Clinical Trial: Efficacy and Safety Study of Oral CEM-101 Compared to Oral Levofloxacin in Treatment of Patients With Community-Acquired Bacterial Pneumonia

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Randomized, Double-Blind, Multi-Center Study to Evaluate the Efficacy and Safety of Oral CEM-101 Compared to Oral Levofloxacin in the Treatment of Patients With Community-Acquired

  • Clinical Success in the Intent to Treat (ITT) population at the Treatment of Cure (TOC) visit [ Time Frame: 5 to 10 days after the last dose of study drug ]
    Clinical Success defined as continued improvement or complete resolution of baseline signs and symptoms and if available, an improved/stable chest radiograph after the end of treatment
  • Clinical Success in the Clinically Evaluable (CE) population at the Treatment of Cure (TOC) Visit [ Time Frame: 5 to 10 days after the last dose of study drug ]
    Clinical Success defined as continued improvement or complete resolution of baseline signs and symptoms and if available, an improved/stable chest radiograph after the end of treatment


    • Original Primary Outcome: Clinical Success [ Time Frame: 6 months ]

    Clinical Success, defined as, complete or near complete resolution of disease specific signs and symptoms present at enrollment, no new symptoms or complications attributable to CABP and radiographic resolution, improvement or stability.


    Current Secondary Outcome:

    • By Patient Microbiological Response in the Microbiological Intent to Treat (microlITT) population at the end of treatment (EOT) [ Time Frame: 5 days of study drug treatment ]
      Successful response is eradication, presumed eradication or combined eradication/presumed eradication of baseline pathogen.
    • By Patient Microbiological Response in the Microbiological Intent to Treat (microlITT) population at the Treatment of Cure (TOC) visit [ Time Frame: 5 to 10 days after the last dose of study drug ]
      Successful response is eradication, presumed eradication or combined eradication/presumed eradication of baseline pathogen
    • By-patient Microbiological Response in the Microbiologically Evaluable (ME) populations at the end of treatment (EOT) [ Time Frame: 5 days of study drug treatment ]
      Successful response is eradication, presumed eradication or combined eradication/presumed eradication of baseline pathogen
    • By-patient Microbiological Response in the Microbiologically Evaluable (ME) populations at Treatment of Cure (TOC) visit [ Time Frame: 5 to 10 days after the last dose of study drug ]
      Successful response is eradication, presumed eradication or combined eradication/presumed eradication of baseline pathogen
    • Clinical Response in the Intent to Treat (ITT) population at End of Treatment (EOT) [ Time Frame: 5 days of study drug treatment ]
      Clinical Success is defined as complete or near-complete resolution of the baseline signs and symptoms of community acquired bacterial pneumonia (CABP); no further study drug for treatment of CABP
    • Clinical Response in the microbiological intent to treat (microlITT) population at the end of treatment (EOT) [ Time Frame: 5 days of study drug treatment ]
      Clinical Success is defined as complete or near-complete resolution of the baseline signs and symptoms of community acquired bacterial pneumonia (CABP); no further study drug for treatment of CABP
    • Clinical Response in the clinically evaluable (CE) population at the end of treatment (EOT) [ Time Frame: 5 days of study drug treatment ]
      Clinical Success is defined as complete or near-complete resolution of the baseline signs and symptoms of community acquired bacterial pneumonia (CABP); no further study drug for treatment of CABP
    • Clinical REsponse in the Microbiologically Evaluable (ME) population at the end of treatment (EOT) [ Time Frame: 5 days of study drug treatment ]
      Clinical Success is defined as complete or near-complete resolution of the baseline signs and symptoms of community acquired bacterial pneumonia (CABP); no further study drug for treatment of CABP
    • Early Clinical Response in the intent to treat (ITT) population at Day 3 [ Time Frame: 3 days of study drug treatment ]
      Clinical success is defined as being both clinically stable and showing clinical improvement based on the symptoms of community acquired bacterial pneumonia (CABP)
    • Percentage of patients at each visit who have resolution of all baseline signs and symptoms in the clinically evaluable (CE) population [ Time Frame: Day 3, Day 5 (end of treatment), and 5 to 10 days after the last dose of study drug (test of cure visit) ]
      Resolution of all baseline signs and symptoms in the clinically evaluable (CE) population
    • Percentage of patients at Day 3 who have resolution of cough, dyspnea, chest pain due to pneumonia and sputum production [ Time Frame: 3 days of study drug treatment ]
      Resolution of cough, dyspnea, chest pain due to pneumonia and sputum production
    • Percentage of patients at the end of treatment (EOT) who have resolution of cough, dyspnea, chest pain due to pneumonia and sputum production [ Time Frame: 5 days of study drug treatment ]
      resolution of cough, dyspnea, chest pain due to pneumonia and sputum production
    • Percentage of patients at Day 3 who are clinically stable [ Time Frame: 3 days of study drug treatment ]

      clinical stability defined as:

      • Temperature <=37.8°C
      • Heart rate <=100 beats/min
      • Systolic blood pressure ≥90 mm Hg
      • Ability to maintain oral intake
      • Normal mental status (oriented to person, place or time)
    • Percentage of patients at the end of treatment (EOT) who are clinically stable [ Time Frame: 5 days of study drug treatment ]

      Clinically

      Original Secondary Outcome:

      • Per Patient Per Pathogen Microbiologic Response [ Time Frame: 6 months ]
        Successful response is eradication or presumed eradication of baseline pathogen. Microbiological failure is persistence or recurrence of baseline pathogen.
      • Safety [ Time Frame: 6 months ]
        Summaries of adverse events, routine clinical laboratory evaluations, ECG's, and vital signs will be reviewed for the 2 treatment groups.


      Information By: Cempra Inc

      Dates:
      Date Received: July 22, 2010
      Date Started: August 2010
      Date Completion:
      Last Updated: March 1, 2017
      Last Verified: March 2017