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.

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

Skin Diseases, Infectious

Skin Diseases, Bacterial

TR-701 200 mg

TR-701 300 mg

TR-701 400 mg

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

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.

Satisfactory microbiological outcomes are eradication and presumed eradication

Persistent clinical cure was defined as continuing favorable response.

Trius Study Site #011

Trius Study site #001

Trius Study Site #009

Trius Study site #002

Trius Study site #010

Trius Study site 007

Trius Study site 003

Trius Study site 004

Trius Study site #006

Trius Study site #005

Trius Study site #012

Trius study sie #008

Oral TR-701 200 mg once daily for 5 to 7 days

Oral TR-701 300 mg once daily for 5 to 7 days

Oral TR-701 400 mg once daily for 5 to 7 days

Total

Age, Continuous

Sex: Female, Male

All randomized participants who received study drug.

Philippe Prokocimer, MD

The Clinically Evaluable analysis set includes data from all participants who had a diagnosis of cSSSI, received minimal study therapy, completed an assessment, and had no confounding events or factors.

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

The clinically modified intent to treat analysis set includes data from all participants who received study drug and had a diagnosis of complicated skin and skin structure infection.

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

The clinical modified intent to treat analysis set includes data from all participants who received study drug and had a diagnosis of complicated skin and skin structure infection

Response Rate at End of Therapy

The microbiologically evaluable analysis set includes all participants who received study drug, had a diagnosis of complicated skin and skin structure infection, completed an assessment, had no confounding events or factors, and had a baseline Gram-positive bacterial pathogen.

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

The clinical modified intent to treat analysis set includes data from all participants who received study drug and had a diagnosis of complicated skin and skin structure infection. Microbiological samples not available from all participants.

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

About this trial

Study ID

Status

Type

Phase

Placebo

Accepting

Trial Timing

What is this trial about?

What are the participation requirements?