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

Furiex Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Complicated Skin and Skin Structure Infections

Treatments: Drug: linezolid placebo; Drug: JNJ-32729463 placebo; Drug: linezolid; Drug: JNJ-32729463

Study type: Interventional

Funder types: Industry

Identifiers

NCT01128530

32729463CSI2001

Details and patient eligibility

About

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).

Enrollment: 161 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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161 participants in 2 patient groups

JNJ-32729463

Experimental group

Description:

JNJ-32729463 250 mg tablet and matching linezolid placebo twice daily

Treatment:

Drug: linezolid placebo

Drug: JNJ-32729463

linezolid

Active Comparator group

Description:

linezolid 600 mg tablet and matching JNJ-32729463 placebo twice daily

Treatment:

Drug: JNJ-32729463 placebo

Drug: linezolid