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

Overview

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).

Full Title of Study: “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

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: October 2011

Interventions

  • 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
  • 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.
  • 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.

Arms, Groups and Cohorts

  • Experimental: JNJ-32729463
  • Active Comparator: moxifloxacin
  • 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

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

  • Daily signs and symptoms of CABP
    • Time Frame: Up to Day 19
  • Microbiological response: per-pathogen and per-subject
    • Time Frame: Day 19 (Test of Cure Visit)
  • Percent of subjects with resolution of signs and symptoms of CABP
    • Time Frame: Day 3 and Day 4
  • Clinical outcome in subjects with S. pneumoniae
    • Time Frame: Day 19 (Test of Cure Visit)
  • Rate of superinfections or new infections
    • Time Frame: Day 30
  • Time to oral switch
    • Time Frame: Day 14
  • All-cause mortality
    • Time Frame: Up to Day 30

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 85 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Furiex Pharmaceuticals, Inc
  • Provider of Information About this Clinical Study
    • Sponsor

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