Trial Outcomes & Findings for A Study to Assess Objective Endpoint Measurements of Response in Bacterial Skin Infections (NCT NCT01283581)
NCT ID: NCT01283581
Last Updated: 2019-10-16
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
256 participants
Primary outcome timeframe
Follow-up (Day 14 ± 1)
Results posted on
2019-10-16
Participant Flow
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.
Participant milestones
| Measure |
Delafloxacin IV (Intravenous)
Delafloxacin 300 mg, BID (twice a day)
|
Linezolid IV
Linezolid 600 mg, BID
|
Vancomycin IV
Vancomycin 15 mg/kg or up to 1250 mg/dose, BID
|
|---|---|---|---|
|
Overall Study
STARTED
|
81
|
77
|
98
|
|
Overall Study
COMPLETED
|
69
|
63
|
78
|
|
Overall Study
NOT COMPLETED
|
12
|
14
|
20
|
Reasons for withdrawal
| Measure |
Delafloxacin IV (Intravenous)
Delafloxacin 300 mg, BID (twice a day)
|
Linezolid IV
Linezolid 600 mg, BID
|
Vancomycin IV
Vancomycin 15 mg/kg or up to 1250 mg/dose, BID
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
8
|
6
|
8
|
|
Overall Study
Withdrawal by Subject
|
2
|
5
|
2
|
|
Overall Study
Adverse Event
|
1
|
1
|
4
|
|
Overall Study
Physician Decision
|
0
|
1
|
2
|
|
Overall Study
Protocol Violation
|
0
|
1
|
2
|
|
Overall Study
Noncompliance
|
1
|
0
|
0
|
|
Overall Study
Investigator unblinded
|
0
|
0
|
1
|
|
Overall Study
"Early termination"
|
0
|
0
|
1
|
Baseline Characteristics
A Study to Assess Objective Endpoint Measurements of Response in Bacterial Skin Infections
Baseline characteristics by cohort
| Measure |
Delafloxacin IV (Intravenous)
n=81 Participants
Delafloxacin 300 mg, BID (twice a day)
|
Linezolid
n=77 Participants
Linezolid 600 mg, BID
|
Vancomycin
n=98 Participants
Vancomycin 15 mg/kg or up to 1250 mg/dose, BID
|
Total
n=256 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
39.7 years
STANDARD_DEVIATION 14.26 • n=93 Participants
|
44.8 years
STANDARD_DEVIATION 14.91 • n=4 Participants
|
44.8 years
STANDARD_DEVIATION 15.54 • n=27 Participants
|
43.2 years
STANDARD_DEVIATION 15.08 • n=483 Participants
|
|
Sex: Female, Male
Female
|
32 Participants
n=93 Participants
|
25 Participants
n=4 Participants
|
47 Participants
n=27 Participants
|
104 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
49 Participants
n=93 Participants
|
52 Participants
n=4 Participants
|
51 Participants
n=27 Participants
|
152 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
19 Participants
n=93 Participants
|
11 Participants
n=4 Participants
|
27 Participants
n=27 Participants
|
57 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
62 Participants
n=93 Participants
|
66 Participants
n=4 Participants
|
71 Participants
n=27 Participants
|
199 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
3 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
7 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
4 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
3 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
3 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Black or African American
|
10 Participants
n=93 Participants
|
15 Participants
n=4 Participants
|
15 Participants
n=27 Participants
|
40 Participants
n=483 Participants
|
|
Race (NIH/OMB)
White
|
63 Participants
n=93 Participants
|
58 Participants
n=4 Participants
|
74 Participants
n=27 Participants
|
195 Participants
n=483 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
7 Participants
n=483 Participants
|
|
Baseline Infection Category
Major cutaneous abscess
|
22 Participants
n=93 Participants
|
24 Participants
n=4 Participants
|
29 Participants
n=27 Participants
|
75 Participants
n=483 Participants
|
|
Baseline Infection Category
Cellulitis/erysipelas
|
38 Participants
n=93 Participants
|
31 Participants
n=4 Participants
|
44 Participants
n=27 Participants
|
113 Participants
n=483 Participants
|
|
Baseline Infection Category
Wound infection
|
19 Participants
n=93 Participants
|
20 Participants
n=4 Participants
|
23 Participants
n=27 Participants
|
62 Participants
n=483 Participants
|
|
Baseline Infection Category
Burn infection
|
2 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
5 Participants
n=483 Participants
|
|
Baseline Infection Category
Not assessed
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
|
Pathogens isolated at baseline
Subjects with at least 1 pathogen
|
51 Participants
n=93 Participants
|
57 Participants
n=4 Participants
|
67 Participants
n=27 Participants
|
175 Participants
n=483 Participants
|
|
Pathogens isolated at baseline
Subjects with multiple pathogens
|
6 Participants
n=93 Participants
|
15 Participants
n=4 Participants
|
8 Participants
n=27 Participants
|
29 Participants
n=483 Participants
|
|
Pathogens isolated at baseline
Subjects with positive blood cultures
|
0 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
7 Participants
n=483 Participants
|
|
Pathogens isolated at baseline
Subjects without pathogens
|
30 Participants
n=93 Participants
|
20 Participants
n=4 Participants
|
31 Participants
n=27 Participants
|
81 Participants
n=483 Participants
|
|
Pathogens isolated at baseline
Subjects with at least 1 Staphylococcus aureus
|
45 Participants
n=93 Participants
|
53 Participants
n=4 Participants
|
61 Participants
n=27 Participants
|
159 Participants
n=483 Participants
|
|
Pathogens isolated at baseline
Subjects with at least 1 MRSA
|
34 Participants
n=93 Participants
|
37 Participants
n=4 Participants
|
35 Participants
n=27 Participants
|
106 Participants
n=483 Participants
|
|
Pathogens isolated at baseline
Subjects with at least 1 MSSA
|
11 Participants
n=93 Participants
|
16 Participants
n=4 Participants
|
26 Participants
n=27 Participants
|
53 Participants
n=483 Participants
|
PRIMARY outcome
Timeframe: Follow-up (Day 14 ± 1)Population: ITT (intent-to-treat) population, defined as all subjects who were randomized.
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.
Outcome measures
| Measure |
Delafloxacin IV
n=81 Participants
Delafloxacin 300 mg, BID
|
Linezolid
n=77 Participants
Linezolid 600 mg, BID
|
Vancomycin
n=98 Participants
Vancomycin 15 mg/kg or up to 1250 mg/dose, BID
|
|---|---|---|---|
|
Investigator's Assessment of Clinical Response in the ITT (Intent-to-treat) Population at Follow-up
|
57 Participants
|
50 Participants
|
53 Participants
|
SECONDARY outcome
Timeframe: 48 - 72 hoursPopulation: ITT (intent-to-treat) population, defined as all subjects who were randomized.
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%.
Outcome measures
| Measure |
Delafloxacin IV
n=81 Participants
Delafloxacin 300 mg, BID
|
Linezolid
n=77 Participants
Linezolid 600 mg, BID
|
Vancomycin
n=98 Participants
Vancomycin 15 mg/kg or up to 1250 mg/dose, BID
|
|---|---|---|---|
|
Erythema Clinical Success
|
61 Participants
|
56 Participants
|
69 Participants
|
SECONDARY outcome
Timeframe: Through Day 3 (± 1 day)Population: AUCinf (ug\*h/mL) for delafloxacin, linezolid, and vancomycin are presented only for those subjects with PK samples collected.
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).
Outcome measures
| Measure |
Delafloxacin IV
n=57 Participants
Delafloxacin 300 mg, BID
|
Linezolid
n=35 Participants
Linezolid 600 mg, BID
|
Vancomycin
n=42 Participants
Vancomycin 15 mg/kg or up to 1250 mg/dose, BID
|
|---|---|---|---|
|
Pharmacokinetic (PK) Parameter, Area Under Curve, (AUCinf, ug*h/mL), in Subjects Administered Delafloxacin, Vancomycin, and Linezolid
|
23.4 ug*h/mL
Standard Deviation 11.70
|
266.8 ug*h/mL
Standard Deviation 88.63
|
106.0 ug*h/mL
Standard Deviation 47.33
|
SECONDARY outcome
Timeframe: Baseline, Days 1, 5, Follow-up (FU), and late Follow-up (LFU)Population: Only subjects from ITT population with CRP levels evaluated were included in outcome measure analysis.
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.
Outcome measures
| Measure |
Delafloxacin IV
n=81 Participants
Delafloxacin 300 mg, BID
|
Linezolid
n=98 Participants
Linezolid 600 mg, BID
|
Vancomycin
n=77 Participants
Vancomycin 15 mg/kg or up to 1250 mg/dose, BID
|
|---|---|---|---|
|
The Levels of Inflammation Were Examined by Measuring a Surrogate, C-Reactive Protein (CRP)
Baseline
|
46.6 g/m3
Standard Deviation 70.66
|
55.2 g/m3
Standard Deviation 69.70
|
49.3 g/m3
Standard Deviation 56.14
|
|
The Levels of Inflammation Were Examined by Measuring a Surrogate, C-Reactive Protein (CRP)
Day 1
|
44.2 g/m3
Standard Deviation 67.63
|
49.6 g/m3
Standard Deviation 58.56
|
49.8 g/m3
Standard Deviation 61.66
|
|
The Levels of Inflammation Were Examined by Measuring a Surrogate, C-Reactive Protein (CRP)
Day 5
|
19.6 g/m3
Standard Deviation 35.97
|
19.5 g/m3
Standard Deviation 22.63
|
26.5 g/m3
Standard Deviation 48.44
|
|
The Levels of Inflammation Were Examined by Measuring a Surrogate, C-Reactive Protein (CRP)
FU
|
9.4 g/m3
Standard Deviation 17.65
|
11.9 g/m3
Standard Deviation 28.71
|
12.1 g/m3
Standard Deviation 26.04
|
|
The Levels of Inflammation Were Examined by Measuring a Surrogate, C-Reactive Protein (CRP)
LFU
|
10.8 g/m3
Standard Deviation 17.47
|
9.3 g/m3
Standard Deviation 16.46
|
12.6 g/m3
Standard Deviation 27.10
|
SECONDARY outcome
Timeframe: Follow-up (Day 14 ± 1)Population: Microbiologically Evaluable (ME) Population - All Subjects
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.
Outcome measures
| Measure |
Delafloxacin IV
n=34 Participants
Delafloxacin 300 mg, BID
|
Linezolid
n=52 Participants
Linezolid 600 mg, BID
|
Vancomycin
n=39 Participants
Vancomycin 15 mg/kg or up to 1250 mg/dose, BID
|
|---|---|---|---|
|
Microbiological Response Rate in All Subjects (Microbiological Evaluable Population)
Documented Persisted
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Microbiological Response Rate in All Subjects (Microbiological Evaluable Population)
Documented Eradicated
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Microbiological Response Rate in All Subjects (Microbiological Evaluable Population)
Presumed Eradicated
|
30 Participants
|
42 Participants
|
32 Participants
|
|
Microbiological Response Rate in All Subjects (Microbiological Evaluable Population)
Presumed Persisted
|
4 Participants
|
10 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Follow-up (Day 14 ± 1)Population: Microbiologically Evaluable (ME) Population - MRSA Subjects
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.
Outcome measures
| Measure |
Delafloxacin IV
n=21 Participants
Delafloxacin 300 mg, BID
|
Linezolid
n=26 Participants
Linezolid 600 mg, BID
|
Vancomycin
n=25 Participants
Vancomycin 15 mg/kg or up to 1250 mg/dose, BID
|
|---|---|---|---|
|
Microbiological Response Rate in Subjects With MRSA (Methicillin Resistant Staphylococcus Aureus) in Microbiological Evaluable (ME) Population
Documented Persisted
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Microbiological Response Rate in Subjects With MRSA (Methicillin Resistant Staphylococcus Aureus) in Microbiological Evaluable (ME) Population
Presumed Persisted
|
3 Participants
|
3 Participants
|
4 Participants
|
|
Microbiological Response Rate in Subjects With MRSA (Methicillin Resistant Staphylococcus Aureus) in Microbiological Evaluable (ME) Population
Documented Eradicated
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Microbiological Response Rate in Subjects With MRSA (Methicillin Resistant Staphylococcus Aureus) in Microbiological Evaluable (ME) Population
Presumed Eradicated
|
18 Participants
|
23 Participants
|
20 Participants
|
SECONDARY outcome
Timeframe: Follow-up (Day 14 ± 1)Population: Microbiological ITT Population (MITT)
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.
Outcome measures
| Measure |
Delafloxacin IV
n=29 Participants
Delafloxacin 300 mg, BID
|
Linezolid
n=32 Participants
Linezolid 600 mg, BID
|
Vancomycin
n=34 Participants
Vancomycin 15 mg/kg or up to 1250 mg/dose, BID
|
|---|---|---|---|
|
Clinical Response in Subjects With Infections Caused by MRSA - Microbiological ITT (MITT) Population
|
19 Participants
|
21 Participants
|
21 Participants
|
Adverse Events
Delafloxacin IV
Serious events: 5 serious events
Other events: 59 other events
Deaths: 0 deaths
Linezolid
Serious events: 2 serious events
Other events: 54 other events
Deaths: 0 deaths
Vancomycin
Serious events: 6 serious events
Other events: 62 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Delafloxacin IV
n=78 participants at risk
Delafloxacin 300 mg, BID
|
Linezolid
n=75 participants at risk
Linezolid 600 mg, BID
|
Vancomycin
n=96 participants at risk
Vancomycin 15 mg/kg or up to 1250 mg/dose, BID
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/78
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).
|
0.00%
0/75
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).
|
1.0%
1/96 • Number of events 1
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).
|
|
Cardiac disorders
Cardiac Failure Congestive
|
1.3%
1/78 • Number of events 1
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).
|
0.00%
0/75
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).
|
1.0%
1/96 • Number of events 1
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).
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/78
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).
|
1.3%
1/75 • Number of events 1
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).
|
1.0%
1/96 • Number of events 1
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).
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/78
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).
|
0.00%
0/75
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).
|
1.0%
1/96 • Number of events 1
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).
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/78
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).
|
0.00%
0/75
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).
|
1.0%
1/96 • Number of events 1
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).
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/78
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).
|
0.00%
0/75
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).
|
1.0%
1/96 • Number of events 1
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).
|
|
General disorders
Chest Pain
|
0.00%
0/78
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).
|
0.00%
0/75
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).
|
1.0%
1/96 • Number of events 1
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).
|
|
General disorders
Pyrexia
|
1.3%
1/78 • Number of events 1
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).
|
0.00%
0/75
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).
|
1.0%
1/96 • Number of events 1
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).
|
|
Infections and infestations
Abscess
|
1.3%
1/78 • Number of events 1
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).
|
0.00%
0/75
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).
|
0.00%
0/96
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).
|
|
Infections and infestations
Bacteraemia
|
1.3%
1/78 • Number of events 1
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).
|
0.00%
0/75
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).
|
0.00%
0/96
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).
|
|
Infections and infestations
Cellulitis
|
1.3%
1/78 • Number of events 1
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).
|
1.3%
1/75 • Number of events 1
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).
|
1.0%
1/96 • Number of events 1
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).
|
|
Infections and infestations
Infection
|
0.00%
0/78
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).
|
0.00%
0/75
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).
|
1.0%
1/96 • Number of events 1
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).
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/78
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).
|
0.00%
0/75
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).
|
1.0%
1/96 • Number of events 1
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).
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/78
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).
|
0.00%
0/75
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).
|
1.0%
1/96 • Number of events 1
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).
|
|
Nervous system disorders
Convulsion
|
2.6%
2/78 • Number of events 2
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).
|
0.00%
0/75
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).
|
0.00%
0/96
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).
|
|
Renal and urinary disorders
Renal Failure Acute
|
0.00%
0/78
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).
|
0.00%
0/75
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).
|
1.0%
1/96 • Number of events 1
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).
|
Other adverse events
| Measure |
Delafloxacin IV
n=78 participants at risk
Delafloxacin 300 mg, BID
|
Linezolid
n=75 participants at risk
Linezolid 600 mg, BID
|
Vancomycin
n=96 participants at risk
Vancomycin 15 mg/kg or up to 1250 mg/dose, BID
|
|---|---|---|---|
|
Gastrointestinal disorders
Constipation
|
1.3%
1/78 • Number of events 1
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).
|
6.7%
5/75 • Number of events 5
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).
|
4.2%
4/96 • Number of events 4
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).
|
|
Gastrointestinal disorders
Diarrhoea
|
15.4%
12/78 • Number of events 12
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).
|
6.7%
5/75 • Number of events 5
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).
|
4.2%
4/96 • Number of events 4
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).
|
|
Gastrointestinal disorders
Nausea
|
21.8%
17/78 • Number of events 17
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).
|
21.3%
16/75 • Number of events 16
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).
|
13.5%
13/96 • Number of events 13
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).
|
|
Gastrointestinal disorders
Vomiting
|
12.8%
10/78 • Number of events 10
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).
|
8.0%
6/75 • Number of events 6
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).
|
8.3%
8/96 • Number of events 8
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).
|
|
General disorders
Fatigue
|
6.4%
5/78 • Number of events 5
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).
|
4.0%
3/75 • Number of events 3
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).
|
6.2%
6/96 • Number of events 6
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).
|
|
Gastrointestinal disorders
Infusion Site Pain
|
5.1%
4/78 • Number of events 4
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).
|
9.3%
7/75 • Number of events 7
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).
|
5.2%
5/96 • Number of events 5
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).
|
|
Infections and infestations
Abscess Limb
|
2.6%
2/78 • Number of events 2
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).
|
5.3%
4/75 • Number of events 4
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).
|
2.1%
2/96 • Number of events 2
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).
|
|
Infections and infestations
Cellulitis
|
3.8%
3/78 • Number of events 3
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).
|
4.0%
3/75 • Number of events 3
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).
|
5.2%
5/96 • Number of events 5
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).
|
|
Infections and infestations
Skin Infection
|
2.6%
2/78 • Number of events 2
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).
|
5.3%
4/75 • Number of events 4
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).
|
2.1%
2/96 • Number of events 2
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).
|
|
Infections and infestations
Vulvovaginal Mycotic Infection
|
5.1%
4/78 • Number of events 4
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).
|
0.00%
0/75
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).
|
0.00%
0/96
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).
|
|
Nervous system disorders
Dizziness
|
6.4%
5/78 • Number of events 5
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).
|
1.3%
1/75 • Number of events 1
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).
|
1.0%
1/96 • Number of events 1
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).
|
|
Nervous system disorders
Headache
|
6.4%
5/78 • Number of events 5
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).
|
6.7%
5/75 • Number of events 5
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).
|
5.2%
5/96 • Number of events 5
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).
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
7.7%
6/78 • Number of events 6
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).
|
8.0%
6/75 • Number of events 6
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).
|
20.8%
20/96 • Number of events 20
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).
|
|
Skin and subcutaneous tissue disorders
Rash
|
2.6%
2/78 • Number of events 2
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).
|
6.7%
5/75 • Number of events 5
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).
|
2.1%
2/96 • Number of events 2
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).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60