Efficacy and Safety Study of JNJ-32729463 for Treating Complicated Skin and Skin Structure Infections Compared to Linezolid (Zyvox)

• Status: Completed
• Trial end date: 2011-01-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine the clinical efficacy, safety, and tolerability of a 250 mg BID oral dose of JNJ-32729463 compared with linezolid in subjects with complicated skin and skin structure infections (cSSSIs).

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

Details

• Lead Sponsor: Furiex Pharmaceuticals, Inc
• Treatments: Linezolid

Criteria

Inclusion Criteria:

• Clinical diagnosis of a complicated skin and skin structure infection (cSSSI) including wound infection, deep cellulitis or severe abscess

• Women of childbearing potential must agree to use an acceptable form of contraception

• Infection site offers ability to obtain a microbiological specimen

• Received only 1 dose of any potentially effective systemic antibiotic within 24 hours of beginning study treatment

Exclusion Criteria:

• History of hypersensitivity or allergic reaction to quinolones or to linezolid

• Female and pregnant or breastfeeding or may be pregnant

• Chronic or underlying skin condition surrounding the area of infection that may complicate the assessment of response (e.g. atopic dermatitis, eczema, or psoriasis)

• Subject has infections with a high cure rate after surgical incision alone after aggressive local skin care

• Subject has infection(s) suspected to be caused by Gram-negative rods, anaerobic bacteria or unusual pathogens

• Subject has an infection that is expected to require other antifungal, antimycobacterial, or antibacterial agents in addition to study medication

Other protocol-specific eligibility criteria may apply