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TERMINATEDPHASE2

Efficacy and Safety Study of JNJ-32729463 Compared With Moxifloxacin for the Treatment of Subjects Requiring Hospitalization for Community-Acquired Bacterial Pneumonia

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

NCT01198626•Furiex Pharmaceuticals, Inc

View on ClinicalTrials.gov

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).

Eligibility

Age

18 - 85 years

Sex

ALL

Healthy Volunteers

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.
+8 more criteria

Locations (34)

Furiex Research Site

Mobile, Alabama, United States

Furiex Research Site

Sylmar, California, United States

Furiex Research Site

Orlando, Florida, United States

Furiex Research Site

Vero Beach, Florida, United States

Furiex Research Site

Peoria, Illinois, United States

Furiex Research Site

Hazard, Kentucky, United States

Furiex Research Site

Anaconda, Montana, United States

Furiex Research Site

Omaha, Nebraska, United States

Furiex Research Site

Albueuerque, New Mexico, United States

Furiex Research Site

Austin, Texas, United States

Key Dates

Start Date

October 1, 2010

Primary Completion Date

October 1, 2011

Completion Date

October 1, 2011

Last Updated

December 8, 2011

Enrollment

ACTUAL participants

Conditions

Community-Acquired Bacterial Pneumonia (CABP)

Interventions

JNJ-32729463

DRUG

moxifloxacin

DRUG

JNJ-32729463 (Open-Label)

DRUG

Safety and Efficacy Study of Ceftaroline in Elderly Subjects With Community-Acquired Bacterial Pneumonia

NCT01666743

Community-Acquired Bacterial Pneumonia (CABP)

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 8, 2011Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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