Efficacy and Safety Study of JNJ-32729463 Compared With Moxifloxacin for the Treatment of Subjects Requiring Hospitalization for Community-Acquired Bacterial Pneumonia
NCT ID: NCT01198626
Last Updated: 2011-12-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
32 participants
INTERVENTIONAL
2010-10-31
2011-10-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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JNJ-32729463
JNJ-32729463
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
moxifloxacin
moxifloxacin
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.
JNJ-32729463 Open-Label
subjects with suspected or confirmed S. aureus CABP may be entered into an open-label JNJ 32729463 treatment group at selected study sites
JNJ-32729463 (Open-Label)
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.
Interventions
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JNJ-32729463
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
moxifloxacin
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.
JNJ-32729463 (Open-Label)
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
85 Years
ALL
No
Sponsors
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Furiex Pharmaceuticals, Inc
INDUSTRY
Responsible Party
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Locations
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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
Furiex Research Site
Gyöngyös, , Hungary
Furiex Research Site
Miskolc, , Hungary
Furiex Research Site
Tatabánya, , Hungary
Furiex Research Site
Bialystok, , Poland
Furiex Research Site
Bydgoszcz, , Poland
Furiex Research Site
Bystra, , Poland
Furiex Research Site
Lodz, , Poland
Furiex Research Site
Skierniewice, , Poland
Furiex Research Site
Warsaw, , Poland
Countries
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Other Identifiers
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32729463CAP2001
Identifier Type: -
Identifier Source: org_study_id