CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 735 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.

Search/NCT02877927
NCT02877927Phase 3Completed

A Phase 3 Randomized, Double-Blind, Multi-Center Study to Compare the Safety and Efficacy of Oral Omadacycline to Oral Linezolid for Treating Adult Subjects With Acute Bacterial Skin and Skin Structure Infection (ABSSSI)

Paratek Pharmaceuticals Inc·interventional·Posted Aug 24, 2016·Updated Nov 30, 2018

In Brief

A Phase 3 clinical trial evaluating Omadacycline and Linezolid for Bacterial Infections and Skin Structures and Soft Tissue Infections. Completed, enrolled 735 participants across 50 sites.

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--
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedAug 24, 2016
Enrollment StartAug 1, 2016
Primary CompletionMay 26, 2017
Study CompletionJun 6, 2017
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 9.9 years ago

Interventions

Omadacyclinedrug

po tablets

Linezoliddrug

po tablets