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

• Status: Terminated
• Trial end date: 2011-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Furiex Pharmaceuticals, Inc
• Treatments: Fluoroquinolones; Moxifloxacin; Norgestimate, ethinyl estradiol drug combination

Criteria

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