Conditions: Skin and Subcutaneous Tissue Bacterial Infections
Keywords: ABSSSI Tedizolid Phosphate TR-701 Acute Bacterial Skin and Skin Structure Infections
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 666
Healthy volunteers: no

Brief 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.

Detailed description:
The primary objective is to determine the noninferiority (NI) in the early clinical response rate of intravenous (IV) to oral 6 day TR-701 free acid (FA) compared with that of IV to oral 10-day linezolid treatment at 48-72 hours after the first infusion of study drug in the intent-to-treat (ITT) analysis set in patients with acute bacterial skin and skin structure infections (ABSSSI).

Arms:
arm 1: • TR-701 FA IV followed by TR-701 FA tablets arm 2: • Linezolid IV followed by Linezolid Tablets

Interventions: intervention 1: TR-701 FA intervention 2: Linezolid
Intervention descriptions: intervention 1: * TR-701 FA 200 mg once daily in 250 mL sterile saline for injection as a 60 minute IV infusion
* TR-701 FA Tablets, 200 mg, orally once daily intervention 2: * Linezolid 600 mg IV Injection twice daily in 300 mL sterile saline for injection as a 60 minute IV infusion
* Linezolid Tablets, 600 mg, orally every 12 hours

Protocol document: