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

Status:	Completed
Conditions:	Skin and Soft Tissue Infections, Infectious Disease, Infectious Disease
Therapuetic Areas:	Dermatology / Plastic Surgery, Immunology / Infectious Diseases
Healthy:	No
Age Range:	18 - Any
Updated:	8/31/2018
Start Date:	August 15, 2010
End Date:	September 30, 2011

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.

Inclusion Criteria:

- Patients with systemic signs of infection diagnosed with acute bacterial skin and skin
structure infection (ABSSSI)

- Diagnosed with Cellulitis/ erysipelas, major cutaneous abscess, or wound infections

Exclusion Criteria:

- Uncomplicated skin infections

- Severe sepsis or septic shock

- ABSSSI solely due to gram-negative pathogens

We found this trial at

sites

Trius investigator site 125

Norwalk, California 90650

from

Norwalk, CA