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, 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 ...
Detailed Description
The primary objective is to determine the noninferiority (NI) in the early clinical response rate of intravenous (IV) to oral 6 day TR-701 free acid (FA) compared with that of IV to oral 10-day linezo...
Eligibility Criteria
Inclusion
- 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
- Uncomplicated skin infections
- Severe sepsis or septic shock
- ABSSSI solely due to gram-negative pathogens
Key Trial Info
Start Date :
September 15 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 10 2013
Estimated Enrollment :
666 Patients enrolled
Trial Details
Trial ID
NCT01421511
Start Date
September 15 2011
End Date
January 10 2013
Last Update
August 29 2018
Active Locations (117)
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1
Trius investigator site 159
Dothan, Alabama, United States, 36305
2
Trius investigator site 103
Chula Vista, California, United States, 91911
3
Trius investigator site 143
Escondido, California, United States, 92025
4
Trius investigator site 105
La Mesa, California, United States, 91942