Phase 2
N=192
Phase 2 Study of TR-701 in Patients With Complicated Skin and Skin Structure Infections
Skin Diseases, Infectious · Skin Diseases, Bacterial
Bottom Line
View on ClinicalTrials.gov: NCT00761215 ↗Enrolled (actual)
192
Serious AEs
2.7%
Results posted
Aug 2014
Primary outcome: Primary: Clinical Response Rate at Test of Cure in the Clinically Evaluable Analysis Set — 98.2; 94.4; 94.4 Percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- TR-701 200 mg (Drug); TR-701 300 mg (Drug); TR-701 400 mg (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
- Feb 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Clinical Response Rate at Test of Cure in the Clinically Evaluable Analysis Set |
98.2; 94.4; 94.4 | — |
| PRIMARY Clinical Response Rate at Test of Cure in the Clinical Modified Intent to Treat Analysis Set |
88.9; 88.9; 85.5 | — |
| SECONDARY Response Rate at End of Therapy |
93.7; 90.5; 91.9 | — |
| SECONDARY Microbiological Response Rate at Test of Cure in the Microbiologically Evaluable Analysis Set |
100; 93.2; 100 | — |
| SECONDARY Clinical Outcome at the Late Follow-up Visit in the Clinical Modified Intent to Treat Analysis Set |
96.4; 98.2; 98.1 | — |
| SECONDARY To Evaluate the Safety Profile of Tedizolid Phosphate |
— | — |
| SECONDARY Population PK |
— | — |
| SECONDARY Microbiological Recurrence at Late Follow-up in Clinical Modified Intent to Treat Analysis Set |
0; 0; 0 | — |
Summary
The purpose of the study is to determine the oral dosage of TR-701 to be used in Phase III studies in patients with complicated skin and skin structure infections.
Eligibility Criteria
Inclusion Criteria
- Diagnosed with complicated skin and skin structure infection with at least 2 signs and symptoms
- Suspected or confirmed infection due to a gram-positive organism
Exclusion Criteria
- Complicated skin and skin structure infection due to gram-negative organisms
- Complicated skin and skin structure infections requiring more than 7 days of therapy
- Uncontrolled diabetes
- Chronic systemic immunosuppressive therapy
- AIDS with CD4 count < 200 cells/mm3
- Uncontrolled hypertension
- Mild moderate or severe renal failure
- Severe hepatic disease
- Neutropenia
- Use of antidepressants such as SSRIs or MAOIs for 14 days before first dose of study drug
- Women who are pregnant or nursing
Data sourced from ClinicalTrials.gov (NCT00761215). 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.