Trial · NCT01283581

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

NCT01283581, Phase 2, Completed, Melinta Therapeutics, Inc.; results first posted 2013-10-29

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Study to Assess Objective Endpoint Measurements of Response in Bacterial Skin Infections. Trials, record NCT01283581. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01283581

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Study to Assess Objective Endpoint Measurements of Response in Bacterial Skin Infections
NCT number: NCT01283581
Status: Completed
Phases: Phase 2
Enrollment: 256 participants, actual
Lead sponsor: Melinta Therapeutics, Inc.
Conditions: Skin and Subcutaneous Tissue Bacterial Infections
Interventions: Delafloxacin, Linezolid, Vancomycin
First posted: 2011-01-26
Last updated: 2019-10-16
Results first posted: 2013-10-29

Source ClinicalTrials.gov

Registered outcomes7

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	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	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%.
Secondary	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).
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.

Source ClinicalTrials.gov

Outcomes7

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Investigator's Assessment of Clinical Response in the ITT (Intent-to-treat) Population at Follow-up	Follow-up (Day 14 ± 1)	ITT (intent-to-treat) population, defined as all subjects who were randomized.	Participants	NUMBER
SECONDARY	Erythema Clinical Success	48 - 72 hours	ITT (intent-to-treat) population, defined as all subjects who were randomized.	Participants	NUMBER
SECONDARY	Pharmacokinetic (PK) Parameter, Area Under Curve, (AUCinf, ug*h/mL), in Subjects Administered Delafloxacin, Vancomycin, and Linezolid	Through Day 3 (± 1 day)	AUCinf (ug\*h/mL) for delafloxacin, linezolid, and vancomycin are presented only for those subjects with PK samples collected.	ug*h/mL	MEAN
SECONDARY	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)	Only subjects from ITT population with CRP levels evaluated were included in outcome measure analysis.	g/m3	MEAN
SECONDARY	Microbiological Response Rate in All Subjects (Microbiological Evaluable Population)	Follow-up (Day 14 ± 1)	Microbiologically Evaluable (ME) Population - All Subjects	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Microbiological Response Rate in Subjects With MRSA (Methicillin Resistant Staphylococcus Aureus) in Microbiological Evaluable (ME) Population	Follow-up (Day 14 ± 1)	Microbiologically Evaluable (ME) Population - MRSA Subjects	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Clinical Response in Subjects With Infections Caused by MRSA - Microbiological ITT (MITT) Population	Follow-up (Day 14 ± 1)	Microbiological ITT Population (MITT)	Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group51

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Investigator's Assessment of Clinical Response in the ITT (Intent-to-treat) Population at Follow-up	Delafloxacin IV		57		Participants
Investigator's Assessment of Clinical Response in the ITT (Intent-to-treat) Population at Follow-up	Linezolid		50		Participants
Investigator's Assessment of Clinical Response in the ITT (Intent-to-treat) Population at Follow-up	Vancomycin		53		Participants
Erythema Clinical Success	Delafloxacin IV		61		Participants
Erythema Clinical Success	Linezolid		56		Participants
Erythema Clinical Success	Vancomycin		69		Participants
Pharmacokinetic (PK) Parameter, Area Under Curve, (AUCinf, ug*h/mL), in Subjects Administered Delafloxacin, Vancomycin, and Linezolid	Delafloxacin		23.4	Standard Deviation 11.70	ug*h/mL
Pharmacokinetic (PK) Parameter, Area Under Curve, (AUCinf, ug*h/mL), in Subjects Administered Delafloxacin, Vancomycin, and Linezolid	Vancomycin		266.8	Standard Deviation 88.63	ug*h/mL
Pharmacokinetic (PK) Parameter, Area Under Curve, (AUCinf, ug*h/mL), in Subjects Administered Delafloxacin, Vancomycin, and Linezolid	Linezolid		106.0	Standard Deviation 47.33	ug*h/mL
The Levels of Inflammation Were Examined by Measuring a Surrogate, C-Reactive Protein (CRP)	Delafloxacin	Baseline	46.6	Standard Deviation 70.66	g/m3

1 to 10 of 51Source ClinicalTrials.gov

See all 51 results by group

Participant flow9

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Delafloxacin IV (Intravenous)	81
Overall Study	STARTED	Linezolid IV	77
Overall Study	STARTED	Vancomycin IV	98
Overall Study	COMPLETED	Delafloxacin IV (Intravenous)	69
Overall Study	COMPLETED	Linezolid IV	63
Overall Study	COMPLETED	Vancomycin IV	78
Overall Study	NOT COMPLETED	Delafloxacin IV (Intravenous)	12
Overall Study	NOT COMPLETED	Linezolid IV	14
Overall Study	NOT COMPLETED	Vancomycin IV	20

Source ClinicalTrials.gov

Adverse events90

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Constipation	Gastrointestinal disorders	Delafloxacin IV	1	78	1
other	Constipation	Gastrointestinal disorders	Linezolid	5	75	5
other	Constipation	Gastrointestinal disorders	Vancomycin	4	96	4
other	Diarrhoea	Gastrointestinal disorders	Delafloxacin IV	12	78	12
other	Diarrhoea	Gastrointestinal disorders	Linezolid	5	75	5
other	Diarrhoea	Gastrointestinal disorders	Vancomycin	4	96	4
other	Nausea	Gastrointestinal disorders	Delafloxacin IV	17	78	17
other	Nausea	Gastrointestinal disorders	Linezolid	16	75	16
other	Nausea	Gastrointestinal disorders	Vancomycin	13	96	13
other	Vomiting	Gastrointestinal disorders	Delafloxacin IV	10	78	10

1 to 10 of 90Source ClinicalTrials.gov

See all 90 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Delafloxacin IV
Total, all-cause mortality	Linezolid
Total, all-cause mortality	Vancomycin
Total, other adverse events	Delafloxacin IV	59	78
Total, other adverse events	Linezolid	54	75
Total, other adverse events	Vancomycin	62	96
Total, serious adverse events	Delafloxacin IV	5	78
Total, serious adverse events	Linezolid	2	75
Total, serious adverse events	Vancomycin	6	96

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
26679243	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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Read this trial from software.

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