Clinical trial NCT01128530: Efficacy and Safety Study of JNJ-32729463 for Treating Complicated Skin and Skin Structure Infections Compared to Linezolid (Zyvox)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Complicated Skin and Skin Structure Infections
Keywords: 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
Lead sponsor: Furiex Pharmaceuticals, Inc
Sponsor class: INDUSTRY
First posted: 2010-05-24
Enrollment: 161
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: 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

Primary outcomes:
measure: Cessation of spread or reduction in the size of the primary infection site lesion
timeFrame: 48-72 hours
measure: Defervescence
timeFrame: 48 - 72 hours
Secondary outcomes:
measure: Severity of signs and symptoms of the primary infection site lesion
timeFrame: up to day 84-98 (late follow-up visit)
measure: Clinical response rate - overall and for MRSA
timeFrame: Day 10 (TOC visit), Day 15-21 (SFU/EOT visit)
measure: Microbiological response rate - overall and for MRSA
timeFrame: Day 15-21 (SFU/EOT visit)
measure: Change in susceptibility testing of S. aureus
timeFrame: Day 15-21 (SFU/EOT visit)
measure: Rate of recurrence and new infection in subjects with MRSA
timeFrame: Day 35-49 and Day 84-98
measure: Defervescence
timeFrame: Day 4 (Visit 3)
measure: Cessation of spread or reduction in the size of the primary infection site lesion
timeFrame: Day 4 (Visit 3)
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: Furiex Research Site
state: California
city: Buena Park
country: United States
facility: Furiex Research Site
state: California
city: Chula Vista
country: United States
facility: Furiex Research Site
state: California
city: Fountain Valley
country: United States
facility: Furiex Research Site
state: California
city: La Mesa
country: United States
facility: Furiex Research Site
state: California
city: Long Beach
country: United States
facility: Furiex Research Site
state: California
city: Oceanside
country: United States
facility: Furiex Research Site
state: California
city: Santa Ana
country: United States
facility: Furiex Research Site
state: California
city: Fort Myers
country: United States
facility: Furiex Research Site
state: Florida
city: Kissimmee
country: United States
facility: Furiex Research Site
state: Florida
city: St. Cloud
country: United States
facility: Furiex Research Site
state: Florida
city: Columbus
country: United States
facility: Furiex Research Site
state: Georgia
city: Savannah
country: United States
facility: Furiex Research Site
state: Georgia
city: Idaho Falls
country: United States
facility: Furiex Research Site
state: Idaho
city: Libertyville
country: United States
facility: Furiex Research Site
state: Illinois
city: Baton Rouge
country: United States
facility: Furiex Research Site
state: Louisiana
city: New Orleans
country: United States
facility: Furiex Research Site
state: Louisiana
city: Sulphur
country: United States
facility: Furiex Research Site
state: Louisiana
city: Detroit
country: United States
facility: Furiex Research Site
state: Michigan
city: Keego Harbor
country: United States
facility: Furiex Research Site
state: Michigan
city: Butte
country: United States
facility: Furiex Research Site
state: Montana
city: Toledo
country: United States
facility: Furiex Research Site
state: Ohio
city: Philadelphia
country: United States
facility: Furiex Research Site
state: Pennsylvania
city: Houston
country: United States
facility: Furiex Research Site
state: Texas
city: Houston
country: United States
facility: Furiex Research Site
state: Texas
city: Sugar Land
country: United States
facility: Furiex Research Site
state: Texas
city: Webster
country: United States
facility: Furiex Research Site
state: Texas
Study officials:
References: