Efficacy and Safety Study of JNJ-32729463 Compared With Moxifloxacin for the Treatment of Subjects Requiring Hospitalization for Community-Acquired Bacterial Pneumonia
This study has been terminated.
(Enrollment would not have been met prior to the end of the pneumonia season. Termination is based on slow enrollment and not related to safety or efficacy.)
Sponsor:
Furiex Pharmaceuticals, Inc
Information provided by (Responsible Party):
Furiex Pharmaceuticals, Inc
ClinicalTrials.gov Identifier:
NCT01198626
First received: September 7, 2010
Last updated: December 5, 2011
Last verified: December 2011
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Purpose
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).
| Condition | Intervention | Phase |
|---|---|---|
|
Community-Acquired Bacterial Pneumonia (CABP) |
Drug: JNJ-32729463 Drug: moxifloxacin Drug: JNJ-32729463 (Open-Label) |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Randomized, Controlled, Double Blind, Multicenter, Phase 2 Study of the Safety/Tolerability and Efficacy of JNJ-32729463 Compared With Moxifloxacin for the Treatment of Subjects Requiring Hospitalization for Community-Acquired Bacterial Pneumonia (CABP) With a PORT Score of II or Greater |
Resource links provided by NLM:
Further study details as provided by Furiex Pharmaceuticals, Inc:
Primary Outcome Measures:
- Resolution of signs and symptoms of community-acquired bacterial pneumonia [ Time Frame: Day 19 (Test of Cure Visit) ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Daily signs and symptoms of CABP [ Time Frame: Up to Day 19 ] [ Designated as safety issue: No ]
- Microbiological response: per-pathogen and per-subject [ Time Frame: Day 19 (Test of Cure Visit) ] [ Designated as safety issue: No ]
- Percent of subjects with resolution of signs and symptoms of CABP [ Time Frame: Day 3 and Day 4 ] [ Designated as safety issue: No ]
- Clinical outcome in subjects with S. pneumoniae [ Time Frame: Day 19 (Test of Cure Visit) ] [ Designated as safety issue: No ]
- Rate of superinfections or new infections [ Time Frame: Day 30 ] [ Designated as safety issue: No ]
- Time to oral switch [ Time Frame: Day 14 ] [ Designated as safety issue: No ]
- All-cause mortality [ Time Frame: Up to Day 30 ] [ Designated as safety issue: No ]
| Enrollment: | 32 |
| Study Start Date: | October 2010 |
| Study Completion Date: | October 2011 |
| Primary Completion Date: | October 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: JNJ-32729463 |
Drug: 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
|
| Active Comparator: moxifloxacin |
Drug: 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.
Other Name: Avelox
|
|
Experimental: 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
|
Drug: 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.
|
Eligibility| Ages Eligible for Study: | 18 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01198626
Show 34 Study Locations
Show 34 Study LocationsSponsors and Collaborators
Furiex Pharmaceuticals, Inc
More Information
No publications provided
| Responsible Party: | Furiex Pharmaceuticals, Inc |
| ClinicalTrials.gov Identifier: | NCT01198626 History of Changes |
| Other Study ID Numbers: | 32729463CAP2001 |
| Study First Received: | September 7, 2010 |
| Last Updated: | December 5, 2011 |
| Health Authority: | United States: Food and Drug Administration Hungary: National Institute of Pharmacy Poland: Ministry of Health Germany: Federal Institute for Drugs and Medical Devices Canada: Health Canada |
Keywords provided by Furiex Pharmaceuticals, Inc:
|
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 |
Additional relevant MeSH terms:
|
Pneumonia, Bacterial Pneumonia Bacterial Infections Lung Diseases Respiratory Tract Diseases Respiratory Tract Infections Moxifloxacin Anti-Infective Agents Norgestimate, ethinyl estradiol drug combination |
Therapeutic Uses Pharmacologic Actions Contraceptives, Oral, Combined Contraceptives, Oral Contraceptive Agents, Female Contraceptive Agents Reproductive Control Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 16, 2013