CompletedPhase 3

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

United States666 participantsStarted 2011-09-15

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

The Early Clinical Response Rate

Timeframe: 48-72 hours

Trial details

NCT IDNCT01421511

SponsorTrius Therapeutics LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2013-01-10

Results submitted2014-07-15

View on ClinicalTrials.gov More Skin and Subcutaneous Tissue Bacterial Infections trials