A Phase 2 Safety and Exploratory Skin Lesion Measurement of TR-701 FA Study

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

Status and phase: Completed; Phase 2

Conditions: Cellulitis; Major Cutaneous Abscess; Erysipelas

Treatments: Drug: TR701 FA

Study type: Interventional

Funder types: Industry

Identifiers

NCT01519778

1986-011

TR701-126 (Other Identifier)

Details and patient eligibility

About

Characterization of the safety profile of TR-701 Free Acid (FA) in patients with major cutaneous abscess or cellulitis/erysipelas.

Full description

This is an open-label, multicenter study of oral TR-701 FA 200 mg once daily for 6 days for the treatment of major cutaneous abscess or cellulitis/erysipelas in patients 18 years of age or older. This study is designed to further characterize the safety profile and gather additional lesion measurement data of TR-701 FA in patients with major cutaneous abscess or cellulitis/erysipelas.

Enrollment: 200 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female patients ≥ 18 years of age
• Suspected or documented gram-positive infection from baseline Gram stain or culture.
• Cellulitis/erysipelas or major cutaneous abscesses at Screening

Exclusion criteria

• Postsurgical or open wound infections
• Severe sepsis or septic shock
• Uncomplicated skin and skin structure infections such as furuncles, minor abscesses (< 75 cm2 or area of suppuration not surrounded by cellulitis/erythema), and impetiginous lesions
• Infections associated with, or in close proximity to, a prosthetic device
• Known bacteremia or osteomyelitis at time of screening

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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200 participants in 1 patient group

TR-701 FA

Experimental group

Treatment:

Drug: TR701 FA