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

• Status: Completed
• Trial end date: 2013-01-10
• Target enrollment: 0
• Participant gender: All

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.

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

Details

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

Criteria

Inclusion Criteria:

• Patients requiring IV antibiotic therapy and with systemic signs of infection diagnosed with 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