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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
161
250 mg tablet twice daily
600 mg tablet twice daily
1 placebo tablet twice daily
Furiex Research Site
Cessation of spread or reduction in the size of the primary infection site lesion
Time frame: 48-72 hours
Defervescence
Time frame: 48 - 72 hours
Severity of signs and symptoms of the primary infection site lesion
Time frame: up to day 84-98 (late follow-up visit)
Clinical response rate - overall and for MRSA
Time frame: Day 10 (TOC visit), Day 15-21 (SFU/EOT visit)
Microbiological response rate - overall and for MRSA
Time frame: Day 15-21 (SFU/EOT visit)
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
Time frame: Day 15-21 (SFU/EOT visit)
Rate of recurrence and new infection in subjects with MRSA
Time frame: Day 35-49 and Day 84-98
Defervescence
Time frame: Day 4 (Visit 3)
Cessation of spread or reduction in the size of the primary infection site lesion
Time frame: Day 4 (Visit 3)
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1 placebo tablet, twice daily
Anaheim, California, United States
Furiex Research Site
Buena Park, California, United States
Furiex Research Site
Chula Vista, California, United States
Furiex Research Site
Fountain Valley, California, United States
Furiex Research Site
La Mesa, California, United States
Furiex Research Site
Long Beach, California, United States
Furiex Research Site
Oceanside, California, United States
Furiex Research Site
Santa Ana, California, United States
Furiex Research Site
Fort Myers, Florida, United States
Furiex Research Site
Kissimmee, Florida, United States
...and 17 more locations