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