Complicated Skin and Skin Structure Infections
Conditions
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
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).
Interventions
DRUGJNJ-32729463
250 mg tablet twice daily
DRUGlinezolid
600 mg tablet twice daily
DRUGJNJ-32729463 placebo
1 placebo tablet twice daily
1 placebo tablet, twice daily
Sponsors
Furiex Pharmaceuticals, Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cessation of spread or reduction in the size of the primary infection site lesion | 48-72 hours |
| Defervescence | 48 - 72 hours |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Severity of signs and symptoms of the primary infection site lesion | up to day 84-98 (late follow-up visit) | — |
| Defervescence | Day 4 (Visit 3) | — |
| Cessation of spread or reduction in the size of the primary infection site lesion | Day 4 (Visit 3) | — |
| Rate of recurrence and new infection in subjects with MRSA | Day 35-49 and Day 84-98 | — |
| Clinical response rate - overall and for MRSA | Day 10 (TOC visit), Day 15-21 (SFU/EOT visit) | — |
Countries
United States
Outcome results
None listed