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

Skin and Subcutaneous Tissue Bacterial Infections Clinical Trial

Official title:
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

Clinical Trial 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

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Bacterial Infections
Communicable Diseases
Infection
Skin and Subcutaneous Tissue Bacterial Infections

Clinical Trial Details

NCT number	NCT01170221
Study type	Interventional
Source	Trius Therapeutics LLC
Contact
Status	Completed
Phase	Phase 3
Start date	August 15, 2010
Completion date	September 30, 2011

View Details

See also
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