Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

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.)
Information provided by (Responsible Party):
Furiex Pharmaceuticals, Inc Identifier:
First received: September 7, 2010
Last updated: December 5, 2011
Last verified: December 2011
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
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, 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) ]

Secondary Outcome 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 ]

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.


Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 identifier: NCT01198626

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

Responsible Party: Furiex Pharmaceuticals, Inc Identifier: NCT01198626     History of Changes
Other Study ID Numbers: 32729463CAP2001
Study First Received: September 7, 2010
Last Updated: December 5, 2011

Keywords provided by Furiex Pharmaceuticals, Inc:
community-acquired bacterial 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, Bacterial
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Bacterial Infections
Norgestimate, ethinyl estradiol drug combination
Anti-Bacterial Agents
Anti-Infective Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Contraceptives, Oral, Combined
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Nucleic Acid Synthesis Inhibitors processed this record on May 25, 2017