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

This study has been terminated.
(Enrollment would not have been met prior to the end of the pneumonia season. Termination is based on slow enrollment and not related to safety or efficacy.)
Sponsor:
Information provided by (Responsible Party):
Furiex Pharmaceuticals, Inc
ClinicalTrials.gov Identifier:
NCT01198626
First received: September 7, 2010
Last updated: December 5, 2011
Last verified: December 2011
  Purpose

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).


Condition Intervention Phase
Community-Acquired Bacterial Pneumonia (CABP)
Drug: JNJ-32729463
Drug: moxifloxacin
Drug: JNJ-32729463 (Open-Label)
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Furiex Pharmaceuticals, Inc:

Primary Outcome Measures:
  • Resolution of signs and symptoms of community-acquired bacterial pneumonia [ Time Frame: Day 19 (Test of Cure Visit) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Daily signs and symptoms of CABP [ Time Frame: Up to Day 19 ] [ Designated as safety issue: No ]
  • Microbiological response: per-pathogen and per-subject [ Time Frame: Day 19 (Test of Cure Visit) ] [ Designated as safety issue: No ]
  • Percent of subjects with resolution of signs and symptoms of CABP [ Time Frame: Day 3 and Day 4 ] [ Designated as safety issue: No ]
  • Clinical outcome in subjects with S. pneumoniae [ Time Frame: Day 19 (Test of Cure Visit) ] [ Designated as safety issue: No ]
  • Rate of superinfections or new infections [ Time Frame: Day 30 ] [ Designated as safety issue: No ]
  • Time to oral switch [ Time Frame: Day 14 ] [ Designated as safety issue: No ]
  • All-cause mortality [ Time Frame: Up to Day 30 ] [ Designated as safety issue: No ]

Enrollment: 32
Study Start Date: October 2010
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01198626

  Show 34 Study Locations
Sponsors and Collaborators
Furiex Pharmaceuticals, Inc
  More Information

No publications provided

Responsible Party: Furiex Pharmaceuticals, Inc
ClinicalTrials.gov Identifier: NCT01198626     History of Changes
Other Study ID Numbers: 32729463CAP2001
Study First Received: September 7, 2010
Last Updated: December 5, 2011
Health Authority: United States: Food and Drug Administration
Hungary: National Institute of Pharmacy
Poland: Ministry of Health
Germany: Federal Institute for Drugs and Medical Devices
Canada: Health Canada

Keywords provided by Furiex Pharmaceuticals, Inc:
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

Additional relevant MeSH terms:
Pneumonia
Pneumonia, Bacterial
Bacterial Infections
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Moxifloxacin
Norgestimate, ethinyl estradiol drug combination
Anti-Bacterial Agents
Anti-Infective Agents
Antineoplastic Agents
Contraceptive Agents
Contraceptive Agents, Female
Contraceptives, Oral
Contraceptives, Oral, Combined
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Therapeutic Uses
Topoisomerase II Inhibitors
Topoisomerase Inhibitors

ClinicalTrials.gov processed this record on October 23, 2014