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

Phase 2 Open-Label Safety and Exploratory Skin Lesion Measurement Study of 6-Day Oral TR-701 FA in Skin Abscess and Cellulitis Patients

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

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.

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