At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 850 enrolled
Drug / intervention
delafloxacin +2 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 + Safety of IV + Oral Delafloxacin Compared With Vancomycin + Aztreonam in Patients With Acute Bacterial Skin and Skin Structure Infections (ABSSSI)
In Brief
A Phase 3 clinical trial evaluating delafloxacin, vancomycin, and 1 other intervention for Skin and Subcutaneous Tissue Bacterial Infections and Skin Structures and Soft Tissue Infections. Completed, enrolled 850 participants across 94 sites in 16 countries.
Detailed Summary
The purpose of this study is to evaluate the effects of Delafloxacin versus Vancomycin plus Aztreonam in the treatment of patients with acute bacterial skin and soft tissue infections.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSkin and Subcutaneous Tissue Bacterial Infections, Skin Structures and Soft Tissue Infections
CountriesArgentina, Brazil, Bulgaria, Chile, Estonia, Georgia, Hungary, Latvia, Mexico, Moldova, Peru, Romania, Slovakia, South Korea, Taiwan, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedNov 2013
Enrollment StartMay 2014
Primary CompletionDec 2015
Study CompletionJan 2016
TodayJul 2026
First PostedNov 15, 2013
Enrollment StartMay 1, 2014
Primary CompletionDec 1, 2015
Study CompletionJan 1, 2016
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 12.6 years ago
Interventions
delafloxacindrug
vancomycindrug
aztreonamdrug