Phase 2 Study of TR-701 in Patients With Complicated Skin and Skin Structure Infections
- Conditions
- Skin Diseases, InfectiousSkin Diseases, Bacterial
- Interventions
- Drug: TR-701 400 mgDrug: TR-701 300 mgDrug: TR-701 200 mg
- Registration Number
- NCT00761215
- Lead Sponsor
- Trius Therapeutics LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 192
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description TR-701 400 mg TR-701 400 mg - TR-701 300 mg TR-701 300 mg - TR-701 200 mg TR-701 200 mg -
- Primary Outcome Measures
Name Time Method Clinical Response Rate at Test of Cure in the Clinically Evaluable Analysis Set 7 to 14 days after the last dose of study drug Clinical response was defined as resolution or improvement of signs and symptoms of the complicated skin and skin structure infection so that no further antibiotic therapy was required.
Clinical Response Rate at Test of Cure in the Clinical Modified Intent to Treat Analysis Set 7-14 days after last dose of study drug Clinical response was defined as resolution or improvement of signs and symptoms of the complicated skin and skin structure infection so that no further antibiotic therapy was required.
- Secondary Outcome Measures
Name Time Method Microbiological Response Rate at Test of Cure in the Microbiologically Evaluable Analysis Set 7-14 days after last dose of study drug Satisfactory microbiological outcomes are eradication and presumed eradication
Microbiological Recurrence at Late Follow-up in Clinical Modified Intent to Treat Analysis Set 21-28 days after last study drug Population PK Multiple Response Rate at End of Therapy last day of study treatment Clinical response was defined as resolution or improvement of signs and symptoms of the complicated skin and skin structure infection so that no further antibiotic therapy was required.
Clinical Outcome at the Late Follow-up Visit in the Clinical Modified Intent to Treat Analysis Set 21 to 28 days after the last study drug Persistent clinical cure was defined as continuing favorable response.
To Evaluate the Safety Profile of Tedizolid Phosphate Multiple
Trial Locations
- Locations (12)
Trius study sie #008
🇺🇸Detroit, Michigan, United States
Trius Study Site #009
🇺🇸Long Beach, California, United States
Trius Study Site #011
🇺🇸Dothan, Alabama, United States
Trius Study site #001
🇺🇸Chula Vista, California, United States
Trius Study site 003
🇺🇸San Jose, California, United States
Trius Study site 007
🇺🇸San Francisco, California, United States
Trius Study site #002
🇺🇸Oceanside, California, United States
Trius Study site #010
🇺🇸Pasadena, California, United States
Trius Study site 004
🇺🇸Columbus, Georgia, United States
Trius Study site #005
🇺🇸Savannah, Georgia, United States
Trius Study site #006
🇺🇸Ludowici, Georgia, United States
Trius Study site #012
🇺🇸Springfield, Illinois, United States