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

• Status: Completed
• Trial end date: 2012-08-27
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Trius Therapeutics LLC
• Collaborator: Bayer
• Treatments: Tedizolid; Torezolid phosphate

Criteria

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