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
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
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. ;
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