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

• Status: Completed
• Trial end date: 2011-09-30
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Trius Therapeutics LLC
• Treatments: Linezolid; Tedizolid; Tedizolid phosphate; Torezolid; Torezolid phosphate

Criteria

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