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Clinical Trial 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.


Clinical Trial 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). ;


Study Design


Related Conditions & MeSH terms


NCT number NCT01421511
Study type Interventional
Source Trius Therapeutics LLC
Contact
Status Completed
Phase Phase 3
Start date September 15, 2011
Completion date January 10, 2013

See also
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Completed NCT02796716 - Study of Accuracy of New Diagnostic Technology to Guide Rapid Antibiotic Treatment for Serious Infections N/A
Completed NCT01283581 - A Study to Assess Objective Endpoint Measurements of Response in Bacterial Skin Infections Phase 2
Completed NCT01519492 - A Study of Safety, Tolerability, and Efficacy of AFN-12520000 in the Treatment of Acute Bacterial Skin and Skin Structure Infections Due to Staphylococci Phase 2
Completed NCT02060513 - Study of Accuracy of New Diagnostic Technology to Determine Guide Rapid Antibiotic Treatment for Serious Infections N/A
Completed NCT01170221 - TR-701 FA vs. Linezolid for the Treatment of Acute Bacterial Skin and Skin Structure Infections. Phase 3
Completed NCT01811732 - Delafloxacin Versus Vancomycin and Aztreonam for the Treatment of Acute Bacterial Skin and Skin Structure Infections Phase 3
Completed NCT03964493 - TNP-2092 to Treat Acute Bacterial Skin and Skin Structure Infection Phase 2