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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
256
300mg IV every 12 hours for 5-14 days
600mg IV every 12 hours for 5-14 days
15mg/kg, up to 1250 mg, IV every 12 hours for 5-14 days
Investigator's Assessment of Clinical Response in the ITT (Intent-to-treat) Population at Follow-up
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)
Erythema Clinical Success
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
Pharmacokinetic (PK) Parameter, Area Under Curve, (AUCinf, ug*h/mL), in Subjects Administered Delafloxacin, Vancomycin, and Linezolid
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)
The Levels of Inflammation Were Examined by Measuring a Surrogate, C-Reactive Protein (CRP)
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.
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University of South Alabama Medical Center
Mobile, Alabama, United States
Drug Research and Analysis Corp
Montgomery, Alabama, United States
Southbay Pharma Research
Buena Park, California, United States
eStudySite
Chula Vista, California, United States
eStudySite
La Mesa, California, United States
HealthCare Partners Medical Group
Los Angeles, California, United States
eStudySite
Oceanside, California, United States
HealthCare Partners Medical Group
Pasadena, California, United States
Christiana Care Health Services
Newark, Delaware, United States
Riverside Clinical Research
Edgewater, Florida, United States
...and 21 more locations
Time frame: Baseline, Days 1, 5, Follow-up (FU), and late Follow-up (LFU)
Microbiological Response Rate in All Subjects (Microbiological Evaluable Population)
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)
Microbiological Response Rate in Subjects With MRSA (Methicillin Resistant Staphylococcus Aureus) in Microbiological Evaluable (ME) Population
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)
Clinical Response in Subjects With Infections Caused by MRSA - Microbiological ITT (MITT) Population
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)