At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 660 enrolled
Drug / intervention
Delafloxacin +3 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 3, Multicenter, Randomized, Double-blind, Active-controlled Study to Evaluate the Efficacy and Safety of Delafloxacin Compared With Vancomycin + Aztreonam in Patients With Acute Bacterial Skin and Skin Structure Infections
In Brief
A Phase 3 clinical trial evaluating Delafloxacin, Vancomycin, and 2 other interventions for Skin and Subcutaneous Tissue Bacterial Infections. Completed, enrolled 660 participants across 50 sites in 7 countries.
Detailed Summary
This study was designed to evaluate the efficacy of delafloxacin patients with acute bacterial skin and soft tissue infections (ABSSSI).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCroatia, Israel, Latvia, Russia, Spain, Ukraine, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedMar 2013
Enrollment StartApr 2013
Primary CompletionJul 2014
TodayJul 2026
First PostedMar 15, 2013
Enrollment StartApr 1, 2013
Primary CompletionJul 1, 2014
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 13.3 years ago
Interventions
Delafloxacindrug
Delafloxacin
Vancomycindrug
Vancomycin
Aztreonamdrug
Aztreonam
Placebodrug
Placebo