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

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

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 Hospitaliz

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 Summary:
Sponsor: Furiex Pharmaceuticals, Inc

Current Primary Outcome: Resolution of signs and symptoms of community-acquired bacterial pneumonia [ Time Frame: Day 19 (Test of Cure Visit) ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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:

  • 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 ]


Information By: Furiex Pharmaceuticals, Inc

Dates:
Date Received: September 7, 2010
Date Started: October 2010
Date Completion:
Last Updated: December 5, 2011
Last Verified: December 2011