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).
Minimum age: 18 Years.
Maximum age: 70 Years.
Gender(s): Both.
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
Furiex Research Site, Anaheim, California 92804, United States
Furiex Research Site, Buena Park, California 90620, United States
Furiex Research Site, Chula Vista, California 91911, United States
Furiex Research Site, Fountain Valley, California 92708, United States
Furiex Research Site, La Mesa, California 91942, United States
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Furiex Research Site, Houston, Texas 77005, United States
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