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

Information source: Furiex Pharmaceuticals, Inc
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Community-Acquired Bacterial Pneumonia (CABP)

Intervention: JNJ-32729463 (Drug); moxifloxacin (Drug); JNJ-32729463 (Open-Label) (Drug)

Phase: Phase 2

Status: Terminated

Sponsored by: Furiex Pharmaceuticals, Inc

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).

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Resolution of signs and symptoms of community-acquired bacterial pneumonia

Secondary outcome:

Daily signs and symptoms of CABP

Microbiological response: per-pathogen and per-subject

Percent of subjects with resolution of signs and symptoms of CABP

Clinical outcome in subjects with S. pneumoniae

Rate of superinfections or new infections

Time to oral switch

All-cause mortality

Eligibility

Minimum age: 18 Years. Maximum age: 85 Years. Gender(s): Both.

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

Locations and Contacts

Furiex Research Site, Quebec G1V 4G5, Canada

Furiex Research Site, Bogota, Colombia

Furiex Research Site, Cali, Colombia

Furiex Research Site, Greifswald 17475, Germany

Furiex Research Site, Hannover 30625, Germany

Furiex Research Site, Hofheim 65719, Germany

Furiex Research Site, Homburg/Saar 66421, Germany

Furiex Research Site, Paderborn 33098, Germany

Furiex Research Site, Csorna 9300, Hungary

Furiex Research Site, Debrecen 4043, Hungary

Furiex Research Site, Gyongyos 3200, Hungary

Furiex Research Site, Miskolc 3529, Hungary

Furiex Research Site, Tatabanya 2800, Hungary

Furiex Research Site, Bialystok 15-276, Poland

Furiex Research Site, Bydgoszcz 85-681, Poland

Furiex Research Site, Bystra 43-360, Poland

Furiex Research Site, Lodz 90-153, Poland

Furiex Research Site, Skierniewice 96-100, Poland

Furiex Research Site, Warszawa 03-401, Poland

Furiex Research Site, Mobile, Alabama 36608, United States

Furiex Research Site, Calgary, Alberta T2N 4N2, Canada

Furiex Research Site, Sylmar, California 91342, United States

Furiex Research Site, Orlando, Florida 32837, United States

Furiex Research Site, Vero Beach, Florida 32960, United States

Furiex Research Site, Peoria, Illinois 61637, United States

Furiex Research Site, Hazard, Kentucky 41701, United States

Furiex Research Site, Anaconda, Montana 59711, United States

Furiex Research Site, Omaha, Nebraska 68131, United States

Furiex Research Site, Albueuerque, New Mexico 87131, United States

Furiex Research Site, Chicoutimi, Quebec G7H 5H6, Canada

Furiex Research Site, Austin, Texas 78701, United States

Furiex Research Site, Austin, Texas 78705, United States

Furiex Research Site, Austin, Texas 78759, United States

Furiex Research Site, Longview, Washington 98632, United States

Additional Information

Starting date: October 2010
Last updated: December 5, 2011

Page last updated: August 23, 2015

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