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

Study Overview
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Brief Summary
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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).

Official Title
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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

Conditions
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Community-Acquired Bacterial Pneumonia (CABP)

Intervention / Treatment
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* Drug: JNJ-32729463
* Drug: moxifloxacin
* Drug: JNJ-32729463 (Open-Label)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: JNJ-32729463<br> | Drug: JNJ-32729463<br>* 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<br>|
| Active Comparator: moxifloxacin<br> | Drug: moxifloxacin<br>* 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.<br>* Other names: Avelox;|
| Experimental: JNJ-32729463 Open-Label<br>subjects with suspected or confirmed S. aureus CABP may be entered into an open-label JNJ 32729463 treatment group at selected study sites | Drug: JNJ-32729463 (Open-Label)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Resolution of signs and symptoms of community-acquired bacterial pneumonia |  | Day 19 (Test of Cure Visit) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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anti-bacterial agents, community-acquired bacterial pneumonia, CABP, CAP, pneumonia, pneumonia, bacterial, bacterial infections, anti-infective agents, lung disease, interstitial, respiratory tract diseases, respiratory tract infections, community-acquired infections