CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 667 enrolled
Drug / intervention
TR-701 FA +1 moredrug
Likely dose
TR-701 FA 200 mgfrom 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/NCT01170221
NCT01170221Phase 3Completed
CompareCT.gov

A Phase 3 Randomized, Double-Blind, Multicenter Study Comparing the Efficacy and Safety of 6-Day Oral TR-701 Free Acid and 10-Day Oral Linezolid for the Treatment of Acute Bacterial Skin and Skin Structure Infections

Trius Therapeutics LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)·interventional·Posted Jul 27, 2010·Updated Aug 29, 2018

In Brief

A Phase 3 clinical trial evaluating TR-701 FA and Linezolid for Skin and Subcutaneous Tissue Bacterial Infections. Completed, enrolled 667 participants across 84 sites in 11 countries.

Detailed Summary

This is a randomized, double-blind, double dummy, multicenter Phase 3 study of oral TR-701 FA 200 mg once daily for 6 days versus oral Zyvox® (linezolid) 600 mg every 12 hours for 10 days for the treatment of ABSSSI in adults. Approximately 75 to 100 sites globally will participate in this study. Patients with an ABSSSI caused by suspected or documented gram positive pathogen(s) at baseline will be randomized 1:1 to study treatment

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSkin and Subcutaneous Tissue Bacterial Infections
CountriesArgentina, Brazil, Canada, Czechia, Germany, Hungary, Latvia, Peru, Slovakia, Ukraine, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJul 27, 2010
Enrollment StartAug 15, 2010
Primary CompletionSep 30, 2011
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 15.9 years ago

Interventions

TR-701 FAdrug

Oral TR-701 FA 200 mg once daily for six days followed by four days of placebo.

Linezoliddrug

Oral Linezolid 600 mg twice daily for 10 days