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

Status:	Completed
Conditions:	Skin Cancer, Skin and Soft Tissue Infections, Infectious Disease
Therapuetic Areas:	Dermatology / Plastic Surgery, Immunology / Infectious Diseases, Oncology
Healthy:	No
Age Range:	18 - 75
Updated:	8/31/2018
Start Date:	September 17, 2008
End Date:	February 24, 2009

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

We found this trial at

sites

Trius Study site 004

Columbus, Georgia 31904

from

Columbus, GA