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

Completed · Phase 3

Conditions studied: Skin and Subcutaneous Tissue Bacterial Infections

In brief

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.

Key facts

Study ID

NCT01421511

Run by

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

People needed

666

Starts

2011-09-15

Expected to finish

2013-01-10

Last updated by the study team

2018-08-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients requiring IV antibiotic therapy and with systemic signs of infection diagnosed with ABSSSI.
• Diagnosed with Cellulitis/ erysipelas, major cutaneous abscess, or wound infections

You may not qualify if…

• Uncomplicated skin infections
• Severe sepsis or septic shock
• ABSSSI solely due to gram-negative pathogens

Where it is running

• Trius investigator site 103 — Chula Vista, California, United States
• Trius investigator site 143 — Escondido, California, United States
• Trius investigator site 105 — La Mesa, California, United States
• Trius investigator site 106 — Long Beach, California, United States
• Trius investigator site 157 — Long Beach, California, United States
• Trius investigator site 142 — National City, California, United States
• Trius investigator site 170 — San Diego, California, United States
• Trius investigator site 167 — Santa Ana, California, United States
• Trius investigator site 168 — Stockton, California, United States
• Trius investigator site 141 — Sylmar, California, United States
• Trius investigator site 139 — Denver, Colorado, United States
• Trius investigator site 137 — Newark, Delaware, United States
• Trius investigator site 166 — Edgewater, Florida, United States
• Trius investigator site 101 — Columbus, Georgia, United States
• Trius investigator site 138 — Carmel, Indiana, United States
• Trius investigator site 144 — Owensboro, Kentucky, United States
• Trius investigator site 150 — Baton Rouge, Louisiana, United States
• Trius investigator site 165 — Eunice, Louisiana, United States
• Trius investigator site 154 — Boston, Massachusetts, United States
• Trius investigator site 146 — Springfield, Massachusetts, United States
• Trius investigator site 136 — West Roxbury, Massachusetts, United States
• Trius investigator site 163 — Royal Oak, Michigan, United States
• Trius investigator site 153 — Minneapolis, Minnesota, United States
• Trius investigator site 149 — Picayune, Mississippi, United States
• Trius investigator site 159 — Dothan, Alabama, United States

Full record on ClinicalTrials.gov

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