Status:
TERMINATED
Efficacy and Safety Study of JNJ-32729463 Compared With Moxifloxacin for the Treatment of Subjects Requiring Hospitalization for Community-Acquired Bacterial Pneumonia
Lead Sponsor:
Furiex Pharmaceuticals, Inc
Conditions:
Community-Acquired Bacterial Pneumonia (CABP)
Eligibility:
All Genders
18-85 years
Phase:
PHASE2
Brief 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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2011
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT01198626
Start Date
October 1 2010
End Date
October 1 2011
Last Update
December 8 2011
Active Locations (34)
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1
Furiex Research Site
Mobile, Alabama, United States, 36608
2
Furiex Research Site
Sylmar, California, United States, 91342
3
Furiex Research Site
Orlando, Florida, United States, 32837
4
Furiex Research Site
Vero Beach, Florida, United States, 32960