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

Furiex Pharmaceuticals

Status and phase: Terminated; Phase 2

Conditions: Community-Acquired Bacterial Pneumonia (CABP)

Treatments: Drug: JNJ-32729463; Drug: moxifloxacin; Drug: JNJ-32729463 (Open-Label)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01198626

32729463CAP2001

Details and patient eligibility

About

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).

Enrollment: 32 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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32 participants in 3 patient groups

JNJ-32729463

Experimental group

Treatment:

Drug: JNJ-32729463

moxifloxacin

Active Comparator group

Treatment:

Drug: moxifloxacin

JNJ-32729463 Open-Label

Experimental group

Description:

subjects with suspected or confirmed S. aureus CABP may be entered into an open-label JNJ 32729463 treatment group at selected study sites

Treatment:

Drug: JNJ-32729463 (Open-Label)