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

Phase 2

Completed

• Conditions: Complicated Skin and Skin Structure Infections
• Interventions: Drug: JNJ-32729463; Drug: linezolid; Drug: JNJ-32729463 placebo; Drug: linezolid placebo

• Registration Number: NCT01128530
• Lead Sponsor: Furiex Pharmaceuticals, Inc

Brief 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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-05-20
• Study First Submitted QC: 2010-05-20
• Study First Posted: 2010-05-24
• Study Start: 2010-06
• Primary Completion: 2010-12
• Study Completion: 2011-01
• Disposition First Submitted: 2011-01-25
• Disposition First Submitted QC: 2011-01-25
• Disposition First Posted: 2011-02-01
• Status Verified: 2011-12
• Last Update Submitted: 2011-12-09
• Last Update Posted: 2011-12-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 161

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
JNJ-32729463	JNJ-32729463	JNJ-32729463 250 mg tablet and matching linezolid placebo twice daily
linezolid	linezolid	linezolid 600 mg tablet and matching JNJ-32729463 placebo twice daily
linezolid	JNJ-32729463 placebo	linezolid 600 mg tablet and matching JNJ-32729463 placebo twice daily
JNJ-32729463	linezolid placebo	JNJ-32729463 250 mg tablet and matching linezolid placebo twice daily

Primary Outcome Measures

Name	Time	Method
Cessation of spread or reduction in the size of the primary infection site lesion	48-72 hours
Defervescence	48 - 72 hours

Secondary Outcome Measures

Name	Time	Method
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	Day 15-21 (SFU/EOT visit)	Changes in susceptibility testing of S. aureus isolates from the original infection site to linezolid and JNJ-32729463
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)

Trial Locations

Locations (1)

Furiex Research Site; 🇺🇸 Webster, Texas, United States