CompletedPhase 3

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

United States667 participantsStarted 2010-08-15

Plain-language 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

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 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

What they're measuring

Early Clinical Response Rate

Timeframe: 48-72 hours

Trial details

NCT IDNCT01170221

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

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2011-09-30

Results submitted2014-07-15

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