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

Study Overview
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Brief Summary
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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).

Official Title
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A Randomized, Controlled, Double-Blind, Double Dummy, Multicenter Phase 2 Study of the Safety/Tolerability and Efficacy of JNJ-32729463 Compared With Linezolid (Zyvox) for the Treatment of Complicated Skin and Skin Structure Infection

Conditions
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Complicated Skin and Skin Structure Infections

Intervention / Treatment
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* Drug: JNJ-32729463
* Drug: linezolid
* Drug: JNJ-32729463 placebo
* Drug: linezolid placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: JNJ-32729463<br>JNJ-32729463 250 mg tablet and matching linezolid placebo twice daily | Drug: JNJ-32729463<br>* 250 mg tablet twice daily<br>Drug: linezolid placebo<br>* 1 placebo tablet, twice daily<br>|
| Active Comparator: linezolid<br>linezolid 600 mg tablet and matching JNJ-32729463 placebo twice daily | Drug: linezolid<br>* 600 mg tablet twice daily<br>* Other names: Zyvox;Drug: JNJ-32729463 placebo<br>* 1 placebo tablet twice daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cessation of spread or reduction in the size of the primary infection site lesion |  | 48-72 hours | 
| Defervescence |  | 48 - 72 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Severity of signs and symptoms of the primary infection site lesion |  | up to day 84-98 (late follow-up visit) | 
| Clinical response rate - overall and for MRSA |  | Day 10 (TOC visit), Day 15-21 (SFU/EOT visit) | 
| Microbiological response rate - overall and for MRSA |  | Day 15-21 (SFU/EOT visit) | 
| Change in susceptibility testing of S. aureus | Changes in susceptibility testing of S. aureus isolates from the original infection site to linezolid and JNJ-32729463 | Day 15-21 (SFU/EOT visit) | 
| Rate of recurrence and new infection in subjects with MRSA |  | Day 35-49 and Day 84-98 | 
| Defervescence |  | Day 4 (Visit 3) | 
| Cessation of spread or reduction in the size of the primary infection site lesion |  | Day 4 (Visit 3) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cSSSI, complicated skin and skin structure infections, acute bacterial skin and skin structure infections, abscess, cellulitis, bacterial infections, anti-bacterial agents, anti-infective agents, skin diseases, infectious, skin diseases, wound infection