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

Completed · Phase 2 · Has a placebo group

Conditions studied: Complicated Skin and Skin Structure Infections

In brief

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).

Key facts

Study ID

NCT01128530

Run by

Furiex Pharmaceuticals, Inc

People needed

161

Starts

2010-06-01

Expected to finish

2011-01-01

Last updated by the study team

2011-12-16

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Furiex Research Site — Anaheim, California, United States
• Furiex Research Site — Buena Park, California, United States
• Furiex Research Site — Chula Vista, California, United States
• Furiex Research Site — Fountain Valley, California, United States
• Furiex Research Site — La Mesa, California, United States
• Furiex Research Site — Long Beach, California, United States
• Furiex Research Site — Oceanside, California, United States
• Furiex Research Site — Santa Ana, California, United States
• Furiex Research Site — Fort Myers, Florida, United States
• Furiex Research Site — Kissimmee, Florida, United States
• Furiex Research Site — Saint Cloud, Florida, United States
• Furiex Research Site — Columbus, Georgia, United States
• Furiex Research Site — Savannah, Georgia, United States
• Furiex Research Site — Idaho Falls, Idaho, United States
• Furiex Research Site — Libertyville, Illinois, United States
• Furiex Research Site — Baton Rouge, Louisiana, United States
• Furiex Research Site — New Orleans, Louisiana, United States
• Furiex Research Site — Sulphur, Louisiana, United States
• Furiex Research Site — Detroit, Michigan, United States
• Furiex Research Site — Keego Harbor, Michigan, United States
• Furiex Research Site — Butte, Montana, United States
• Furiex Research Site — Toledo, Ohio, United States
• Furiex Research Site — Philadelphia, Pennsylvania, United States
• Furiex Research Site — Houston, Texas, United States
• Furiex Research Site — Houston, Texas, United States

Full record on ClinicalTrials.gov

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