TMP/SMX	Cellulitis, Cephalexin
Arm/Group Description	Participants with an acute uncomplicated cutaneous abscess received 4 placebo pills twice per day.	Participants with an acute uncomplicated cutaneous abscess received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.	Participants with an acute uncomplicated wound infection received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day, with alternating 1 identical placebo pill, twice per day.	Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses.	Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.	Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day.
Measure Participants	533	524	198	203	218	193
Composite Clinical Cure	396 74.3%	453 86.5%	113 57.1%	114 56.2%	160 73.4%	149 77.2%
Composite Clinical Failure	137 25.7%	71 13.5%	85 42.9%	89 43.8%	58 26.6%	44 22.8%

10. Secondary Outcome

Title	Number of Participants With Each Microbiological Outcome at the TOC Visit in the Per Protocol Population
Description	Participants were categorized for the microbiological outcome with Presumed eradication if they were not deemed a clinical failure through TOC. Those who were deemed a clinical failure through the TOC were classified as one of the following: Persistence=persistent growth of a pre-therapy pathogen; New infection=growth of a new pathogen and eradication of initial pathogen; Super-infection=growth of a new pathogen in addition to persistent growth of pre-therapy pathogen; Unclassified=no specimen for culture or growth of a pathogen in subsequent culture specimen of cellulitis participants, or for whom initial culture specimens were negative or were not obtained for infected wound and abscess participants; or Indeterminate=not meeting any one of the above microbiologic outcome criteria.
Time Frame	Day 14-21

Outcome Measure Data

Analysis Population Description

The analysis population is the per protocol population. All participants who met enrollment criteria, had none of the exclusion criteria, completed at least 75% of the first 5 days of antimicrobial therapy, and had physical follow-up at the Test of Cure (TOC) visit were included in the per protocol population.

Arm/Group Title	Abscess, Placebo	Abscess, TMP/SMX	Infected Wound, TMP/SMX	Infected Wound, Clindamycin	Cellulitis, Cephalexin and TMP/SMX	Cellulitis, Cephalexin
Arm/Group Description	Participants with an acute uncomplicated cutaneous abscess received 4 placebo pills twice per day.	Participants with an acute uncomplicated cutaneous abscess received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.	Participants with an acute uncomplicated wound infection received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day, with alternating 1 identical placebo pill, twice per day.	Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses.	Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.	Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day.
Measure Participants	533	524	198	203	218	193
Presumed eradication	457 85.7%	487 92.9%	182 91.9%	187 92.1%	182 83.5%	165 85.5%
Persistence	39 7.3%	15 2.9%	5 2.5%	6 3%	0 0%	0 0%
New infection	1 0.2%	0 0%	2 1%	1 0.5%	0 0%	0 0%
Super-infection	8 1.5%	4 0.8%	0 0%	0 0%	0 0%	0 0%
Unclassified	28 5.3%	18 3.4%	9 4.5%	9 4.4%	13 6%	11 5.7%
Indeterminate	0 0%	0 0%	0 0%	0 0%	23 10.6%	17 8.8%

11. Secondary Outcome

Title	Number of Participants Requiring Surgical Intervention Through the TOC Visit in the Per Protocol Population
Description	All surgical procedures such as incision and drainage (I&D) and debridement that were related to the current infection under study or significant to the health of the subject, except for the initial I&D of an abscess for participants in the abscess or infected wound arms, were recorded. Participants who required a surgical intervention between the initial enrollment (excluding the initial I&D as applicable) and the test-of-cure visit are summarized.
Time Frame	Day 1 through Day 14-21

Outcome Measure Data

Analysis Population Description

The analysis population is the per protocol population. All participants who met enrollment criteria, had none of the exclusion criteria, completed at least 75% of the first 5 days of antimicrobial therapy, and had physical follow-up at the Test of Cure (TOC) visit were included in the per protocol population.

Arm/Group Title	Abscess, Placebo	Abscess, TMP/SMX	Infected Wound, TMP/SMX	Infected Wound, Clindamycin	Cellulitis, Cephalexin and TMP/SMX	Cellulitis, Cephalexin
Arm/Group Description	Participants with an acute uncomplicated cutaneous abscess received 4 placebo pills twice per day.	Participants with an acute uncomplicated cutaneous abscess received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.	Participants with an acute uncomplicated wound infection received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day, with alternating 1 identical placebo pill, twice per day.	Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses.	Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.	Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day.
Measure Participants	533	524	198	203	218	193
Number [participants]	46 8.6%	18 3.4%	13 6.6%	6 3%	26 11.9%	17 8.8%

12. Secondary Outcome

Title	Number of Participants Requiring Surgical Intervention Through the TOC Visit in the Intent to Treat Population
Description	All surgical procedures such as incision and drainage (I&D) and debridement that were related to the current infection under study or significant to the health of the subject, except for the initial I&D of an abscess for participants in the abscess or infected wound arms, were recorded. Participants who required a surgical intervention between the initial enrollment (excluding the initial I&D as applicable) and the test-of-cure visit are summarized.
Time Frame	Day 1 through Day 14-21

Outcome Measure Data

Analysis Population Description

All subjects who took at least one dose of study medication were included in the intent to treat population.

Arm/Group Title	Abscess, Placebo	Abscess, TMP/SMX	Infected Wound, TMP/SMX	Infected Wound, Clindamycin	Cellulitis, Cephalexin and TMP/SMX	Cellulitis, Cephalexin
Arm/Group Description	Participants with an acute uncomplicated cutaneous abscess received 4 placebo pills twice per day.	Participants with an acute uncomplicated cutaneous abscess received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.	Participants with an acute uncomplicated wound infection received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day, with alternating 1 identical placebo pill, twice per day.	Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses.	Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.	Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day.
Measure Participants	617	630	250	249	248	248
Number [participants]	52 9.8%	25 4.8%	16 8.1%	9 4.4%	26 11.9%	28 14.5%

13. Secondary Outcome

Title	Number of Participants Requiring Surgical Intervention Through the Extended Follow-up Visit (EFV) in the Per Protocol Population
Description	All surgical procedures such as incision and drainage (I&D) and debridement that were related to the current infection under study or significant to the health of the subject, except for the initial I&D of an abscess for participants in the abscess or infected wound arms, were recorded. Participants who required a surgical intervention between the initial enrollment (excluding the initial I&D as applicable) and the extended follow-up visit are summarized.
Time Frame	Day 1 through Day 49-63

Outcome Measure Data

Analysis Population Description

The analysis population is the per protocol population. All participants who met enrollment criteria, had none of the exclusion criteria, completed at least 75% of the first 5 days of antimicrobial therapy, and had physical follow-up at the Test of Cure (TOC) visit were included in the per protocol population.

Arm/Group Title	Abscess, Placebo	Abscess, TMP/SMX	Infected Wound, TMP/SMX	Infected Wound, Clindamycin	Cellulitis, Cephalexin and TMP/SMX	Cellulitis, Cephalexin
Arm/Group Description	Participants with an acute uncomplicated cutaneous abscess received 4 placebo pills twice per day.	Participants with an acute uncomplicated cutaneous abscess received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.	Participants with an acute uncomplicated wound infection received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day, with alternating 1 identical placebo pill, twice per day.	Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses.	Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.	Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day.
Measure Participants	533	524	198	203	218	193
Number [participants]	69 12.9%	42 8%	17 8.6%	8 3.9%	33 15.1%	20 10.4%

14. Secondary Outcome

Title	Number of Participants Requiring Surgical Intervention Through the Extended Follow-up Visit (EFV) in the Intent to Treat Population
Description	All surgical procedures such as incision and drainage (I&D) and debridement that were related to the current infection under study or significant to the health of the subject, except for the initial I&D of an abscess for participants in the abscess or infected wound arms, were recorded. Participants who required a surgical intervention between the initial enrollment (excluding the initial I&D as applicable) and the extended follow-up visit are summarized.
Time Frame	Day 1 through Day 49-63

Outcome Measure Data

Analysis Population Description

All subjects who took at least one dose of study medication were included in the intent to treat population.

Arm/Group Title	Abscess, Placebo	Abscess, TMP/SMX	Infected Wound, TMP/SMX	Infected Wound, Clindamycin	Cellulitis, Cephalexin and TMP/SMX	Cellulitis, Cephalexin
Arm/Group Description	Participants with an acute uncomplicated cutaneous abscess received 4 placebo pills twice per day.	Participants with an acute uncomplicated cutaneous abscess received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.	Participants with an acute uncomplicated wound infection received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day, with alternating 1 identical placebo pill, twice per day.	Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses.	Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.	Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day.
Measure Participants	617	630	250	249	248	248
Number [participants]	76 14.3%	52 9.9%	20 10.1%	12 5.9%	33 15.1%	31 16.1%

15. Secondary Outcome

Title	Number of Participants With Development of an Invasive Infection Through the TOC Visit in the Per Protocol Population
Description	Participants were evaluated for invasive infection, which included, but was not limited to, findings of severe sepsis/septic shock, endocarditis, pneumonia, necrotizing soft tissue, osteomyelitis, and bacteremia. A positive response to at least one finding was considered invasive infection for this outcome measure.
Time Frame	Day 1 through Day 14-21

Outcome Measure Data

Analysis Population Description

The analysis population is the per protocol population. All participants who met enrollment criteria, had none of the exclusion criteria, completed at least 75% of the first 5 days of antimicrobial therapy, and had physical follow-up at the Test of Cure (TOC) visit were included in the per protocol population.

Arm/Group Title	Abscess, Placebo	Abscess, TMP/SMX	Infected Wound, TMP/SMX	Infected Wound, Clindamycin	Cellulitis, Cephalexin and TMP/SMX	Cellulitis, Cephalexin
Arm/Group Description	Participants with an acute uncomplicated cutaneous abscess received 4 placebo pills twice per day.	Participants with an acute uncomplicated cutaneous abscess received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.	Participants with an acute uncomplicated wound infection received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day, with alternating 1 identical placebo pill, twice per day.	Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses.	Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.	Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day.
Measure Participants	533	524	198	203	218	193
Number [participants]	0 0%	1 0.2%	0 0%	0 0%	0 0%	0 0%

16. Secondary Outcome

Title	Number of Participants With Development of an Invasive Infection Through the TOC Visit in the Intent to Treat Population
Description	Participants were evaluated for invasive infection, which included, but was not limited to, findings of severe sepsis/septic shock, endocarditis, pneumonia, necrotizing soft tissue, osteomyelitis, and bacteremia. A positive response to at least one finding was considered invasive infection for this outcome measure.
Time Frame	Day 1 through Day 14-21

Outcome Measure Data

Analysis Population Description

All subjects who took at least one dose of study medication were included in the intent to treat population.

Arm/Group Title	Abscess, Placebo	Abscess, TMP/SMX	Infected Wound, TMP/SMX	Infected Wound, Clindamycin	Cellulitis, Cephalexin and TMP/SMX	Cellulitis, Cephalexin
Arm/Group Description	Participants with an acute uncomplicated cutaneous abscess received 4 placebo pills twice per day.	Participants with an acute uncomplicated cutaneous abscess received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.	Participants with an acute uncomplicated wound infection received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day, with alternating 1 identical placebo pill, twice per day.	Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses.	Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.	Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day.
Measure Participants	617	630	250	249	248	248
Number [participants]	1 0.2%	1 0.2%	0 0%	0 0%	0 0%	0 0%

17. Secondary Outcome

Title	Number of Participants With Development of an Invasive Infection Through the EFV Visit in the Per Protocol Population
Description	Participants were evaluated for invasive infection, which included, but was not limited to, findings of severe sepsis/septic shock, endocarditis, pneumonia, necrotizing soft tissue, osteomyelitis, and bacteremia. A positive response to at least one finding was considered invasive infection for this outcome measure.
Time Frame	Day 1 through Day 49-63

Outcome Measure Data

Analysis Population Description

The analysis population is the per protocol population. All participants who met enrollment criteria, had none of the exclusion criteria, completed at least 75% of the first 5 days of antimicrobial therapy, and had physical follow-up at the Test of Cure (TOC) visit were included in the per protocol population.

Arm/Group Title	Abscess, Placebo	Abscess, TMP/SMX	Infected Wound, TMP/SMX	Infected Wound, Clindamycin	Cellulitis, Cephalexin and TMP/SMX	Cellulitis, Cephalexin
Arm/Group Description	Participants with an acute uncomplicated cutaneous abscess received 4 placebo pills twice per day.	Participants with an acute uncomplicated cutaneous abscess received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.	Participants with an acute uncomplicated wound infection received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day, with alternating 1 identical placebo pill, twice per day.	Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses.	Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.	Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day.
Measure Participants	533	524	198	203	218	193
Number [participants]	2 0.4%	2 0.4%	0 0%	0 0%	1 0.5%	0 0%

18. Secondary Outcome

Title	Number of Participants With Development of an Invasive Infection Through the EFV Visit in the Intent to Treat Population
Description	Participants were evaluated for invasive infection, which included, but was not limited to, findings of severe sepsis/septic shock, endocarditis, pneumonia, necrotizing soft tissue, osteomyelitis, and bacteremia. A positive response to at least one finding was considered invasive infection for this outcome measure.
Time Frame	Day 1 through Day 49-63

Outcome Measure Data

Analysis Population Description

All subjects who took at least one dose of study medication were included in the intent to treat population.

Arm/Group Title	Abscess, Placebo	Abscess, TMP/SMX	Infected Wound, TMP/SMX	Infected Wound, Clindamycin	Cellulitis, Cephalexin and TMP/SMX	Cellulitis, Cephalexin
Arm/Group Description	Participants with an acute uncomplicated cutaneous abscess received 4 placebo pills twice per day.	Participants with an acute uncomplicated cutaneous abscess received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.	Participants with an acute uncomplicated wound infection received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day, with alternating 1 identical placebo pill, twice per day.	Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses.	Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.	Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day.
Measure Participants	617	630	250	249	248	248
Number [participants]	3 0.6%	2 0.4%	0 0%	0 0%	1 0.5%	0 0%

19. Secondary Outcome

Title	Number of Participants Who Developed a Recurrent Infection at the Original Infection Site Through the TOC Visit in the Per Protocol Population
Description	Participants were evaluated for the development of a recurrent, or repeat, infection at the original infection site. Participants who were reported to have developed a recurrent infection though the test-of-cure visit are summarized.
Time Frame	Day 1 through Day 14-21

Outcome Measure Data

Analysis Population Description

The analysis population is the per protocol population. All participants who met enrollment criteria, had none of the exclusion criteria, completed at least 75% of the first 5 days of antimicrobial therapy, and had physical follow-up at the Test of Cure (TOC) visit were included in the per protocol population.

Arm/Group Title	Abscess, Placebo	Abscess, TMP/SMX	Infected Wound, TMP/SMX	Infected Wound, Clindamycin	Cellulitis, Cephalexin and TMP/SMX	Cellulitis, Cephalexin
Arm/Group Description	Participants with an acute uncomplicated cutaneous abscess received 4 placebo pills twice per day.	Participants with an acute uncomplicated cutaneous abscess received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.	Participants with an acute uncomplicated wound infection received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day, with alternating 1 identical placebo pill, twice per day.	Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses.	Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.	Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day.
Measure Participants	533	524	198	203	218	193
Number [participants]	16 3%	11 2.1%	13 6.6%	3 1.5%	30 13.8%	22 11.4%

20. Secondary Outcome

Title	Number of Participants Who Developed a Recurrent Infection at the Original Infection Site Through the TOC Visit in the Intent to Treat Population
Description	Participants were evaluated for the development of a recurrent, or repeat, infection at the original infection site. Participants who were reported to have developed a recurrent infection though the test-of-cure visit are summarized.
Time Frame	Day 1 through Day 14-21

Outcome Measure Data

Analysis Population Description

All subjects who took at least one dose of study medication were included in the intent to treat population.

Arm/Group Title	Abscess, Placebo	Abscess, TMP/SMX	Infected Wound, TMP/SMX	Infected Wound, Clindamycin	Cellulitis, Cephalexin and TMP/SMX	Cellulitis, Cephalexin
Arm/Group Description	Participants with an acute uncomplicated cutaneous abscess received 4 placebo pills twice per day.	Participants with an acute uncomplicated cutaneous abscess received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.	Participants with an acute uncomplicated wound infection received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day, with alternating 1 identical placebo pill, twice per day.	Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses.	Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.	Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day.
Measure Participants	617	630	250	249	248	248
Number [participants]	17 3.2%	13 2.5%	15 7.6%	4 2%	32 14.7%	29 15%

21. Secondary Outcome

Title	Number of Participants Who Developed a Recurrent Infection at the Original Infection Site Through the EFV Visit in the Per Protocol Population
Description	Participants were evaluated for the development of a recurrent, or repeat, infection at the original infection site. Participants who were reported to have developed a recurrent infection though the extended follow-up visit are summarized.
Time Frame	Day 1 through Day 49-63

Outcome Measure Data

Analysis Population Description

The analysis population is the per protocol population. All participants who met enrollment criteria, had none of the exclusion criteria, completed at least 75% of the first 5 days of antimicrobial therapy, and had physical follow-up at the Test of Cure (TOC) visit were included in the per protocol population.

Arm/Group Title	Abscess, Placebo	Abscess, TMP/SMX	Infected Wound, TMP/SMX	Infected Wound, Clindamycin	Cellulitis, Cephalexin and TMP/SMX	Cellulitis, Cephalexin
Arm/Group Description	Participants with an acute uncomplicated cutaneous abscess received 4 placebo pills twice per day.	Participants with an acute uncomplicated cutaneous abscess received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.	Participants with an acute uncomplicated wound infection received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day, with alternating 1 identical placebo pill, twice per day.	Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses.	Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.	Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day.
Measure Participants	533	524	198	203	218	193
Number [participants]	23 4.3%	26 5%	14 7.1%	4 2%	33 15.1%	24 12.4%

22. Secondary Outcome

Title	Number of Participants Who Developed a Recurrent Infection at the Original Infection Site Through the EFV Visit in the Intent to Treat Population
Description	Participants were evaluated for the development of a recurrent, or repeat, infection at the original infection site. Participants who were reported to have developed a recurrent infection though the extended follow-up visit are summarized.
Time Frame	Day 1 through Day 49-63

Outcome Measure Data

Analysis Population Description

All subjects who took at least one dose of study medication were included in the intent to treat population.

Arm/Group Title	Abscess, Placebo	Abscess, TMP/SMX	Infected Wound, TMP/SMX	Infected Wound, Clindamycin	Cellulitis, Cephalexin and TMP/SMX	Cellulitis, Cephalexin
Arm/Group Description	Participants with an acute uncomplicated cutaneous abscess received 4 placebo pills twice per day.	Participants with an acute uncomplicated cutaneous abscess received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.	Participants with an acute uncomplicated wound infection received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day, with alternating 1 identical placebo pill, twice per day.	Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses.	Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.	Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day.
Measure Participants	617	630	250	249	248	248
Number [participants]	26 4.9%	30 5.7%	16 8.1%	6 3%	35 16.1%	31 16.1%

23. Secondary Outcome

Title	Number of Participants With Infections in Household Contacts Through the TOC Visit in the Per Protocol Population
Description	At each follow-up visit, participants were asked about history of skin infections in household members (e.g., similar skin infection in a family member). This outcome measure relied solely on participant reporting. Participants who reported having a family member with a similar infection though the test-of-cure visit are summarized.
Time Frame	Day 1 through Day 14-21

Outcome Measure Data

Analysis Population Description

The analysis population is the per protocol population. All participants who met enrollment criteria, had none of the exclusion criteria, completed at least 75% of the first 5 days of antimicrobial therapy, and had physical follow-up at the Test of Cure (TOC) visit were included in the per protocol population.

Arm/Group Title	Abscess, Placebo	Abscess, TMP/SMX	Infected Wound, TMP/SMX	Infected Wound, Clindamycin	Cellulitis, Cephalexin and TMP/SMX	Cellulitis, Cephalexin
Arm/Group Description	Participants with an acute uncomplicated cutaneous abscess received 4 placebo pills twice per day.	Participants with an acute uncomplicated cutaneous abscess received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.	Participants with an acute uncomplicated wound infection received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day, with alternating 1 identical placebo pill, twice per day.	Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses.	Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.	Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day.
Measure Participants	533	524	198	203	218	193
Number [participants]	22 4.1%	9 1.7%	1 0.5%	5 2.5%	6 2.8%	4 2.1%

24. Secondary Outcome

Title	Number of Participants With Infections in Household Contacts Through the TOC Visit in the Intent to Treat Population
Description	At each follow-up visit, participants were asked about history of skin infections in household members (e.g., similar skin infection in a family member). This outcome measure relied solely on participant reporting. Participants who reported having a family member with a similar infection though the test-of-cure visit are summarized.
Time Frame	Day 1 through Day 14-21

Outcome Measure Data

Analysis Population Description

All subjects who took at least one dose of study medication were included in the intent to treat population.

Arm/Group Title	Abscess, Placebo	Abscess, TMP/SMX	Infected Wound, TMP/SMX	Infected Wound, Clindamycin	Cellulitis, Cephalexin and TMP/SMX	Cellulitis, Cephalexin
Arm/Group Description	Participants with an acute uncomplicated cutaneous abscess received 4 placebo pills twice per day.	Participants with an acute uncomplicated cutaneous abscess received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.	Participants with an acute uncomplicated wound infection received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day, with alternating 1 identical placebo pill, twice per day.	Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses.	Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.	Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day.
Measure Participants	617	630	250	249	248	248
Number [participants]	22 4.1%	12 2.3%	1 0.5%	6 3%	7 3.2%	4 2.1%

25. Secondary Outcome

Title	Number of Participants With Infections in Household Contacts Through the EFV Visit in the Per Protocol Population
Description	At each follow-up visit, participants were asked about history of skin infections in household members (e.g., similar skin infection in a family member). This outcome measure relied solely on participant reporting. Participants who reported having a family member with a similar infection though the extended follow-up visit are summarized.
Time Frame	Day 1 through Day 49-63

Outcome Measure Data

Analysis Population Description

The analysis population is the per protocol population. All participants who met enrollment criteria, had none of the exclusion criteria, completed at least 75% of the first 5 days of antimicrobial therapy, and had physical follow-up at the Test of Cure (TOC) visit were included in the per protocol population.

Arm/Group Title	Abscess, Placebo	Abscess, TMP/SMX	Infected Wound, TMP/SMX	Infected Wound, Clindamycin	Cellulitis, Cephalexin and TMP/SMX	Cellulitis, Cephalexin
Arm/Group Description	Participants with an acute uncomplicated cutaneous abscess received 4 placebo pills twice per day.	Participants with an acute uncomplicated cutaneous abscess received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.	Participants with an acute uncomplicated wound infection received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day, with alternating 1 identical placebo pill, twice per day.	Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses.	Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.	Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day.
Measure Participants	533	524	198	203	218	193
Number [participants]	33 6.2%	20 3.8%	6 3%	9 4.4%	10 4.6%	5 2.6%

26. Secondary Outcome

Title	Number of Participants With Infections in Household Contacts Through the EFV Visit in the Intent to Treat Population
Description	At each follow-up visit, participants were asked about history of skin infections in household members (e.g., similar skin infection in a family member). This outcome measure relied solely on participant reporting. Participants who reported having a family member with a similar infection though the extended follow-up visit are summarized.
Time Frame	Day 1 through Day 49-63

Outcome Measure Data

Analysis Population Description

All subjects who took at least one dose of study medication were included in the intent to treat population.

Arm/Group Title	Abscess, Placebo	Abscess, TMP/SMX	Infected Wound, TMP/SMX	Infected Wound, Clindamycin	Cellulitis, Cephalexin and TMP/SMX	Cellulitis, Cephalexin
Arm/Group Description	Participants with an acute uncomplicated cutaneous abscess received 4 placebo pills twice per day.	Participants with an acute uncomplicated cutaneous abscess received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.	Participants with an acute uncomplicated wound infection received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day, with alternating 1 identical placebo pill, twice per day.	Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses.	Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.	Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day.
Measure Participants	617	630	250	249	248	248
Number [participants]	35 6.6%	25 4.8%	6 3%	11 5.4%	11 5%	5 2.6%

27. Secondary Outcome

Title	Number of Participants With Adverse Events Considered Associated With the Study Product by MedDRA System Organ Class
Description	All adverse events were recorded through the test of cure visit; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit. All AEs were assessed for association with the study product by a clinician and were considered associated with study product if the event was temporally related to the administration of the study product and no other etiology more likely explains the event. Associated adverse events are summarized by MedDRA System Organ Class.
Time Frame	Day 1 through Day 49-63

Outcome Measure Data

Analysis Population Description

All subjects who took at least one dose of study medication were included in the intent to treat population.

Arm/Group Title	Abscess, Placebo	Abscess, TMP/SMX	Infected Wound, TMP/SMX	Infected Wound, Clindamycin	Cellulitis, Cephalexin and TMP/SMX	Cellulitis, Cephalexin
Arm/Group Description	Participants with an acute uncomplicated cutaneous abscess received 4 placebo pills twice per day.	Participants with an acute uncomplicated cutaneous abscess received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.	Participants with an acute uncomplicated wound infection received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day, with alternating 1 identical placebo pill, twice per day.	Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses.	Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.	Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day.
Measure Participants	617	630	250	249	248	248
Cardiac disorders	0 0%	0 0%	0 0%	1 0.5%	0 0%	0 0%
Eye disorders	3 0.6%	1 0.2%	0 0%	0 0%	0 0%	0 0%
Gastrointestinal disorders	164 30.8%	198 37.8%	82 41.4%	93 45.8%	87 39.9%	73 37.8%
General disorders and administration site conditio	6 1.1%	11 2.1%	3 1.5%	1 0.5%	2 0.9%	2 1%
Infections and infestations	5 0.9%	4 0.8%	1 0.5%	1 0.5%	1 0.5%	1 0.5%
Injury, poisoning and procedural complications	1 0.2%	0 0%	0 0%	0 0%	0 0%	0 0%
Investigations	1 0.2%	0 0%	1 0.5%	0 0%	0 0%	0 0%
Metabolism and nutrition disorders	7 1.3%	11 2.1%	2 1%	4 2%	3 1.4%	0 0%
Musculoskeletal and connective tissue disorders	3 0.6%	3 0.6%	0 0%	0 0%	0 0%	0 0%
Nervous system disorders	38 7.1%	44 8.4%	16 8.1%	15 7.4%	16 7.3%	20 10.4%
Psychiatric disorders	0 0%	1 0.2%	0 0%	0 0%	0 0%	0 0%
Renal and urinary disorders	2 0.4%	0 0%	1 0.5%	0 0%	1 0.5%	0 0%
Reproductive system and breast disorders	1 0.2%	0 0%	0 0%	1 0.5%	1 0.5%	0 0%
Respiratory, thoracic and mediastinal disorders	3 0.6%	0 0%	0 0%	0 0%	0 0%	0 0%
Skin and subcutaneous tissue disorders	10 1.9%	14 2.7%	5 2.5%	6 3%	15 6.9%	7 3.6%
Vascular disorders	2 0.4%	0 0%	0 0%	0 0%	0 0%	0 0%

28. Secondary Outcome

Title	Mean Days Missed From Normal Activities in the Per Protocol Population
Description	As a quality of life measure, participants maintained a memory aid from Day 1 to Day 14 to track measures such as participation in normal life activities. The maximum number of days assessed, 14, was assigned to participants who had not yet resumed normal activities by the end of the assessment period.
Time Frame	Day 1 through 14

Outcome Measure Data

Analysis Population Description

The analysis population is the per protocol population. All participants who met enrollment criteria, had none of the exclusion criteria, completed at least 75% of the first 5 days of antimicrobial therapy, and had physical follow-up at the Test of Cure (TOC) visit were included in the per protocol population.

Arm/Group Title	Abscess, Placebo	Abscess, TMP/SMX	Infected Wound, TMP/SMX	Infected Wound, Clindamycin	Cellulitis, Cephalexin and TMP/SMX	Cellulitis, Cephalexin
Arm/Group Description	Participants with an acute uncomplicated cutaneous abscess received 4 placebo pills twice per day.	Participants with an acute uncomplicated cutaneous abscess received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.	Participants with an acute uncomplicated wound infection received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day, with alternating 1 identical placebo pill, twice per day.	Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses.	Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.	Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day.
Measure Participants	524	515	196	201	217	193
Mean (Standard Deviation) [days]	2.6 (3.8)	2.0 (3.1)	2.7 (4.1)	2.1 (3.5)	2.2 (3.2)	2.5 (3.9)

29. Secondary Outcome

Title	Mean Days Missed From Normal Activities in the Intent to Treat Population
Description	As a quality of life measure, participants maintained a memory aid from Day 1 to Day 14 to track measures such as participation in normal life activities. The maximum number of days assessed, 14, was assigned to participants who had not yet resumed normal activities by the end of the assessment period.
Time Frame	Day 1 through 14

Outcome Measure Data

Analysis Population Description

All subjects who took at least one dose of study medication were included in the intent to treat population.

Arm/Group Title	Abscess, Placebo	Abscess, TMP/SMX	Infected Wound, TMP/SMX	Infected Wound, Clindamycin	Cellulitis, Cephalexin and TMP/SMX	Cellulitis, Cephalexin
Arm/Group Description	Participants with an acute uncomplicated cutaneous abscess received 4 placebo pills twice per day.	Participants with an acute uncomplicated cutaneous abscess received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.	Participants with an acute uncomplicated wound infection received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day, with alternating 1 identical placebo pill, twice per day.	Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses.	Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.	Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day.
Measure Participants	585	584	234	238	236	230
Mean (Standard Deviation) [days]	2.5 (3.7)	2.1 (3.2)	2.6 (4.0)	2.1 (3.4)	2.2 (3.2)	2.7 (4.1)

30. Secondary Outcome

Title	Number of Participants Reporting 1-14 Days of Analgesic Use in the Per Protocol Population
Description	As a quality of life measure, participants maintained a memory aid from Day 1 to Day 14 to track measures such as use of other, non-study medications such as analgesics. Each participant is summarized by the last day of reported analgesic usage, from the start of treatment with study intervention. The maximum number of days assessed, 14, was assigned to participants who were still taking analgesic medications by the end of the assessment period.
Time Frame	Day 1 through 14

Outcome Measure Data

Analysis Population Description

The analysis population is the per protocol population. All participants who met enrollment criteria, had none of the exclusion criteria, completed at least 75% of the first 5 days of antimicrobial therapy, and had physical follow-up at the Test of Cure (TOC) visit were included in the per protocol population.

Arm/Group Title	Abscess, Placebo	Abscess, TMP/SMX	Infected Wound, TMP/SMX	Infected Wound, Clindamycin	Cellulitis, Cephalexin and TMP/SMX	Cellulitis, Cephalexin
Arm/Group Description	Participants with an acute uncomplicated cutaneous abscess received 4 placebo pills twice per day.	Participants with an acute uncomplicated cutaneous abscess received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.	Participants with an acute uncomplicated wound infection received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day, with alternating 1 identical placebo pill, twice per day.	Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses.	Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.	Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day.
Measure Participants	533	524	198	203	218	193
Day 1	44 8.3%	56 10.7%	23 11.6%	29 14.3%	14 6.4%	17 8.8%
Day 2	37 6.9%	32 6.1%	11 5.6%	9 4.4%	7 3.2%	5 2.6%
Day 3	41 7.7%	49 9.4%	17 8.6%	18 8.9%	13 6%	7 3.6%
Day 4	39 7.3%	32 6.1%	14 7.1%	9 4.4%	15 6.9%	7 3.6%
Day 5	24 4.5%	40 7.6%	7 3.5%	9 4.4%	9 4.1%	4 2.1%
Day 6	29 5.4%	27 5.2%	10 5.1%	11 5.4%	9 4.1%	19 9.8%
Day 7	24 4.5%	27 5.2%	10 5.1%	12 5.9%	9 4.1%	6 3.1%
Day 8	31 5.8%	35 6.7%	7 3.5%	10 4.9%	9 4.1%	5 2.6%
Day 9	22 4.1%	21 4%	3 1.5%	7 3.4%	9 4.1%	4 2.1%
Day 10	12 2.3%	13 2.5%	5 2.5%	4 2%	4 1.8%	3 1.6%
Day 11	16 3%	10 1.9%	2 1%	4 2%	3 1.4%	1 0.5%
Day 12	18 3.4%	12 2.3%	4 2%	1 0.5%	1 0.5%	6 3.1%
Day 13	12 2.3%	3 0.6%	2 1%	6 3%	2 0.9%	2 1%
Day 14	130 24.4%	107 20.4%	46 23.2%	40 19.7%	45 20.6%	38 19.7%

31. Secondary Outcome

Title	Number of Participants Reporting 1-14 Days of Analgesic Use in the Intent to Treat Population
Description	As a quality of life measure, participants maintained a memory aid from Day 1 to Day 14 to track measures such as use of other, non-study medications such as analgesics. Each participant is summarized by the last day of reported analgesic usage, from the start of treatment with study intervention. The maximum number of days assessed, 14, was assigned to participants who were still taking analgesic medications by the end of the assessment period.
Time Frame	Day 1 through 14

Outcome Measure Data

Analysis Population Description

All subjects who took at least one dose of study medication were included in the intent to treat population.

Arm/Group Title	Abscess, Placebo	Abscess, TMP/SMX	Infected Wound, TMP/SMX	Infected Wound, Clindamycin	Cellulitis, Cephalexin and TMP/SMX	Cellulitis, Cephalexin
Arm/Group Description	Participants with an acute uncomplicated cutaneous abscess received 4 placebo pills twice per day.	Participants with an acute uncomplicated cutaneous abscess received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.	Participants with an acute uncomplicated wound infection received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day, with alternating 1 identical placebo pill, twice per day.	Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses.	Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.	Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day.
Measure Participants	617	630	250	249	248	248
Day 1	58 10.9%	81 15.5%	32 16.2%	37 18.2%	18 8.3%	28 14.5%
Day 2	38 7.1%	34 6.5%	15 7.6%	10 4.9%	7 3.2%	6 3.1%
Day 3	45 8.4%	64 12.2%	18 9.1%	24 11.8%	15 6.9%	10 5.2%
Day 4	47 8.8%	34 6.5%	16 8.1%	10 4.9%	16 7.3%	13 6.7%
Day 5	27 5.1%	42 8%	9 4.5%	9 4.4%	10 4.6%	4 2.1%
Day 6	34 6.4%	29 5.5%	13 6.6%	13 6.4%	10 4.6%	22 11.4%
Day 7	27 5.1%	32 6.1%	13 6.6%	12 5.9%	9 4.1%	8 4.1%
Day 8	34 6.4%	40 7.6%	8 4%	11 5.4%	10 4.6%	6 3.1%
Day 9	24 4.5%	26 5%	4 2%	9 4.4%	9 4.1%	6 3.1%
Day 10	14 2.6%	15 2.9%	6 3%	4 2%	5 2.3%	4 2.1%
Day 11	19 3.6%	10 1.9%	2 1%	4 2%	3 1.4%	2 1%
Day 12	19 3.6%	14 2.7%	4 2%	3 1.5%	1 0.5%	6 3.1%
Day 13	15 2.8%	5 1%	2 1%	7 3.4%	2 0.9%	3 1.6%
Day 14	146 27.4%	127 24.2%	59 29.8%	50 24.6%	51 23.4%	45 23.3%

Adverse Events

Time Frame	All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
Arm/Group Title	Abscess, Placebo		Abscess, TMP/SMX		Infected Wound, TMP/SMX		Infected Wound, Clindamycin		Cellulitis, Cephalexin and TMP/SMX		Cellulitis, Cephalexin
Arm/Group Description	Participants with an acute uncomplicated cutaneous abscess received 4 placebo pills twice per day.		Participants with an acute uncomplicated cutaneous abscess received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.		Participants with an acute uncomplicated wound infection received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day, with alternating 1 identical placebo pill, twice per day.		Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses.		Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.		Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day.
All Cause Mortality
	Abscess, Placebo		Abscess, TMP/SMX		Infected Wound, TMP/SMX		Infected Wound, Clindamycin		Cellulitis, Cephalexin and TMP/SMX		Cellulitis, Cephalexin
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Abscess, Placebo		Abscess, TMP/SMX		Infected Wound, TMP/SMX		Infected Wound, Clindamycin		Cellulitis, Cephalexin and TMP/SMX		Cellulitis, Cephalexin
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	30/617 (4.9%)		21/630 (3.3%)		15/250 (6%)		11/249 (4.4%)		20/248 (8.1%)		21/248 (8.5%)
Blood and lymphatic system disorders
Pancytopenia	0/617 (0%)	0	1/630 (0.2%)	1	0/250 (0%)	0	0/249 (0%)	0	0/248 (0%)	0	0/248 (0%)	0
Cardiac disorders
Acute coronary syndrome	1/617 (0.2%)	1	0/630 (0%)	0	0/250 (0%)	0	0/249 (0%)	0	0/248 (0%)	0	0/248 (0%)	0
Bradycardia	1/617 (0.2%)	1	0/630 (0%)	0	0/250 (0%)	0	0/249 (0%)	0	0/248 (0%)	0	0/248 (0%)	0
Cardiomyopathy	1/617 (0.2%)	1	0/630 (0%)	0	0/250 (0%)	0	0/249 (0%)	0	0/248 (0%)	0	0/248 (0%)	0
Myocardial infarction	0/617 (0%)	0	1/630 (0.2%)	1	0/250 (0%)	0	0/249 (0%)	0	0/248 (0%)	0	0/248 (0%)	0
Gastrointestinal disorders
Abdominal pain	0/617 (0%)	0	1/630 (0.2%)	1	0/250 (0%)	0	0/249 (0%)	0	0/248 (0%)	0	0/248 (0%)	0
Anal fistula	1/617 (0.2%)	1	0/630 (0%)	0	0/250 (0%)	0	0/249 (0%)	0	0/248 (0%)	0	0/248 (0%)	0
General disorders
Chest pain	0/617 (0%)	0	1/630 (0.2%)	1	0/250 (0%)	0	0/249 (0%)	0	0/248 (0%)	0	0/248 (0%)	0
Death	0/617 (0%)	0	0/630 (0%)	0	1/250 (0.4%)	1	0/249 (0%)	0	0/248 (0%)	0	0/248 (0%)	0
Pyrexia	0/617 (0%)	0	1/630 (0.2%)	1	0/250 (0%)	0	0/249 (0%)	0	0/248 (0%)	0	0/248 (0%)	0
Infections and infestations
Abscess	8/617 (1.3%)	8	3/630 (0.5%)	3	1/250 (0.4%)	1	1/249 (0.4%)	1	3/248 (1.2%)	3	4/248 (1.6%)	4
Abscess limb	1/617 (0.2%)	1	1/630 (0.2%)	1	0/250 (0%)	0	0/249 (0%)	0	1/248 (0.4%)	1	0/248 (0%)	0
Appendicitis	0/617 (0%)	0	1/630 (0.2%)	1	0/250 (0%)	0	0/249 (0%)	0	0/248 (0%)	0	0/248 (0%)	0
Breast abscess	1/617 (0.2%)	1	0/630 (0%)	0	0/250 (0%)	0	0/249 (0%)	0	0/248 (0%)	0	0/248 (0%)	0
Bursitis infective	1/617 (0.2%)	1	0/630 (0%)	0	0/250 (0%)	0	0/249 (0%)	0	0/248 (0%)	0	0/248 (0%)	0
Cellulitis	9/617 (1.5%)	9	5/630 (0.8%)	6	5/250 (2%)	5	1/249 (0.4%)	1	9/248 (3.6%)	10	11/248 (4.4%)	11
Cellulitis staphylococcal	0/617 (0%)	0	0/630 (0%)	0	0/250 (0%)	0	1/249 (0.4%)	1	0/248 (0%)	0	0/248 (0%)	0
Clostridium difficile colitis	0/617 (0%)	0	0/630 (0%)	0	0/250 (0%)	0	0/249 (0%)	0	1/248 (0.4%)	1	0/248 (0%)	0
Coccidioidomycosis	0/617 (0%)	0	1/630 (0.2%)	1	0/250 (0%)	0	0/249 (0%)	0	0/248 (0%)	0	0/248 (0%)	0
Diverticulitis	0/617 (0%)	0	0/630 (0%)	0	0/250 (0%)	0	0/249 (0%)	0	1/248 (0.4%)	1	0/248 (0%)	0
Gastroenteritis	0/617 (0%)	0	1/630 (0.2%)	1	0/250 (0%)	0	0/249 (0%)	0	0/248 (0%)	0	0/248 (0%)	0
Infection	0/617 (0%)	0	0/630 (0%)	0	1/250 (0.4%)	1	0/249 (0%)	0	0/248 (0%)	0	0/248 (0%)	0
Localised infection	1/617 (0.2%)	1	0/630 (0%)	0	0/250 (0%)	0	0/249 (0%)	0	0/248 (0%)	0	0/248 (0%)	0
Necrotising fasciitis	0/617 (0%)	0	0/630 (0%)	0	0/250 (0%)	0	0/249 (0%)	0	1/248 (0.4%)	1	0/248 (0%)	0
Osteomyelitis	0/617 (0%)	0	0/630 (0%)	0	0/250 (0%)	0	0/249 (0%)	0	1/248 (0.4%)	1	0/248 (0%)	0
Periorbital cellulitis	0/617 (0%)	0	0/630 (0%)	0	0/250 (0%)	0	0/249 (0%)	0	1/248 (0.4%)	1	1/248 (0.4%)	1
Pneumonia	0/617 (0%)	0	1/630 (0.2%)	1	0/250 (0%)	0	0/249 (0%)	0	0/248 (0%)	0	0/248 (0%)	0
Pyelonephritis	1/617 (0.2%)	1	0/630 (0%)	0	0/250 (0%)	0	0/249 (0%)	0	0/248 (0%)	0	1/248 (0.4%)	1
Sepsis	0/617 (0%)	0	1/630 (0.2%)	1	0/250 (0%)	0	0/249 (0%)	0	0/248 (0%)	0	0/248 (0%)	0
Skin infection	0/617 (0%)	0	0/630 (0%)	0	0/250 (0%)	0	1/249 (0.4%)	1	0/248 (0%)	0	0/248 (0%)	0
Viral infection	1/617 (0.2%)	1	0/630 (0%)	0	0/250 (0%)	0	0/249 (0%)	0	0/248 (0%)	0	0/248 (0%)	0
Wound infection	0/617 (0%)	0	0/630 (0%)	0	4/250 (1.6%)	4	3/249 (1.2%)	3	0/248 (0%)	0	0/248 (0%)	0
Injury, poisoning and procedural complications
Lip injury	1/617 (0.2%)	1	0/630 (0%)	0	0/250 (0%)	0	0/249 (0%)	0	0/248 (0%)	0	0/248 (0%)	0
Road traffic accident	1/617 (0.2%)	1	0/630 (0%)	0	0/250 (0%)	0	0/249 (0%)	0	0/248 (0%)	0	1/248 (0.4%)	1
Wound complication	0/617 (0%)	0	0/630 (0%)	0	0/250 (0%)	0	1/249 (0.4%)	1	0/248 (0%)	0	0/248 (0%)	0
Metabolism and nutrition disorders
Acidosis	1/617 (0.2%)	1	0/630 (0%)	0	0/250 (0%)	0	0/249 (0%)	0	0/248 (0%)	0	0/248 (0%)	0
Diabetic ketoacidosis	1/617 (0.2%)	1	0/630 (0%)	0	0/250 (0%)	0	0/249 (0%)	0	0/248 (0%)	0	0/248 (0%)	0
Hyperglycaemia	0/617 (0%)	0	1/630 (0.2%)	1	0/250 (0%)	0	0/249 (0%)	0	1/248 (0.4%)	1	0/248 (0%)	0
Psychiatric disorders
Depression	0/617 (0%)	0	0/630 (0%)	0	1/250 (0.4%)	1	1/249 (0.4%)	1	0/248 (0%)	0	0/248 (0%)	0
Drug dependence	0/617 (0%)	0	0/630 (0%)	0	0/250 (0%)	0	1/249 (0.4%)	1	0/248 (0%)	0	0/248 (0%)	0
Mental disorder	0/617 (0%)	0	0/630 (0%)	0	0/250 (0%)	0	0/249 (0%)	0	0/248 (0%)	0	1/248 (0.4%)	1
Suicidal ideation	0/617 (0%)	0	1/630 (0.2%)	1	1/250 (0.4%)	1	1/249 (0.4%)	1	0/248 (0%)	0	0/248 (0%)	0
Suicide attempt	0/617 (0%)	0	1/630 (0.2%)	1	0/250 (0%)	0	0/249 (0%)	0	0/248 (0%)	0	0/248 (0%)	0
Renal and urinary disorders
Renal failure	0/617 (0%)	0	0/630 (0%)	0	0/250 (0%)	0	0/249 (0%)	0	0/248 (0%)	0	1/248 (0.4%)	1
Renal failure acute	1/617 (0.2%)	1	1/630 (0.2%)	1	1/250 (0.4%)	1	0/249 (0%)	0	1/248 (0.4%)	1	0/248 (0%)	0
Respiratory, thoracic and mediastinal disorders
Asthma	2/617 (0.3%)	2	0/630 (0%)	0	0/250 (0%)	0	0/249 (0%)	0	0/248 (0%)	0	0/248 (0%)	0
Chronic obstructive pulmonary disease	0/617 (0%)	0	1/630 (0.2%)	1	0/250 (0%)	0	0/249 (0%)	0	0/248 (0%)	0	0/248 (0%)	0
Pulmonary embolism	1/617 (0.2%)	1	0/630 (0%)	0	0/250 (0%)	0	0/249 (0%)	0	0/248 (0%)	0	0/248 (0%)	0
Skin and subcutaneous tissue disorders
Angioedema	0/617 (0%)	0	0/630 (0%)	0	0/250 (0%)	0	0/249 (0%)	0	0/248 (0%)	0	1/248 (0.4%)	1
Vascular disorders
Deep vein thrombosis	0/617 (0%)	0	0/630 (0%)	0	0/250 (0%)	0	0/249 (0%)	0	1/248 (0.4%)	1	0/248 (0%)	0
Hypertension	0/617 (0%)	0	0/630 (0%)	0	0/250 (0%)	0	0/249 (0%)	0	1/248 (0.4%)	1	1/248 (0.4%)	1
Other (Not Including Serious) Adverse Events
	Abscess, Placebo		Abscess, TMP/SMX		Infected Wound, TMP/SMX		Infected Wound, Clindamycin		Cellulitis, Cephalexin and TMP/SMX		Cellulitis, Cephalexin
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	331/617 (53.6%)		345/630 (54.8%)		138/250 (55.2%)		127/249 (51%)		157/248 (63.3%)		149/248 (60.1%)
Gastrointestinal disorders
Abdominal pain upper	26/617 (4.2%)	27	38/630 (6%)	40	17/250 (6.8%)	17	15/249 (6%)	20	19/248 (7.7%)	20	11/248 (4.4%)	11
Constipation	16/617 (2.6%)	16	25/630 (4%)	25	17/250 (6.8%)	18	1/249 (0.4%)	1	7/248 (2.8%)	7	5/248 (2%)	5
Diarrhoea	96/617 (15.6%)	102	94/630 (14.9%)	103	43/250 (17.2%)	48	81/249 (32.5%)	90	54/248 (21.8%)	59	47/248 (19%)	52
Nausea	102/617 (16.5%)	112	134/630 (21.3%)	141	50/250 (20%)	56	28/249 (11.2%)	29	49/248 (19.8%)	51	41/248 (16.5%)	42
Vomiting	40/617 (6.5%)	42	63/630 (10%)	64	22/250 (8.8%)	24	14/249 (5.6%)	14	19/248 (7.7%)	19	19/248 (7.7%)	21
General disorders
Pyrexia	25/617 (4.1%)	26	17/630 (2.7%)	17	2/250 (0.8%)	2	3/249 (1.2%)	3	13/248 (5.2%)	13	15/248 (6%)	16
Infections and infestations
Abscess	130/617 (21.1%)	152	88/630 (14%)	100	20/250 (8%)	26	12/249 (4.8%)	13	27/248 (10.9%)	29	33/248 (13.3%)	39
Cellulitis	5/617 (0.8%)	5	5/630 (0.8%)	5	6/250 (2.4%)	6	2/249 (0.8%)	2	27/248 (10.9%)	29	28/248 (11.3%)	28
Nervous system disorders
Dizziness	39/617 (6.3%)	41	41/630 (6.5%)	41	13/250 (5.2%)	14	13/249 (5.2%)	13	18/248 (7.3%)	20	16/248 (6.5%)	16
Headache	76/617 (12.3%)	81	100/630 (15.9%)	112	34/250 (13.6%)	36	27/249 (10.8%)	29	41/248 (16.5%)	45	42/248 (16.9%)	43
Skin and subcutaneous tissue disorders
Rash	9/617 (1.5%)	9	16/630 (2.5%)	16	6/250 (2.4%)	6	4/249 (1.6%)	4	14/248 (5.6%)	14	5/248 (2%)	5

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.