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:

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

History of Changes

Tracking Information
First Received Date ^ICMJE	September 7, 2010
Last Updated Date	December 5, 2011
Start Date ^ICMJE	October 2010
Primary Completion Date	October 2011 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: September 9, 2010)	Resolution of signs and symptoms of community-acquired bacterial pneumonia [ Time Frame: Day 19 (Test of Cure Visit) ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01198626 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: October 13, 2010)	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 ]
Original Secondary Outcome Measures ^ICMJE (submitted: September 9, 2010)	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: Between Days 7 to 14 (End of Treatment) and 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 ]
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Efficacy and Safety Study of JNJ-32729463 Compared With Moxifloxacin for the Treatment of Subjects Requiring Hospitalization for Community-Acquired Bacterial Pneumonia
Official Title ^ICMJE	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
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).
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 2
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Condition ^ICMJE	Community-Acquired Bacterial Pneumonia (CABP)
Intervention ^ICMJE	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 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 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.
Study Arm (s)	Experimental: JNJ-32729463 Intervention: Drug: JNJ-32729463 Active Comparator: moxifloxacin Intervention: Drug: moxifloxacin 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 Intervention: Drug: JNJ-32729463 (Open-Label)
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Terminated
Enrollment ^ICMJE	32
Completion Date	October 2011
Primary Completion Date	October 2011 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years to 85 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States, Canada, Colombia, Germany, Hungary, Poland

Administrative Information
NCT Number ^ICMJE	NCT01198626
Other Study ID Numbers ^ICMJE	32729463CAP2001
Has Data Monitoring Committee	No
Responsible Party	Furiex Pharmaceuticals, Inc
Study Sponsor ^ICMJE	Furiex Pharmaceuticals, Inc
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Furiex Pharmaceuticals, Inc
Verification Date	December 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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