Clinical trial NCT01198626: Efficacy and Safety Study of JNJ-32729463 Compared With Moxifloxacin for the Treatment of Subjects Requiring Hospitalization for Community-Acquired Bacterial Pneumonia
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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Community-Acquired Bacterial Pneumonia (CABP)
Keywords: 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
Lead sponsor: Furiex Pharmaceuticals, Inc
Sponsor class: INDUSTRY
First posted: 2010-09-10
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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.
* 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

Primary outcomes:
measure: Resolution of signs and symptoms of community-acquired bacterial pneumonia
timeFrame: Day 19 (Test of Cure Visit)
Secondary outcomes:
measure: Daily signs and symptoms of CABP
timeFrame: Up to Day 19
measure: Microbiological response: per-pathogen and per-subject
timeFrame: Day 19 (Test of Cure Visit)
measure: Percent of subjects with resolution of signs and symptoms of CABP
timeFrame: Day 3 and Day 4
measure: Clinical outcome in subjects with S. pneumoniae
timeFrame: Day 19 (Test of Cure Visit)
measure: Rate of superinfections or new infections
timeFrame: Day 30
measure: Time to oral switch
timeFrame: Day 14
measure: All-cause mortality
timeFrame: Up to Day 30
Other outcomes:
Locations:
city: Mobile
country: United States
facility: Furiex Research Site
state: Alabama
city: Sylmar
country: United States
facility: Furiex Research Site
state: California
city: Orlando
country: United States
facility: Furiex Research Site
state: Florida
city: Vero Beach
country: United States
facility: Furiex Research Site
state: Florida
city: Peoria
country: United States
facility: Furiex Research Site
state: Illinois
city: Hazard
country: United States
facility: Furiex Research Site
state: Kentucky
city: Anaconda
country: United States
facility: Furiex Research Site
state: Montana
city: Omaha
country: United States
facility: Furiex Research Site
state: Nebraska
city: Albueuerque
country: United States
facility: Furiex Research Site
state: New Mexico
city: Austin
country: United States
facility: Furiex Research Site
state: Texas
city: Austin
country: United States
facility: Furiex Research Site
state: Texas
city: Austin
country: United States
facility: Furiex Research Site
state: Texas
city: Longview
country: United States
facility: Furiex Research Site
state: Washington
city: Calgary
country: Canada
facility: Furiex Research Site
state: Alberta
city: Chicoutimi
country: Canada
facility: Furiex Research Site
state: Quebec
city: Quebec
country: Canada
facility: Furiex Research Site
city: Bogota
country: Colombia
facility: Furiex Research Site
city: Cali
country: Colombia
facility: Furiex Research Site
city: Greifswald
country: Germany
facility: Furiex Research Site
city: Hannover
country: Germany
facility: Furiex Research Site
city: Hofheim
country: Germany
facility: Furiex Research Site
city: Homburg/Saar
country: Germany
facility: Furiex Research Site
city: Paderborn
country: Germany
facility: Furiex Research Site
city: Csorna
country: Hungary
facility: Furiex Research Site
city: Debrecen
country: Hungary
facility: Furiex Research Site
city: Gyongyos
country: Hungary
facility: Furiex Research Site
city: Miskolc
country: Hungary
facility: Furiex Research Site
city: Tatabanya
country: Hungary
facility: Furiex Research Site
city: Bialystok
country: Poland
facility: Furiex Research Site
city: Bydgoszcz
country: Poland
facility: Furiex Research Site
city: Bystra
country: Poland
facility: Furiex Research Site
city: Lodz
country: Poland
facility: Furiex Research Site
city: Skierniewice
country: Poland
facility: Furiex Research Site
city: Warszawa
country: Poland
facility: Furiex Research Site
Study officials:
References: