Status:
COMPLETED
Phase 2 Study of TR-701 in Patients With Complicated Skin and Skin Structure Infections
Lead Sponsor:
Trius Therapeutics LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Conditions:
Skin Diseases, Infectious
Skin Diseases, Bacterial
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 17 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 24 2009
Estimated Enrollment :
192 Patients enrolled
Trial Details
Trial ID
NCT00761215
Start Date
September 17 2008
End Date
February 24 2009
Last Update
November 25 2019
Active Locations (12)
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1
Trius Study Site #011
Dothan, Alabama, United States, 36301
2
Trius Study site #001
Chula Vista, California, United States, 91911
3
Trius Study Site #009
Long Beach, California, United States, 92708
4
Trius Study site #002
Oceanside, California, United States, 92056