TR-701 FA vs Linezolid for the Treatment of Acute Bacterial Skin and Skin Structure Infections
- Conditions
- Skin and Subcutaneous Tissue Bacterial Infections
- Interventions
- Registration Number
- NCT01421511
- Lead Sponsor
- Trius Therapeutics LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
- 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 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.
- 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 linezolid treatment at 48-72 hours after the first infusion of study drug in the intent-to-treat (ITT) analysis set in patients with acute bacterial skin and skin structure infections (ABSSSI).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 666
- Patients requiring IV antibiotic therapy and with systemic signs of infection diagnosed with ABSSSI.
- Diagnosed with Cellulitis/ erysipelas, major cutaneous abscess, or wound infections
- Uncomplicated skin infections
- Severe sepsis or septic shock
- ABSSSI solely due to gram-negative pathogens
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Linezolid Linezolid • Linezolid IV followed by Linezolid Tablets TR-701 FA TR-701 FA • TR-701 FA IV followed by TR-701 FA tablets
- Primary Outcome Measures
Name Time Method The Early Clinical Response Rate 48-72 hours Responder: No increase in lesion surface area from baseline.
- Secondary Outcome Measures
Name Time Method Investigator's Assessment of Clinical Success of the Post Therapy Evaluation Visit in Clinically Evaluable-Post Treatment Evaluation Analysis Set. Post-Treatment Evaluation (7-14 days after the End of Therapy) Clinical success defined as resolution/near resolution of disease specific signs and symptoms, absence/near resolution of baseline systemic signs of infection, no new signs, symptoms or complications attributable to the ABSSSI and no further antibiotic therapy required for treatment of primary ABSSSI lesion.
Clinical Response at the End of Therapy Visit in the Clinically Evaluable at End of Therapy Analysis Set End of Therapy Day 11 Responder: No increase in lesion surface area from baseline.
Investigator's Assessment of Clinical Success at the Post Treatment Evaluation Visit Post-Treatment Evaluation (7-14 days after the End of Therapy) Clinical success defined as resolution/near resolution of disease specific signs and symptoms, absence/near resolution of baseline systemic signs of infection, and no further antibiotic therapy required for treatment of primary ABSSSI lesion.
Change From Baseline in Patient-reported Pain, by Study Visit Multiple 0=no pain, 10=worst pain Only 1 visit per participant for Day 4-6, only 1 visit for Day 7-9, and only 1 visit for Day 10-13.
Investigator's Assessment of Clinical Response at the 48-72 Hour Visit 48-72 Hours Clinical improvement defined as improvement in overall clinical status.
Investigator's Assessment of Clinical Response at the Day-7 Visit Day 7 Clinical improvement defined as improvement in overall clinical status.
Clinical Response at the End of Therapy Visit Day 11 Responder: No increase in lesion surface area from baseline.
Related Research Topics
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Trial Locations
- Locations (111)
Trius investigator site 159
🇺🇸Dothan, Alabama, United States
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
Scroll for more (101 remaining)Trius investigator site 159🇺🇸Dothan, Alabama, United States