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

Furiex Pharmaceuticals, Inc1 site in 1 country32 target enrollmentOctober 2010

ConditionsCommunity-Acquired Bacterial Pneumonia (CABP)

InterventionsJNJ-32729463 moxifloxacin JNJ-32729463 (Open-Label)

DrugsJNJ-32729463 moxifloxacin JNJ-32729463 (Open-Label)

Overview

Phase: Phase 2
Intervention: JNJ-32729463
Conditions: Community-Acquired Bacterial Pneumonia (CABP)
Sponsor: Furiex Pharmaceuticals, Inc
Enrollment: 32
Locations: 1
Primary Endpoint: Resolution of signs and symptoms of community-acquired bacterial pneumonia
Status: Terminated
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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).

Registry

clinicaltrials.gov

Start Date

October 2010

End Date

October 2011

Last Updated

14 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Furiex Pharmaceuticals, Inc

Responsible Party

Sponsor

Eligibility 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.

Arms & Interventions

JNJ-32729463

Intervention: JNJ-32729463

moxifloxacin

Intervention: moxifloxacin

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: JNJ-32729463 (Open-Label)

Outcomes

Primary Outcomes

Resolution of signs and symptoms of community-acquired bacterial pneumonia

Time Frame: Day 19 (Test of Cure Visit)

Secondary Outcomes

Daily signs and symptoms of CABP(Up to Day 19)
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))
Rate of superinfections or new infections(Day 30)
Time to oral switch(Day 14)
All-cause mortality(Up to Day 30)