NCT01170221

TR-701 FA vs. Linezolid for the Treatment of Acute Bacterial Skin and Skin Structure Infections.

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 667 (actual)
• Sponsor: Trius Therapeutics LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed description

The primary objective is to determine the noninferiority in the early clinical response rate of 6 day oral TR-701 FA compared with that of 10-day oral linezolid treatment at the 48-72 Hour Visit in the ITT analysis set in patients with ABSSSI.

Conditions

• Skin and Subcutaneous Tissue Bacterial Infections

Interventions

Type	Name	Description
DRUG	TR-701 FA	Oral TR-701 FA 200 mg once daily for six days followed by four days of placebo.
DRUG	Linezolid	Oral Linezolid 600 mg twice daily for 10 days

Timeline

• Start date: 2010-08-15
• Primary completion: 2011-09-30
• Completion: 2011-09-30
• First posted: 2010-07-27
• Last updated: 2018-08-29
• Results posted: 2014-09-03

Locations

84 sites across 11 countries: United States, Argentina, Brazil, Canada, Czechia, Germany, Hungary, Latvia, Peru, Slovakia, Ukraine