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

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).

Study Overview

• Status: Terminated
• Conditions: Community-Acquired Bacterial Pneumonia (CABP)
• Intervention / Treatment: Drug: JNJ-32729463; Drug: moxifloxacin; Drug: JNJ-32729463 (Open-Label)

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • Quebec, Canada, G1V 4G5
    • Furiex research site
  • Alberta
    • Calgary, Alberta, Canada, T2N 4N2
      • Furiex research site
  • Quebec
    • Chicoutimi, Quebec, Canada, G7H 5H6
      • Furiex research site
• Colombia
  • Bogota, Colombia
    • Furiex research site
  • Cali, Colombia
    • Furiex research site
• Germany
  • Greifswald, Germany, 17475
    • Furiex research site
  • Hannover, Germany, 30625
    • Furiex research site
  • Hofheim, Germany, 65719
    • Furiex research site
  • Homburg/Saar, Germany, 66421
    • Furiex research site
  • Paderborn, Germany, 33098
    • Furiex research site
• Hungary
  • Csorna, Hungary, 9300
    • Furiex research site
  • Debrecen, Hungary, 4043
    • Furiex research site
  • Gyongyos, Hungary, 3200
    • Furiex research site
  • Miskolc, Hungary, 3529
    • Furiex research site
  • Tatabanya, Hungary, 2800
    • Furiex research site
• Poland
  • Bialystok, Poland, 15-276
    • Furiex research site
  • Bydgoszcz, Poland, 85-681
    • Furiex research site
  • Bystra, Poland, 43-360
    • Furiex research site
  • Lodz, Poland, 90-153
    • Furiex research site
  • Skierniewice, Poland, 96-100
    • Furiex research site
  • Warszawa, Poland, 03-401
    • Furiex research site
• United States
  • Alabama
    • Mobile, Alabama, United States, 36608
      • Furiex research site
  • California
    • Sylmar, California, United States, 91342
      • Furiex research site
  • Florida
    • Orlando, Florida, United States, 32837
      • Furiex research site
    • Vero Beach, Florida, United States, 32960
      • Furiex research site
  • Illinois
    • Peoria, Illinois, United States, 61637
      • Furiex research site
  • Kentucky
    • Hazard, Kentucky, United States, 41701
      • Furiex research site
  • Montana
    • Anaconda, Montana, United States, 59711
      • Furiex research site
  • Nebraska
    • Omaha, Nebraska, United States, 68131
      • Furiex research site
  • New Mexico
    • Albueuerque, New Mexico, United States, 87131
      • Furiex research site
  • Texas
    • Austin, Texas, United States, 78701
      • Furiex research site
    • Austin, Texas, United States, 78705
      • Furiex research site
    • Austin, Texas, United States, 78759
      • Furiex research site
  • Washington
    • Longview, Washington, United States, 98632
      • Furiex research site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: JNJ-32729463	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
Active Comparator: moxifloxacin	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 Names: Avelox
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	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Resolution of signs and symptoms of community-acquired bacterial pneumonia	Day 19 (Test of Cure Visit)

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Furiex Pharmaceuticals, Inc

Study record dates

Study Major Dates

• Study Start: October 1, 2010
• Primary Completion (Actual): October 1, 2011
• Study Completion (Actual): October 1, 2011

Study Registration Dates

• First Submitted: September 7, 2010
• First Submitted That Met QC Criteria: September 9, 2010
• First Posted (Estimate): September 10, 2010

Study Record Updates

• Last Update Posted (Estimate): December 8, 2011
• Last Update Submitted That Met QC Criteria: December 5, 2011
• Last Verified: December 1, 2011

More Information

Terms related to this study

• Keywords: pneumonia; CAP; respiratory tract diseases; bacterial infections; CABP; respiratory tract infections; community-acquired bacterial pneumonia; pneumonia, bacterial; anti-bacterial agents; anti-infective agents; lung disease, interstitial; community-acquired infections
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Pneumonia; Pneumonia, Bacterial; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antineoplastic Agents; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Anti-Bacterial Agents; Moxifloxacin
• Other Study ID Numbers: 32729463CAP2001