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COMPLETEDPhase 2NCT00761215

Phase 2 Study 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.

Lead sponsor: Trius Therapeutics LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)•12 U.S. locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

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

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

No

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

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: November 25, 2019Terms

Trial snapshot

StatusCOMPLETED

PhasePHASE2

Enrollment192

Start dateSep 2008

Last updatedNov 25, 2019

Condition

Skin Diseases, Infectious Skin Diseases, Bacterial

Locations shown

Trius Study Site #011

Dothan, Alabama

Trius Study site #001

Chula Vista, California

Trius Study Site #009

Long Beach, California

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 25, 2019Data synced to Clareo: May 25, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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