Phase 2 Study of TR-701 in Patients With Complicated Skin and Skin Structure Infections

A Phase 2 Multi-Center, Randomized, Double-Blind, Non-Controlled Study Comparing the Safety, Tolerance, and Efficacy of TR-701 in Patients With Complicated Skin and Skin Structure Infections

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.

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