At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 655 enrolled
Drug / intervention
Omadacycline +1 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 Randomized, Double-blind, Multi-center Study to Compare the Safety and Efficacy of Omadacycline IV/PO to Linezolid IV/PO for Treating Adults With Acute Bacterial Skin and Skin Structure Infections (ABSSSI)
In Brief
A Phase 3 clinical trial evaluating Omadacycline and Linezolid for Bacterial Infections and Skin Structures and Soft Tissue Infections. Completed, enrolled 655 participants across 78 sites in 14 countries.
Detailed Summary
The purpose of this study is to evaluate the safety and efficacy of omadacycline as compared to linezolid in the treatment of adults with acute bacterial skin and skin structure infections.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesBulgaria, Croatia, Greece, Hungary, Israel, Latvia, Peru, Poland, Romania, South Africa, Spain, Turkey (Türkiye), Ukraine, United States
Collaborators--
Timeline
Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedMar 2015
Enrollment StartJun 2015
Primary CompletionApr 2016
Study CompletionMay 2016
TodayJul 2026
First PostedMar 4, 2015
Enrollment StartJun 1, 2015
Primary CompletionApr 1, 2016
Study CompletionMay 1, 2016
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 11.3 years ago
Interventions
Omadacyclinedrug
Injection for IV dosing; Tablets for oral dosing
Linezoliddrug
Infusion solution for IV dosing; Tablets for oral dosing