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)

Status and phase: Completed; Phase 2

Conditions: Skin Diseases, Infectious; Skin Diseases, Bacterial

Treatments: Drug: TR-701 200 mg; Drug: TR-701 300 mg; Drug: TR-701 400 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT00761215

1986-007

TR701-104 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 192 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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192 participants in 3 patient groups

TR-701 200 mg

Experimental group

Treatment:

Drug: TR-701 200 mg

TR-701 300 mg

Experimental group

Treatment:

Drug: TR-701 300 mg

TR-701 400 mg

Experimental group

Treatment:

Drug: TR-701 400 mg