Community-Acquired Bacterial Pneumonia (CABP)
Conditions
Keywords
community-acquired bacterial pneumonia, CABP, CAP, pneumonia, pneumonia, bacterial, bacterial infections, anti-bacterial agents, anti-infective agents, lung disease, interstitial, respiratory tract diseases, respiratory tract infections, community-acquired infections
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 Bacterial Pneumonia (CABP).
Interventions
DRUGJNJ-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
DRUGmoxifloxacin
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.
DRUGJNJ-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.
Sponsors
Furiex Pharmaceuticals, Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Resolution of signs and symptoms of community-acquired bacterial pneumonia | Day 19 (Test of Cure Visit) |
Secondary
| Measure | Time frame |
|---|---|
| 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) |
| Daily signs and symptoms of CABP | Up to Day 19 |
| Time to oral switch | Day 14 |
| All-cause mortality | Up to Day 30 |
| Rate of superinfections or new infections | Day 30 |
Countries
Canada, Colombia, Germany, Hungary, Poland, United States
Outcome results
None listed