A Study to Assess Objective Endpoint Measurements of Response in Bacterial Skin Infections

• Sponsor: Melinta Therapeutics, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01283581
• Collaborator: (none)
• Enrollment: 256
• Locations: 31
• Arms: 3
• Duration (Months): 10
• Patients Per Site: 8.3
• Patients Per Site Per Month: 0.8

Study Details

Study Description

Brief Summary

The purpose of this study is to compare clinical response to the measurement techniques of several objective measures of clinical efficacy for use in future ABSSSI (Acute Bacterial Skin and Skin Structure Infection) clinical trials

Condition or Disease	Intervention/Treatment	Phase
Skin and Subcutaneous Tissue Bacterial Infections	Drug: Delafloxacin; Drug: Linezolid; Drug: Vancomycin	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 256 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: A Phase 2 Exploratory Study of Objective Endpoints in Subjects With Acute Bacterial Skin and Skin Structure Infections Treated With Delafloxacin, Vancomycin, or Linezolid
• Study Start Date: Jan 1, 2011
• Actual Primary Completion Date: Nov 1, 2011
• Actual Study Completion Date: Nov 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Delafloxacin 300 mg IV (intravenous) every 12 hours for 5-14 days	Drug: Delafloxacin; 300mg IV every 12 hours for 5-14 days; Other Names: RX-3341
Active Comparator: Vancomycin 15 mg/kg, up to 1250 mg, IV every 12 hours for 5-14 dyas	Drug: Vancomycin; 15mg/kg, up to 1250 mg, IV every 12 hours for 5-14 days; Other Names: Vancocin
Active Comparator: Linezolid 600 mg IV every 12 hours for 5-14 days	Drug: Linezolid; 600mg IV every 12 hours for 5-14 days; Other Names: Zyvox

Outcome Measures

Primary Outcome Measures

1. Investigator's Assessment of Clinical Response in the ITT (Intent-to-treat) Population at Follow-up [Follow-up (Day 14 ± 1)]

   The primary efficacy endpoint was the success rate, defined as (cure)/(cure + failure), and expressed as a percentage. Cure was defined as the complete resolution of all baseline signs and symptoms of ABSSSI and follow-up and late follow-up. If erythema was the only sign of infection present at follow-up and it was then absent at late follow-up, the case was classified as a Cure.

Secondary Outcome Measures

1. Erythema Clinical Success [48 - 72 hours]

   The number of ITT subjects who had cessation of erythema within 48-72 hours, based on digital measurements, as well as resolution/absence of fever. Cessation was defined as a percentage change from baseline in total area of erythema/induration that is less than or equal to 0%.

2. Pharmacokinetic (PK) Parameter, Area Under Curve, (AUCinf, ug*h/mL), in Subjects Administered Delafloxacin, Vancomycin, and Linezolid [Through Day 3 (± 1 day)]

   Blood samples for pharmacokinetic analyses were drawn from all subjects on Day 3 (± 1 day) of treatment within 2 hours before the first study drug infusion and at 1, 2, 3, 5, and 12 hours (ie, immediately before the second dose) after the start of the first study drug infusion. An analytical, validated method was used to analyze samples and determine human plasma concentrations. The primary pharmacokinetic parameter calculated was area under the plasma concentration - time curve from time 0 extrapolated to infinity (AUCinf, ug*h/mL).

3. The Levels of Inflammation Were Examined by Measuring a Surrogate, C-Reactive Protein (CRP) [Baseline, Days 1, 5, Follow-up (FU), and late Follow-up (LFU)]

   CRP Levels (g/m3) were analyzed from blood samples collected from subjects at Baseline and various time points throughout the study. Change in baseline values were analyzed using an analysis of covariance (ANCOVA) model with treatment, infection category, and prior antimicrobial therapy as fixed effects and the baseline measure as the covariate.

4. Microbiological Response Rate in All Subjects (Microbiological Evaluable Population) [Follow-up (Day 14 ± 1)]

   Based on the results of the baseline and follow up cultures and susceptibility testing, together with the clinical response assigned by the investigator, the sponsor determined a microbiological response for subjects in the ME population.

5. Microbiological Response Rate in Subjects With MRSA (Methicillin Resistant Staphylococcus Aureus) in Microbiological Evaluable (ME) Population [Follow-up (Day 14 ± 1)]

   Based on the results of the baseline and follow up cultures and susceptibility testing, together with the clinical response assigned by the investigator, the sponsor determined a microbiological response for subjects in the ME population.

6. Clinical Response in Subjects With Infections Caused by MRSA - Microbiological ITT (MITT) Population [Follow-up (Day 14 ± 1)]

   The success rate, defined as (cure)/(cure + failure), and expressed as a percentage. Cure was defined as the complete resolution of all baseline signs and symptoms of ABSSSI and follow-up and late follow-up. If erythema was the only sign of infection present at follow-up and it was then absent at late follow-up, the case was classified as a Cure.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Adult (≥ 18 years of age) men or women

• Sexually active women and men with partners of childbearing potential must agree to use an acceptable form of contraception as determined by the investigator during participation in the study and for 30 days after the final dose of study drug

• Female partners of male subjects should also use an additional reliable method of contraception during study and for 30 days after the final dose of study drug

• Subjects must have a diagnosis of ABSSSI - one or more of the following 4 infection types: cellulitis/erysipelas, wound infection, major cutaneous abscess, or burn infection

• Subjects must have lymph node enlargement due to the present infection or at least one of the following symptoms of systemic infection: fever ≥ 38°C, lymphangitis, WBC (white blood cell) count ≥ 15,000 cells/μL, elevated C-reactive protein (> 5.0mg/L)

• In the opinion of the investigator, the subject must require and be a suitable candidate for IV antibiotic therapy

Exclusion Criteria:

• A medical history of significant hypersensitivity or allergic reaction to quinolones, linezolid, vancomycin, or vancomycin derivatives

• Women who are pregnant or lactating

• Any chronic or underlying skin condition at the site of infection that may complicate the assessment of response

• Subjects with any of the following: infection involving prosthetic materials or foreign bodies, infection associated with a human or animal bite, osteomyelitis, decubitus ulcer, diabetic foot ulcer, septic arthritis, mediastinitis, necrotizing fasciitis, anaerobic cellulitis, or synergistic necrotizing cellulitis, myositis, tendinitis, endocarditis, toxic shock syndrome, gangrene, burns covering ≥ 10% of body surface area, severely impaired arterial blood supply, current evidence of deep vein thrombosis or superficial thrombophlebitis

• Minor abscesses, unless present with one of the ABSSSI types

• Any infection expected to require other antimicrobial agents in addition to study drug

• Receipt of > 24 hours of systemic antibiotic therapy in the 14 days before enrollment unless one of the following is documented: the subject received a single dose of a short-acting antibacterial drug 3 or more days before clinical trial enrollment for surgical prophylaxis or recently completed treatment with an antibacterial drug for an infection other than ABSSSI and the drug does not have antibacterial activity against bacterial pathogens that cause ABSSSI

• Receipt of more than 1 dose of a potentially effective antibacterial agent for treatment of the ABSSSI under study prior to enrollment

• Receipt of chronic anti-inflammatory therapy for longer than 14 days before enrollment

• Severely compromised immune systems

• Subjects taking any medicinal product which inhibits monoamine oxidases A or B or within 2 weeks of Screening

• Hypertension as defined by a systolic blood pressure of ≥ 180 mmHg or a diastolic blood pressure of ≥110 mmHg with confirmed re-check within 20 minutes of initial reading

• Subjects with pheochromocytoma, thyrotoxicosis and/or subjects taking any of the following types of medications: sympathomimetic agents, vasopressive agents, dopaminergic agents, or other agents with the potential for serotonergic interactions

• Subjects with carcinoid syndrome and/or subjects taking any of the following medications: serotonin re-uptake inhibitors, tricyclic antidepressants, serotonin 5-HT1 (serotonin receptor) receptor agonists, meperidine, or buspirone

• Known history of liver disease

• History of severe renal impairment

• Life expectancy of < 3 months

• Any underlying disease that, in the opinion of the investigator, could interfere with the subject's ability to participate in the study

• Subjects previously randomized in this study or in who have received a dose of an investigational drug within 30 days of randomization

• Subjects > 140 kg in body weight

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of South Alabama Medical Center	Mobile	Alabama	United States	36617
2	Drug Research and Analysis Corp	Montgomery	Alabama	United States	36106
3	Southbay Pharma Research	Buena Park	California	United States	90620
4	eStudySite	Chula Vista	California	United States	91911
5	eStudySite	La Mesa	California	United States	91942
6	HealthCare Partners Medical Group	Los Angeles	California	United States	90015
7	eStudySite	Oceanside	California	United States	92056
8	HealthCare Partners Medical Group	Pasadena	California	United States	91105
9	Christiana Care Health Services	Newark	Delaware	United States	19713
10	Riverside Clinical Research	Edgewater	Florida	United States	32132
11	River City Clinical Research	Jacksonville	Florida	United States	32207
12	Central Florida Internists	Kissimmee	Florida	United States	34741
13	Central Florida Internists Medical	Orlando	Florida	United States	32811
14	Central Florida Internists	Saint Cloud	Florida	United States	34769
15	Ronald Barbour, MD	Temple Terrace	Florida	United States	33617
16	Southeast Regional Research Group	Columbus	Georgia	United States	31904
17	Atlanta Institute for Medical Research, Inc	Decatur	Georgia	United States	30030
18	Southeast Regional Research Group	Savannah	Georgia	United States	31406
19	University of Kansas Medical Center	Kansas City	Kansas	United States	66160
20	Four Rivers Clinical Research, Inc	Paducah	Kentucky	United States	42003
21	Medical Development Centers, LLC	Baton Rouge	Louisiana	United States	70810
22	University of Missouri Health Care	Columbia	Missouri	United States	65212
23	Mercury Street Medical Group, PLLC	Butte	Montana	United States	59701
24	eStudySite	Las Vegas	Nevada	United States	89109
25	South Jersey Infectious Disease	Somers Point	New Jersey	United States	08244
26	Montefiore Medical Center	Bronx	New York	United States	10467
27	Remington-Davis, Inc.	Columbus	Ohio	United States	43215
28	Ravi Kamepalli, MD	Lima	Ohio	United States	45801
29	Health Concepts	Rapid City	South Dakota	United States	57702
30	Jennifer Johnson-Caldwell, MD	Houston	Texas	United States	77002
31	Alan Nolasco, MD	Houston	Texas	United States	77005

Sponsors and Collaborators

• Melinta Therapeutics, Inc.

Investigators

• Study Director: Scott Hopkins, MD,

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Melinta Therapeutics, Inc.
• ClinicalTrials.gov Identifier: NCT01283581
• Other Study ID Numbers: RX-3341-202
• First Posted: Jan 26, 2011
• Last Update Posted: Oct 16, 2019
• Last Verified: Sep 1, 2019

• Additional relevant MeSH terms: Infections; Communicable Diseases; Bacterial Infections; Vancomycin; Linezolid

Study Results

Participant Flow

Recruitment Details	This study targeted patients with ABSSSI (acute bacterial skin and skin structure infections), defined as cellulitis/erysipelas, wound infection, major cutaneous abscess, or burn infection; the minimum surface area was to be 75 square centimeters.

Arm/Group Title	Delafloxacin IV (Intravenous)	Linezolid IV	Vancomycin IV
Arm/Group Description	Delafloxacin 300 mg, BID (twice a day)	Linezolid 600 mg, BID	Vancomycin 15 mg/kg or up to 1250 mg/dose, BID
Period Title: Overall Study
STARTED	81	77	98
COMPLETED	69	63	78
NOT COMPLETED	12	14	20

Baseline Characteristics

Arm/Group Title	Delafloxacin IV (Intravenous)	Linezolid	Vancomycin	Total
Arm/Group Description	Delafloxacin 300 mg, BID (twice a day)	Linezolid 600 mg, BID	Vancomycin 15 mg/kg or up to 1250 mg/dose, BID	Total of all reporting groups
Overall Participants	81	77	98	256
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	39.7 (14.26)	44.8 (14.91)	44.8 (15.54)	43.2 (15.08)
Sex: Female, Male (Count of Participants)
Female	32 39.5%	25 32.5%	47 48%	104 40.6%
Male	49 60.5%	52 67.5%	51 52%	152 59.4%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	19 23.5%	11 14.3%	27 27.6%	57 22.3%
Not Hispanic or Latino	62 76.5%	66 85.7%	71 72.4%	199 77.7%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	3 3.7%	2 2.6%	2 2%	7 2.7%
Asian	0 0%	1 1.3%	3 3.1%	4 1.6%
Native Hawaiian or Other Pacific Islander	3 3.7%	0 0%	0 0%	3 1.2%
Black or African American	10 12.3%	15 19.5%	15 15.3%	40 15.6%
White	63 77.8%	58 75.3%	74 75.5%	195 76.2%
More than one race	0 0%	0 0%	0 0%	0 0%
Unknown or Not Reported	2 2.5%	1 1.3%	4 4.1%	7 2.7%
Baseline Infection Category (Number) [Number]
Major cutaneous abscess	22 27.2%	24 31.2%	29 29.6%	75 29.3%
Cellulitis/erysipelas	38 46.9%	31 40.3%	44 44.9%	113 44.1%
Wound infection	19 23.5%	20 26%	23 23.5%	62 24.2%
Burn infection	2 2.5%	2 2.6%	1 1%	5 2%
Not assessed	0 0%	0 0%	1 1%	1 0.4%
Pathogens isolated at baseline (Number) [Number]
Subjects with at least 1 pathogen	51 63%	57 74%	67 68.4%	175 68.4%
Subjects with multiple pathogens	6 7.4%	15 19.5%	8 8.2%	29 11.3%
Subjects with positive blood cultures	0 0%	6 7.8%	1 1%	7 2.7%
Subjects without pathogens	30 37%	20 26%	31 31.6%	81 31.6%
Subjects with at least 1 Staphylococcus aureus	45 55.6%	53 68.8%	61 62.2%	159 62.1%
Subjects with at least 1 MRSA	34 42%	37 48.1%	35 35.7%	106 41.4%
Subjects with at least 1 MSSA	11 13.6%	16 20.8%	26 26.5%	53 20.7%

Outcome Measures

1. Primary Outcome

Title	Investigator's Assessment of Clinical Response in the ITT (Intent-to-treat) Population at Follow-up
Description	The primary efficacy endpoint was the success rate, defined as (cure)/(cure + failure), and expressed as a percentage. Cure was defined as the complete resolution of all baseline signs and symptoms of ABSSSI and follow-up and late follow-up. If erythema was the only sign of infection present at follow-up and it was then absent at late follow-up, the case was classified as a Cure.
Time Frame	Follow-up (Day 14 ± 1)

Outcome Measure Data

Analysis Population Description

ITT (intent-to-treat) population, defined as all subjects who were randomized.

Arm/Group Title	Delafloxacin IV	Linezolid	Vancomycin
Arm/Group Description	Delafloxacin 300 mg, BID	Linezolid 600 mg, BID	Vancomycin 15 mg/kg or up to 1250 mg/dose, BID
Measure Participants	81	77	98
Number [Participants]	57 70.4%	50 64.9%	53 54.1%

2. Secondary Outcome

Title	Erythema Clinical Success
Description	The number of ITT subjects who had cessation of erythema within 48-72 hours, based on digital measurements, as well as resolution/absence of fever. Cessation was defined as a percentage change from baseline in total area of erythema/induration that is less than or equal to 0%.
Time Frame	48 - 72 hours

Outcome Measure Data

Analysis Population Description

ITT (intent-to-treat) population, defined as all subjects who were randomized.

Arm/Group Title	Delafloxacin IV	Linezolid	Vancomycin
Arm/Group Description	Delafloxacin 300 mg, BID	Linezolid 600 mg, BID	Vancomycin 15 mg/kg or up to 1250 mg/dose, BID
Measure Participants	81	77	98
Number [Participants]	61 75.3%	56 72.7%	69 70.4%

3. Secondary Outcome

Title	Pharmacokinetic (PK) Parameter, Area Under Curve, (AUCinf, ug*h/mL), in Subjects Administered Delafloxacin, Vancomycin, and Linezolid
Description	Blood samples for pharmacokinetic analyses were drawn from all subjects on Day 3 (± 1 day) of treatment within 2 hours before the first study drug infusion and at 1, 2, 3, 5, and 12 hours (ie, immediately before the second dose) after the start of the first study drug infusion. An analytical, validated method was used to analyze samples and determine human plasma concentrations. The primary pharmacokinetic parameter calculated was area under the plasma concentration - time curve from time 0 extrapolated to infinity (AUCinf, ug*h/mL).
Time Frame	Through Day 3 (± 1 day)

Outcome Measure Data

Analysis Population Description

AUCinf (ug*h/mL) for delafloxacin, linezolid, and vancomycin are presented only for those subjects with PK samples collected.

Arm/Group Title	Delafloxacin	Vancomycin	Linezolid
Arm/Group Description	300 mg IV every 12 hours for 5-14 days Delafloxacin: 300mg IV every 12 hours for 5-14 days	15 mg/kg, up to 1250 mg, IV every 12 hours for 5-14 dyas Vancomycin: 15mg/kg, up to 1250 mg, IV every 12 hours for 5-14 days	600 mg IV every 12 hours for 5-14 days Linezolid: 600mg IV every 12 hours for 5-14 days
Measure Participants	57	35	42
Mean (Standard Deviation) [ug*h/mL]	23.4 (11.70)	266.8 (88.63)	106.0 (47.33)

4. Secondary Outcome

Title	The Levels of Inflammation Were Examined by Measuring a Surrogate, C-Reactive Protein (CRP)
Description	CRP Levels (g/m3) were analyzed from blood samples collected from subjects at Baseline and various time points throughout the study. Change in baseline values were analyzed using an analysis of covariance (ANCOVA) model with treatment, infection category, and prior antimicrobial therapy as fixed effects and the baseline measure as the covariate.
Time Frame	Baseline, Days 1, 5, Follow-up (FU), and late Follow-up (LFU)

Outcome Measure Data

Analysis Population Description

Only subjects from ITT population with CRP levels evaluated were included in outcome measure analysis.

Arm/Group Title	Delafloxacin	Vancomycin	Linezolid
Arm/Group Description	300 mg IV every 12 hours for 5-14 days Delafloxacin: 300mg IV every 12 hours for 5-14 days	15 mg/kg, up to 1250 mg, IV every 12 hours for 5-14 dyas Vancomycin: 15mg/kg, up to 1250 mg, IV every 12 hours for 5-14 days	600 mg IV every 12 hours for 5-14 days Linezolid: 600mg IV every 12 hours for 5-14 days
Measure Participants	81	98	77
Baseline	46.6 (70.66)	55.2 (69.70)	49.3 (56.14)
Day 1	44.2 (67.63)	49.6 (58.56)	49.8 (61.66)
Day 5	19.6 (35.97)	19.5 (22.63)	26.5 (48.44)
FU	9.4 (17.65)	11.9 (28.71)	12.1 (26.04)
LFU	10.8 (17.47)	9.3 (16.46)	12.6 (27.10)

5. Secondary Outcome

Title	Microbiological Response Rate in All Subjects (Microbiological Evaluable Population)
Description	Based on the results of the baseline and follow up cultures and susceptibility testing, together with the clinical response assigned by the investigator, the sponsor determined a microbiological response for subjects in the ME population.
Time Frame	Follow-up (Day 14 ± 1)

Outcome Measure Data

Analysis Population Description

Microbiologically Evaluable (ME) Population - All Subjects

Arm/Group Title	Delafloxacin	Vancomycin	Linezolid
Arm/Group Description	300 mg IV every 12 hours for 5-14 days Delafloxacin: 300mg IV every 12 hours for 5-14 days	15 mg/kg, up to 1250 mg, IV every 12 hours for 5-14 dyas Vancomycin: 15mg/kg, up to 1250 mg, IV every 12 hours for 5-14 days	600 mg IV every 12 hours for 5-14 days Linezolid: 600mg IV every 12 hours for 5-14 days
Measure Participants	34	52	39
Documented Eradicated	0 0%	0 0%	0 0%
Presumed Eradicated	30 37%	42 54.5%	32 32.7%
Documented Persisted	0 0%	0 0%	1 1%
Presumed Persisted	4 4.9%	10 13%	6 6.1%

6. Secondary Outcome

Title	Microbiological Response Rate in Subjects With MRSA (Methicillin Resistant Staphylococcus Aureus) in Microbiological Evaluable (ME) Population
Description	Based on the results of the baseline and follow up cultures and susceptibility testing, together with the clinical response assigned by the investigator, the sponsor determined a microbiological response for subjects in the ME population.
Time Frame	Follow-up (Day 14 ± 1)

Outcome Measure Data

Analysis Population Description

Microbiologically Evaluable (ME) Population - MRSA Subjects

Arm/Group Title	Delafloxacin	Vancomycin	Linezolid
Arm/Group Description	300 mg IV every 12 hours for 5-14 days Delafloxacin: 300mg IV every 12 hours for 5-14 days	15 mg/kg, up to 1250 mg, IV every 12 hours for 5-14 dyas Vancomycin: 15mg/kg, up to 1250 mg, IV every 12 hours for 5-14 days	600 mg IV every 12 hours for 5-14 days Linezolid: 600mg IV every 12 hours for 5-14 days
Measure Participants	21	26	25
Documented Eradicated	0 0%	0 0%	0 0%
Presumed Eradicated	18 22.2%	23 29.9%	20 20.4%
Documented Persisted	0 0%	0 0%	1 1%
Presumed Persisted	3 3.7%	3 3.9%	4 4.1%

7. Secondary Outcome

Title	Clinical Response in Subjects With Infections Caused by MRSA - Microbiological ITT (MITT) Population
Description	The success rate, defined as (cure)/(cure + failure), and expressed as a percentage. Cure was defined as the complete resolution of all baseline signs and symptoms of ABSSSI and follow-up and late follow-up. If erythema was the only sign of infection present at follow-up and it was then absent at late follow-up, the case was classified as a Cure.
Time Frame	Follow-up (Day 14 ± 1)

Outcome Measure Data

Analysis Population Description

Microbiological ITT Population (MITT)

Arm/Group Title	Delafloxacin	Vancomycin	Linezolid
Arm/Group Description	300 mg IV every 12 hours for 5-14 days Delafloxacin: 300mg IV every 12 hours for 5-14 days	15 mg/kg, up to 1250 mg, IV every 12 hours for 5-14 dyas Vancomycin: 15mg/kg, up to 1250 mg, IV every 12 hours for 5-14 days	600 mg IV every 12 hours for 5-14 days Linezolid: 600mg IV every 12 hours for 5-14 days
Measure Participants	29	32	34
Count of Participants [Participants]	19 23.5%	21 27.3%	21 21.4%

Adverse Events

Adverse Event Reporting Description	The safety population in this study was defined as all enrolled subjects who received at least 1 dose of study drug. The respective subjects numbers were 78 (delafloxacin), 75 (linezolid), and 96 (vancomycin).
Arm/Group Title	Delafloxacin IV		Linezolid		Vancomycin
Arm/Group Description	Delafloxacin 300 mg, BID		Linezolid 600 mg, BID		Vancomycin 15 mg/kg or up to 1250 mg/dose, BID
All Cause Mortality
	Delafloxacin IV		Linezolid		Vancomycin
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Delafloxacin IV		Linezolid		Vancomycin
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	5/78 (6.4%)		2/75 (2.7%)		6/96 (6.3%)
Blood and lymphatic system disorders
Anaemia	0/78 (0%)	0	0/75 (0%)	0	1/96 (1%)	1
Cardiac disorders
Cardiac Failure Congestive	1/78 (1.3%)	1	0/75 (0%)	0	1/96 (1%)	1
Gastrointestinal disorders
Abdominal Pain	0/78 (0%)	0	1/75 (1.3%)	1	1/96 (1%)	1
Diarrhoea	0/78 (0%)	0	0/75 (0%)	0	1/96 (1%)	1
Nausea	0/78 (0%)	0	0/75 (0%)	0	1/96 (1%)	1
Vomiting	0/78 (0%)	0	0/75 (0%)	0	1/96 (1%)	1
General disorders
Chest Pain	0/78 (0%)	0	0/75 (0%)	0	1/96 (1%)	1
Pyrexia	1/78 (1.3%)	1	0/75 (0%)	0	1/96 (1%)	1
Infections and infestations
Abscess	1/78 (1.3%)	1	0/75 (0%)	0	0/96 (0%)	0
Bacteraemia	1/78 (1.3%)	1	0/75 (0%)	0	0/96 (0%)	0
Cellulitis	1/78 (1.3%)	1	1/75 (1.3%)	1	1/96 (1%)	1
Infection	0/78 (0%)	0	0/75 (0%)	0	1/96 (1%)	1
Osteomyelitis	0/78 (0%)	0	0/75 (0%)	0	1/96 (1%)	1
Metabolism and nutrition disorders
Dehydration	0/78 (0%)	0	0/75 (0%)	0	1/96 (1%)	1
Nervous system disorders
Convulsion	2/78 (2.6%)	2	0/75 (0%)	0	0/96 (0%)	0
Renal and urinary disorders
Renal Failure Acute	0/78 (0%)	0	0/75 (0%)	0	1/96 (1%)	1
Other (Not Including Serious) Adverse Events
	Delafloxacin IV		Linezolid		Vancomycin
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	59/78 (75.6%)		54/75 (72%)		62/96 (64.6%)
Gastrointestinal disorders
Constipation	1/78 (1.3%)	1	5/75 (6.7%)	5	4/96 (4.2%)	4
Diarrhoea	12/78 (15.4%)	12	5/75 (6.7%)	5	4/96 (4.2%)	4
Nausea	17/78 (21.8%)	17	16/75 (21.3%)	16	13/96 (13.5%)	13
Vomiting	10/78 (12.8%)	10	6/75 (8%)	6	8/96 (8.3%)	8
Infusion Site Pain	4/78 (5.1%)	4	7/75 (9.3%)	7	5/96 (5.2%)	5
General disorders
Fatigue	5/78 (6.4%)	5	3/75 (4%)	3	6/96 (6.3%)	6
Infections and infestations
Abscess Limb	2/78 (2.6%)	2	4/75 (5.3%)	4	2/96 (2.1%)	2
Cellulitis	3/78 (3.8%)	3	3/75 (4%)	3	5/96 (5.2%)	5
Skin Infection	2/78 (2.6%)	2	4/75 (5.3%)	4	2/96 (2.1%)	2
Vulvovaginal Mycotic Infection	4/78 (5.1%)	4	0/75 (0%)	0	0/96 (0%)	0
Nervous system disorders
Dizziness	5/78 (6.4%)	5	1/75 (1.3%)	1	1/96 (1%)	1
Headache	5/78 (6.4%)	5	5/75 (6.7%)	5	5/96 (5.2%)	5
Skin and subcutaneous tissue disorders
Pruritis	6/78 (7.7%)	6	6/75 (8%)	6	20/96 (20.8%)	20
Rash	2/78 (2.6%)	2	5/75 (6.7%)	5	2/96 (2.1%)	2

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 more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.