Efficacy and Safety Study of JNJ-32729463 Compared With Moxifloxacin for the Treatment of Subjects Requiring Hospitalization for Community-Acquired Bacterial Pneumonia

Recruitment & Eligibility

Inclusion Criteria

women of childbearing potential must agree to use an acceptable method of birth control
clinical diagnosis of community acquired bacterial pneumonia (CABP)
PORT score of II or greater
able to generate an adequate sputum specimen
chest x-ray showing presence of new infiltrates in a lobar or multilobar distribution characteristic of bacterial pneumonia

Exclusion Criteria

history of tendon damage/disorders due to quinolone therapy
uncorrected hypokalemia
history of myasthenia gravis
intubated at the time of consent OR subject is a candidate for enrollment into the open-label S. aureus arm and has been intubated greater than 12 hours prior to randomization
mild CABP with a PORT score of less than II
viral, fungal, mycobacterial, or atypical pneumonia as a primary diagnosis
pneumonia suspected to be secondary to aspiration
primary, solitary lung abscess
healthcare-associated pneumonia, hospital-acquired pneumonia, or ventilator-associated pneumonia
known bronchial obstruction or a history of postobstructive pneumonia.
primary lung cancer or another malignancy metastatic to the lungs
cystic fibrosis, known or suspected Pneumocystis jiroveci (carinii) pneumonia, or known or suspected active tuberculosis
infection that necessitates the use of a concomitant antibacterial agent in addition to study medication
systemic antibiotics within the last 96 hours before randomization, with exceptions
hospitalized for greater than 72 hours for any reason 30 days before randomization (excluding the 24 hour period before enrollment).
history of a serious hypersensitivity reaction to any quinolone including moxifloxacin.
female and pregnant, breastfeeding, or may be pregnant.

Other protocol-specific eligibility criteria may apply

Arm && Interventions

Group	Intervention	Description
JNJ-32729463 Open-Label	JNJ-32729463 (Open-Label)	subjects with suspected or confirmed S. aureus CABP may be entered into an open-label JNJ 32729463 treatment group at selected study sites
JNJ-32729463	JNJ-32729463	-
moxifloxacin	moxifloxacin	-

Primary Outcome Measures

Name	Time	Method
Resolution of signs and symptoms of community-acquired bacterial pneumonia	Day 19 (Test of Cure Visit)

Secondary Outcome Measures

Name	Time	Method
Daily signs and symptoms of CABP	Up to Day 19
Microbiological response: per-pathogen and per-subject	Day 19 (Test of Cure Visit)
Percent of subjects with resolution of signs and symptoms of CABP	Day 3 and Day 4
Clinical outcome in subjects with S. pneumoniae	Day 19 (Test of Cure Visit)
Rate of superinfections or new infections	Day 30
Time to oral switch	Day 14
All-cause mortality	Up to Day 30