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

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Trial Summary
Trial Overview
Inclusion Criteria

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
12
sites
Trius Study Site #009
Long Beach, California 92708
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Long Beach, CA
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Trius Study site #001
Chula Vista, California 91911
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mi
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Chula Vista, CA
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Trius Study site 004
Columbus, Georgia 31904
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mi
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Columbus, GA
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Trius study sie #008
Detroit, Michigan 48202
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mi
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Detroit, MI
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Trius Study Site #011
Dothan, Alabama 36301
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mi
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Dothan, AL
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Trius Study site #006
Ludowici, Georgia 31316
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mi
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Ludowici, GA
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Trius Study site #002
Oceanside, California 92056
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mi
from
Oceanside, CA
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Trius Study site #010
Pasadena, California 91105
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mi
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Pasadena, CA
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Trius Study site 007
San Francisco, California 94143
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mi
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San Francisco, CA
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Trius Study site 003
San Jose, California 95124
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mi
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San Jose, CA
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Trius Study site #005
Savannah, Georgia 31406
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mi
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Savannah, GA
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Trius Study site #012
Springfield, Illinois 62701
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mi
from
Springfield, IL
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