Efficacy and Safety Study of JNJ-32729463 for Treating Complicated Skin and Skin Structure Infections Compared to Linezolid (Zyvox)
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
1 other identifier
interventional
161
1 country
27
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jun 2010
Shorter than P25 for phase_2
27 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 20, 2010
CompletedFirst Posted
Study publicly available on registry
May 24, 2010
CompletedStudy Start
First participant enrolled
June 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2011
CompletedDecember 16, 2011
December 1, 2011
6 months
May 20, 2010
December 9, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Cessation of spread or reduction in the size of the primary infection site lesion
48-72 hours
Defervescence
48 - 72 hours
Secondary Outcomes (7)
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)
Rate of recurrence and new infection in subjects with MRSA
Day 35-49 and Day 84-98
- +2 more secondary outcomes
Study Arms (2)
JNJ-32729463
EXPERIMENTALJNJ-32729463 250 mg tablet and matching linezolid placebo twice daily
linezolid
ACTIVE COMPARATORlinezolid 600 mg tablet and matching JNJ-32729463 placebo twice daily
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (27)
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
Furiex Research Site
Long Beach, California, 90813, United States
Furiex Research Site
Oceanside, California, 92056, United States
Furiex Research Site
Santa Ana, California, 92701, United States
Furiex Research Site
Fort Myers, Florida, 33912, United States
Furiex Research Site
Kissimmee, Florida, 34741, United States
Furiex Research Site
Saint Cloud, Florida, 34769, United States
Furiex Research Site
Columbus, Georgia, 31904, United States
Furiex Research Site
Savannah, Georgia, 31406, United States
Furiex Research Site
Idaho Falls, Idaho, 83404, United States
Furiex Research Site
Libertyville, Illinois, 60048, United States
Furiex Research Site
Baton Rouge, Louisiana, 70809, United States
Furiex Research Site
New Orleans, Louisiana, 70112, United States
Furiex Research Site
Sulphur, Louisiana, 70663, United States
Furiex Research Site
Detroit, Michigan, 48202, United States
Furiex Research Site
Keego Harbor, Michigan, 48320, United States
Furiex Research Site
Butte, Montana, 59701, United States
Furiex Research Site
Toledo, Ohio, 43608, United States
Furiex Research Site
Philadelphia, Pennsylvania, 19107, United States
Furiex Research Site
Houston, Texas, 77002, United States
Furiex Research Site
Houston, Texas, 77005, United States
Furiex Research Site
Sugar Land, Texas, 77498, United States
Furiex Research Site
Webster, Texas, 77598, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
May 20, 2010
First Posted
May 24, 2010
Study Start
June 1, 2010
Primary Completion
December 1, 2010
Study Completion
January 1, 2011
Last Updated
December 16, 2011
Record last verified: 2011-12