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

Completed · Phase 2

Conditions studied: Skin Diseases, Infectious, Skin Diseases, Bacterial

In brief

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.

Key facts

Study ID

NCT00761215

Run by

Trius Therapeutics LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

People needed

192

Starts

2008-09-17

Expected to finish

2009-02-24

Last updated by the study team

2019-11-25

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Trius Study Site #011 — Dothan, Alabama, United States
• Trius Study site #001 — Chula Vista, California, United States
• Trius Study Site #009 — Long Beach, California, United States
• Trius Study site #002 — Oceanside, California, United States
• Trius Study site #010 — Pasadena, California, United States
• Trius Study site 007 — San Francisco, California, United States
• Trius Study site 003 — San Jose, California, United States
• Trius Study site 004 — Columbus, Georgia, United States
• Trius Study site #006 — Ludowici, Georgia, United States
• Trius Study site #005 — Savannah, Georgia, United States
• Trius Study site #012 — Springfield, Illinois, United States
• Trius study sie #008 — Detroit, Michigan, United States

Full record on ClinicalTrials.gov

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