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Trial record 12 of 24 for:    "Bacterial Infectious Disease" | "Polyestradiol phosphate" | ( Map: United States )

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

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ClinicalTrials.gov Identifier: NCT01198626
Recruitment Status : 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.)
First Posted : September 10, 2010
Last Update Posted : December 8, 2011
Sponsor:
Information provided by (Responsible Party):
Furiex Pharmaceuticals, Inc

Tracking Information
First Submitted Date  ICMJE September 7, 2010
First Posted Date  ICMJE September 10, 2010
Last Update Posted Date December 8, 2011
Study Start Date  ICMJE October 2010
Actual Primary Completion Date October 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 9, 2010)
Resolution of signs and symptoms of community-acquired bacterial pneumonia [ Time Frame: Day 19 (Test of Cure Visit) ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01198626 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 13, 2010)
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 9, 2010)
  • Daily signs and symptoms of CABP [ Time Frame: Up to Day 19 ]
  • Microbiological response: per-pathogen and per-subject [ Time Frame: Between Days 7 to 14 (End of Treatment) and 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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety Study of JNJ-32729463 Compared With Moxifloxacin for the Treatment of Subjects Requiring Hospitalization for Community-Acquired Bacterial Pneumonia
Official Title  ICMJE 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
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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Community-Acquired Bacterial Pneumonia (CABP)
Intervention  ICMJE
  • 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.
    Other Name: Avelox
  • 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.
Study Arms  ICMJE
  • Experimental: JNJ-32729463
    Intervention: Drug: JNJ-32729463
  • Active Comparator: moxifloxacin
    Intervention: Drug: 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
    Intervention: Drug: JNJ-32729463 (Open-Label)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: November 8, 2011)
32
Original Estimated Enrollment  ICMJE
 (submitted: September 9, 2010)
120
Actual Study Completion Date  ICMJE October 2011
Actual Primary Completion Date October 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States,   Canada,   Colombia,   Germany,   Hungary,   Poland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01198626
Other Study ID Numbers  ICMJE 32729463CAP2001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Furiex Pharmaceuticals, Inc
Study Sponsor  ICMJE Furiex Pharmaceuticals, Inc
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Furiex Pharmaceuticals, Inc
Verification Date December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP