Status:
COMPLETED
TR-701 FA vs. Linezolid for the Treatment of Acute Bacterial Skin and Skin Structure Infections.
Lead Sponsor:
Trius Therapeutics LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Conditions:
Skin and Subcutaneous Tissue Bacterial Infections
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 trea...
Detailed Description
The primary objective is to determine the noninferiority in the early clinical response rate of 6 day oral TR-701 FA compared with that of 10-day oral linezolid treatment at the 48-72 Hour Visit in th...
Eligibility Criteria
Inclusion
- 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
- Uncomplicated skin infections
- Severe sepsis or septic shock
- ABSSSI solely due to gram-negative pathogens
Key Trial Info
Start Date :
August 15 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 30 2011
Estimated Enrollment :
667 Patients enrolled
Trial Details
Trial ID
NCT01170221
Start Date
August 15 2010
End Date
September 30 2011
Last Update
August 29 2018
Active Locations (84)
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1
Trius investigator site 109
Dothan, Alabama, United States, 36301
2
Trius Investigator site 130
Anaheim, California, United States, 92801
3
Trius investigator site 118
Anaheim, California, United States, 92804
4
Trius investigator site 129
Buena Park, California, United States, 90620