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

Completed · Phase 3 · Has a placebo group

Conditions studied: Skin and Subcutaneous Tissue Bacterial Infections

In brief

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

Key facts

Study ID

NCT01170221

Run by

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

People needed

667

Starts

2010-08-15

Expected to finish

2011-09-30

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 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

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 130 — Anaheim, California, United States
• Trius investigator site 118 — Anaheim, California, United States
• Trius investigator site 129 — Buena Park, California, United States
• Trius Investigator Site 103 — Chula Vista, California, United States
• Trius Investigator Site 105 — La Mesa, California, United States
• Trius investigator site 126 — Laguna Beach, California, United States
• Trius investigator site 125 — Norwalk, California, United States
• Trius Investigator Site 104 — Oceanside, California, United States
• Trius investigator site 113 — Oxnard, California, United States
• Trius investigator site 123 — Pasadena, California, United States
• Trius Investigator Site 106 — Rolling Hills Estates, California, United States
• Trius investigator site 111 — Torrance, California, United States
• Trius investigator site 132 — Torrance, California, United States
• Trius investigator site 127 — Fort Lauderdale, Florida, United States
• Trius investigator site 135 — Hialeah, Florida, United States
• Trius investigator site 101 — Columbus, Georgia, United States
• Trius Investigator Site 102 — Savannah, Georgia, United States
• Trius Investigator site 116 — Chicago, Illinois, United States
• Trius Investigator Site 108 — Springfield, Illinois, United States
• Trius investigator site 112 — Evansville, Indiana, United States
• Trius Investigator Site 107 — Detroit, Michigan, United States
• Trius investigator site 133 — Butte, Montana, United States
• Trius investigator site 128 — Las Vegas, Nevada, United States
• Trius investigator site 115 — Somers Point, New Jersey, United States
• Trius investigator site 109 — Dothan, Alabama, United States

Full record on ClinicalTrials.gov

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