Prospective Randomized Trial of Bactrim on 7 Day Outcome in Patients With Uncomplicated Abscesses

• Sponsor: 59th Medical Wing (U.S. Fed)
• Overall Status: Completed
• CT.gov ID: NCT00973765
• Collaborator: Emergency Medicine Foundation (Other)
• Enrollment: 212
• Location: 1
• Arms: 2
• Duration (Months): 21
• Patients Per Site Per Month: 10.1

Study Details

Study Description

Brief Summary

Patients will be enrolled in a multi-center study to prospectively evaluate outcome after treatment for an uncomplicated skin abscess. All patients will receive incision and drainage and wound cultures. Patients will then be randomized to 1) placebo two tablets PO BID X 7 days or 2) bactrim DS (800/160) two tablets PO BID x 7 days. Patients will then return to the emergency department ED) at 48 hours and 7 for wound repacking and evaluation. The primary outcome is treatment failure rates at 7 days after incision and drainage. Patients who are clinically worsening or not improving after 48 hours will then be treated with additional antibiotics or admission if needed. Data will be analyzed both by initial randomization and intention to treat.

Condition or Disease	Intervention/Treatment	Phase
Abscesses	Drug: bactrim; Drug: placebo	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 212 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Randomized Placebo-Controlled Trial of Bactrim on 7 Day Outcome in Emergency Department Patients With Uncomplicated Abscesses at Risk for Community Acquired Methicillin Resistant Staph Aureus
• Study Start Date: Nov 1, 2007
• Actual Primary Completion Date: Aug 1, 2009
• Actual Study Completion Date: Aug 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: bactrim DS (800/160) 2 pills po BID x 7 days active comparator	Drug: bactrim; bactrim DS (800/160) 2 pills PO BID x 7 days
Placebo Comparator: Matched placebo 2 pills po BID x 7 days placebo	Drug: placebo; placebo 2 pills po BID x 7 days

Outcome Measures

Primary Outcome Measures

1. Treatment Failures at 7 Days [7 days]

   worsening abscess or new recurrence of abscess

Eligibility Criteria

Criteria

• Ages Eligible for Study: 16 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Inclusion criteria include all patients age 16 and older who present to the emergency department with a skin abscess that requires incision and drainage.

Exclusion Criteria:

• Exclusion criteria include patients with diabetes, HIV, cancer or other immunocompromised patients.

• Additionally, any patients who received antibiotics within one week of presentation or were hospitalized in previous month will be excluded to minimize potential confounding variables.

• Pregnant and breastfeeding patients will also be excluded due to possible safety concerns with antibiotic treatment.

• Patients with abscesses on face, perirectal, or perianal regions, abscesses with known tracks or fistulas to deeper structures, or abscesses requiring surgical drainage in an operating room are excluded.

• Patients with fever or evidence of systemic infection

• Finally, patients with sulfa allergy will be excluded.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Wilford Hall Medical Center	Lackland Air Force Base	Texas	United States

Sponsors and Collaborators

• 59th Medical Wing
• Emergency Medicine Foundation

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00973765
• Other Study ID Numbers: FWH20080055H_
• First Posted: Sep 9, 2009
• Last Update Posted: Mar 9, 2010
• Last Verified: Sep 1, 2009

• Keywords provided by , ,: abcess; MRSA; cellulitis; antibiotics; uncomplicated abscesses
• Additional relevant MeSH terms: Abscess; Trimethoprim, Sulfamethoxazole Drug Combination

Study Results

Participant Flow

Recruitment Details	July 1, 2008 - June 1, 2009 in emergency department

Arm/Group Title	Active Comparator	Placebo
Arm/Group Description	Bactrim DS (800/160) 2 pills po BID x 7 days	Matched placebo 2 pills po BID x 7 days
Period Title: Overall Study
STARTED	96	116
COMPLETED	88	102
NOT COMPLETED	8	14

Baseline Characteristics

Arm/Group Title	Active Comparator	Placebo	Total
Arm/Group Description	Bactrim DS (800/160) 2 pills po BID x 7 days	Matched placebo 2 pills po BID x 7 days	Total of all reporting groups
Overall Participants	96	116	212
Age (Count of Participants)
<=18 years	1 1%	0 0%	1 0.5%
Between 18 and 65 years	94 97.9%	116 100%	210 99.1%
>=65 years	1 1%	0 0%	1 0.5%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	31.5 (13.3)	31.1 (12.5)	31.3 (12.8)
Sex: Female, Male (Count of Participants)
Female	28 29.2%	44 37.9%	72 34%
Male	68 70.8%	72 62.1%	140 66%
Region of Enrollment (participants) [Number]
United States	96 100%	116 100%	212 100%

Outcome Measures

1. Primary Outcome

Title	Treatment Failures at 7 Days
Description	worsening abscess or new recurrence of abscess
Time Frame	7 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Active Comparator	Placebo
Arm/Group Description	Bactrim DS (800/160) 2 pills po BID x 7 days	Matched placebo 2 pills po BID x 7 days
Measure Participants	96	116
Number [participants]	15 15.6%	27 23.3%

Adverse Events

Arm/Group Title	Active Comparator		Placebo
Arm/Group Description	Bactrim DS (800/160) 2 pills po BID x 7 days		Matched placebo 2 pills po BID x 7 days
All Cause Mortality
	Active Comparator		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Active Comparator		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/212 (0%)		0/212 (0%)
Other (Not Including Serious) Adverse Events
	Active Comparator		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.