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

A Randomized, Controlled, Double Blind, Multicenter, Phase 2 Study of the Safety/Tolerability and Efficacy of JNJ-32729463 Compared With Moxifloxacin for the Treatment of Subjects Requiring Hospitalization for Community-Acquired Bacterial Pneumonia (CABP) With a PORT Score of II or Greater

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