NCT01421511

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 IV to Oral 6-Day TR-701 Free Acid and IV to Oral 10-Day Linezolid for the Treatment of ABSSSI

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 666 (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, global Phase 3 study of IV to oral TR-701 FA 200 mg once daily for 6 days versus IV to oral Zyvox® (linezolid) 600 mg every 12 hours for 10 days for the treatment of ABSSSI in adults. Patients are to start treatment with at least 2 IV doses and may receive IV therapy for the entire treatment duration. Approximately 100 to 140 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 (NI) in the early clinical response rate of intravenous (IV) to oral 6 day TR-701 free acid (FA) compared with that of IV to oral 10-day linezolid treatment at 48-72 hours after the first infusion of study drug in the intent-to-treat (ITT) analysis set in patients with acute bacterial skin and skin structure infections (ABSSSI).

Conditions

• Skin and Subcutaneous Tissue Bacterial Infections

Interventions

Type	Name	Description
DRUG	TR-701 FA	* TR-701 FA 200 mg once daily in 250 mL sterile saline for injection as a 60 minute IV infusion * TR-701 FA Tablets, 200 mg, orally once daily
DRUG	Linezolid	* Linezolid 600 mg IV Injection twice daily in 300 mL sterile saline for injection as a 60 minute IV infusion * Linezolid Tablets, 600 mg, orally every 12 hours

Timeline

• Start date: 2011-09-15
• Primary completion: 2013-01-10
• Completion: 2013-01-10
• First posted: 2011-08-22
• Last updated: 2018-08-29
• Results posted: 2014-09-08

Locations

117 sites across 11 countries: United States, Argentina, Australia, Brazil, Germany, Mexico, New Zealand, Poland, Russia, South Africa, Spain