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

Trius Therapeutics LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)192 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

192

Conditions

Skin Diseases, Infectious Skin Diseases, Bacterial

Interventions

TR-701 200 mgDRUG

oral TR-701 200 mg for 5 to 7 days

TR-701 300 mgDRUG

oral TR-701 300 mg for 5 to 7 days

TR-701 400 mgDRUG

TR-701 400 mg for 5 to 7 days

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (12)

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

Outcomes

Primary Outcomes

Clinical Response Rate at Test of Cure in the Clinically Evaluable Analysis Set

Clinical response was defined as resolution or improvement of signs and symptoms of the complicated skin and skin structure infection so that no further antibiotic therapy was required.

Time frame: 7 to 14 days after the last dose of study drug

Clinical Response Rate at Test of Cure in the Clinical Modified Intent to Treat Analysis Set

Clinical response was defined as resolution or improvement of signs and symptoms of the complicated skin and skin structure infection so that no further antibiotic therapy was required.

Time frame: 7-14 days after last dose of study drug

Secondary Outcomes

Response Rate at End of Therapy

Clinical response was defined as resolution or improvement of signs and symptoms of the complicated skin and skin structure infection so that no further antibiotic therapy was required.

Time frame: last day of study treatment

Microbiological Response Rate at Test of Cure in the Microbiologically Evaluable Analysis Set

Satisfactory microbiological outcomes are eradication and presumed eradication

Time frame: 7-14 days after last dose of study drug

Clinical Outcome at the Late Follow-up Visit in the Clinical Modified Intent to Treat Analysis Set

Persistent clinical cure was defined as continuing favorable response.

Time frame: 21 to 28 days after the last study drug

To Evaluate the Safety Profile of Tedizolid Phosphate

Time frame: Multiple

Population PK

Data from ClinicalTrials.gov

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