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

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Community-Acquired Bacterial Pneumonia (CABP)

In brief

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).

Key facts

Study ID

NCT01198626

Run by

Furiex Pharmaceuticals, Inc

People needed

32

Starts

2010-10-01

Expected to finish

2011-10-01

Last updated by the study team

2011-12-08

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Furiex Research Site — Mobile, Alabama, United States
• Furiex Research Site — Sylmar, California, United States
• Furiex Research Site — Orlando, Florida, United States
• Furiex Research Site — Vero Beach, Florida, United States
• Furiex Research Site — Peoria, Illinois, United States
• Furiex Research Site — Hazard, Kentucky, United States
• Furiex Research Site — Anaconda, Montana, United States
• Furiex Research Site — Omaha, Nebraska, United States
• Furiex Research Site — Albueuerque, New Mexico, United States
• Furiex Research Site — Austin, Texas, United States
• Furiex Research Site — Austin, Texas, United States
• Furiex Research Site — Austin, Texas, United States
• Furiex Research Site — Longview, Washington, United States
• Furiex Research Site — Calgary, Alberta, Canada
• Furiex Research Site — Chicoutimi, Quebec, Canada
• Furiex Research Site — Québec, Quebec, Canada
• Furiex Research Site — Bogotá, Colombia
• Furiex Research Site — Cali, Colombia
• Furiex Research Site — Greifswald, Germany
• Furiex Research Site — Hanover, Germany
• Furiex Research Site — Hofheim, Germany
• Furiex Research Site — Homburg/Saar, Germany
• Furiex Research Site — Paderborn, Germany
• Furiex Research Site — Csorna, Hungary
• Furiex Research Site — Debrecen, Hungary

Full record on ClinicalTrials.gov

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