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

• Status: Completed
• Trial end date: 2009-02-24
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Trius Therapeutics LLC
• Treatments: Tedizolid phosphate; Torezolid phosphate

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