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

Complicated Skin and Skin Structure Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01128530
• Other study ID #: 32729463CSI2001
• Status: Completed
• Phase: Phase 2
• First received: May 20, 2010
• Last updated: December 9, 2011
• Start date: June 2010
• Est. completion date: January 2011

Study information

• Verified date: December 2011
• Source: Furiex Pharmaceuticals, Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 161
• Est. completion date: January 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Communicable Diseases
• Complicated Skin and Skin Structure Infections
• Infection

Intervention

Drug:
• JNJ-32729463
250 mg tablet twice daily
• linezolid
600 mg tablet twice daily
• JNJ-32729463 placebo
1 placebo tablet twice daily
• linezolid placebo
1 placebo tablet, twice daily

Locations

Country	Name	City	State
United States	Furiex Research Site	Anaheim	California
United States	Furiex Research Site	Baton Rouge	Louisiana
United States	Furiex Research Site	Buena Park	California
United States	Furiex Research Site	Butte	Montana
United States	Furiex Research Site	Chula Vista	California
United States	Furiex Research Site	Columbus	Georgia
United States	Furiex Research Site	Detroit	Michigan
United States	Furiex Research Site	Fort Myers	Florida
United States	Furiex Research Site	Fountain Valley	California
United States	Furiex Research Site	Houston	Texas
United States	Furiex Research Site	Houston	Texas
United States	Furiex Research Site	Idaho Falls	Idaho
United States	Furiex Research Site	Keego Harbor	Michigan
United States	Furiex Research Site	Kissimmee	Florida
United States	Furiex Research Site	La Mesa	California
United States	Furiex Research Site	Libertyville	Illinois
United States	Furiex Research Site	Long Beach	California
United States	Furiex Research Site	New Orleans	Louisiana
United States	Furiex Research Site	Oceanside	California
United States	Furiex Research Site	Philadelphia	Pennsylvania
United States	Furiex Research Site	Santa Ana	California
United States	Furiex Research Site	Savannah	Georgia
United States	Furiex Research Site	St. Cloud	Florida
United States	Furiex Research Site	Sugar Land	Texas
United States	Furiex Research Site	Sulphur	Louisiana
United States	Furiex Research Site	Toledo	Ohio
United States	Furiex Research Site	Webster	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Furiex Pharmaceuticals, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cessation of spread or reduction in the size of the primary infection site lesion		48-72 hours	No
Primary	Defervescence		48 - 72 hours	No
Secondary	Severity of signs and symptoms of the primary infection site lesion		up to day 84-98 (late follow-up visit)	No
Secondary	Clinical response rate - overall and for MRSA		Day 10 (TOC visit), Day 15-21 (SFU/EOT visit)	No
Secondary	Microbiological response rate - overall and for MRSA		Day 15-21 (SFU/EOT visit)	No
Secondary	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)	No
Secondary	Rate of recurrence and new infection in subjects with MRSA		Day 35-49 and Day 84-98	No
Secondary	Defervescence		Day 4 (Visit 3)	No
Secondary	Cessation of spread or reduction in the size of the primary infection site lesion		Day 4 (Visit 3)	No

External Links

•   Journal article reporting results of the Phase 2 study