Phase 3
N=667
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: NCT01170221 ↗Enrolled (actual)
667
Serious AEs
1.4%
Results posted
Sep 2014
Primary outcome: Primary: Early Clinical Response Rate — 264; 266 Responders
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
- Sep 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Early Clinical Response Rate |
264; 266 | — |
| SECONDARY Clinical Response at 48-72 Hours That is Sustained at the End of Therapy Visit. |
230; 241 | — |
| SECONDARY Clinical Response at 48-72 Hours That is Sustained at the End of Therapy Visit in the Clinically Evaluable-End of Therapy Analysis Sets |
219; 232 | — |
| SECONDARY Investigator's Assessment of Clinical Success at the Post Treatment Evaluation Visit |
284; 288 | — |
| SECONDARY To Compare the Investigator's Assessment of Clinical Success at the Post Treatment Evaluation Visit in the Clinically Evaluable-Post Treatment Evaluation Analysis Set |
264; 267 | — |
| SECONDARY Investigator's Assessment of Clinical Response at the 48-72 Hour Visit |
299; 290 | — |
| SECONDARY Investigator's Assessment of Clinical Response at the Day 7 Visit |
302; 299 | — |
| SECONDARY Change From Baseline in Patient-reported Pain, by Study Visit |
-1.3; -1.5; -3.4; -3.1; -4.5; -4.6 | — |
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 treatment of ABSSSI in adults.
Approximately 75 to 100 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 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 Criteria
- Uncomplicated skin infections
- Severe sepsis or septic shock
- ABSSSI solely due to gram-negative pathogens
Data sourced from ClinicalTrials.gov (NCT01170221). 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.