The purpose of this study is to determine the efficacy, safety and tolerability of JNJ-32729463 compared to moxifloxacin for the treatment of subjects requiring hospitalization for Community-Acquired Bacterial Pneumonia (CABP).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
32
150 mg intravenous formulation administered twice daily for at least 72 hours, followed by 250 mg oral formulation administered twice daily for a total treatment time of 7 to 14 days
400 mg intravenous formulation administered once daily for at least 72 hours, followed by 400 mg oral formulation administered once daily for a total treatment time of 7 to 14 days. To maintain the blind, subjects will receive one dose of moxifloxacin and one dose of placebo daily.
Subjects may receive JNJ-32729463 intravenous formulation up to 150 mg either BID or TID followed by 250 mg oral formulation BID for a total treatment time of 7 to 14 days.
Resolution of signs and symptoms of community-acquired bacterial pneumonia
Time frame: Day 19 (Test of Cure Visit)
Daily signs and symptoms of CABP
Time frame: Up to Day 19
Microbiological response: per-pathogen and per-subject
Time frame: Day 19 (Test of Cure Visit)
Percent of subjects with resolution of signs and symptoms of CABP
Time frame: Day 3 and Day 4
Clinical outcome in subjects with S. pneumoniae
Time frame: Day 19 (Test of Cure Visit)
Rate of superinfections or new infections
Time frame: Day 30
Time to oral switch
Time frame: Day 14
All-cause mortality
Time frame: Up to Day 30
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