TR-701 FA vs Linezolid for the Treatment of Acute Bacterial Skin and Skin Structure Infections
| Status: | Completed |
|---|---|
| Conditions: | Infectious Disease |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 8/31/2018 |
| Start Date: | September 15, 2011 |
| End Date: | January 10, 2013 |
A Phase 3 Randomized, Double-Blind, Multicenter Study Comparing the Efficacy and Safety of IV to Oral 6-Day TR-701 Free Acid and IV to Oral 10-Day Linezolid for the Treatment of ABSSSI
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.
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.
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).
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).
Inclusion Criteria:
- 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 Criteria:
- Uncomplicated skin infections
- Severe sepsis or septic shock
- ABSSSI solely due to gram-negative pathogens
We found this trial at
35
sites
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