Phase 3
N=666
TR-701 FA vs Linezolid for the Treatment of Acute Bacterial Skin and Skin Structure Infections
Skin and Subcutaneous Tissue Bacterial Infections
Bottom Line
View on ClinicalTrials.gov: NCT01421511 ↗Enrolled (actual)
666
Serious AEs
2.4%
Results posted
Sep 2014
Primary outcome: Primary: The Early Clinical Response Rate — 283; 276 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- TR-701 FA (Drug); Linezolid (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Trius Therapeutics LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
- Primary completion
- Jan 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Early Clinical Response Rate |
283; 276 | — |
| SECONDARY Clinical Response at the End of Therapy Visit |
289; 294 | — |
| SECONDARY Clinical Response at the End of Therapy Visit in the Clinically Evaluable at End of Therapy Analysis Set |
272; 280 | — |
| SECONDARY Investigator's Assessment of Clinical Success at the Post Treatment Evaluation Visit |
292; 293 | — |
| SECONDARY Investigator's Assessment of Clinical Success of the Post Therapy Evaluation Visit in Clinically Evaluable-Post Treatment Evaluation Analysis Set. |
268; 269 | — |
| SECONDARY Investigator's Assessment of Clinical Response at the 48-72 Hour Visit |
304; 302 | — |
| SECONDARY Investigator's Assessment of Clinical Response at the Day-7 Visit |
309; 308 | — |
| SECONDARY Change From Baseline in Patient-reported Pain, by Study Visit |
-1.7; -2.1; -3.1; -3.3; -4.9; -4.9 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01421511). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.