Clinical Trial: Study to Compare Delafloxacin to Moxifloxacin for the Treatment of Adults With Community-acquired Bacterial Pneumonia

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Phase 3, Multicenter, Randomized, Double-Blind, Comparator-Controlled Study to Evaluate the Safety and Efficacy of Intravenous to Oral Delafloxacin in Adult Subjects With Community-Acquired

Brief Summary: The purpose of this study is to evaluate the safety and efficacy of delafloxacin compared to moxifloxacin in the treatment of adult patients with community-acquired pneumonia.

Detailed Summary: The purpose of this study is to determine if delafloxacin, an investigational drug, is safe and effective in the treatment of community-acquired bacterial pneumonia compared with moxifloxacin, or linezolid in the case of confirmed MRSA.
Sponsor: Melinta Therapeutics, Inc.

Current Primary Outcome: Early Clinical Response [ Time Frame: 96 (+/- 24) hours after the first dose of study drug ]

Early clinical response defined as improvement in at least 2 of the following symptoms (as assessed by the investigator): chest pain, frequency or severity of cough, amount and quality of productive sputum, and difficulty breathing, and no worsening in the other symptoms in the ITT population.


Original Primary Outcome: Investigator Assessment of Early Clinical Response [ Time Frame: 96 hours after the first dose of study drug ]

Investigator assessment of clinical signs and symptoms of pneumonia with early clinical response defined as improvement in at least 2 of the following symptoms: chest pain, cough, productive sputum, and difficulty breathing in the ITT population.


Current Secondary Outcome:

  • Early Clinical Response plus improvement in vital signs and no worsening of the 4 symptoms [ Time Frame: 96 (+/- 24) hours after the first dose of study drug ]
    Early clinical response with the addition of improvement in vital signs and no worsening of the following 4 symptoms: chest pain, cough, productive sputum, and difficulty breathing, required as Response in the ITT population
  • Clinical Outcome at Test of Cure [ Time Frame: 5 to 10 days after the last dose of study drug ]
    Clinical outcome (Success, Failure, or Indeterminate/missing) based on the investigator's assessment of the patient's signs and symptoms of infection in the clinically evaluable and ITT populations.
  • Clinical Outcome at End of Treatment [ Time Frame: Up to 24 (+4) hours after the last dose of study drug ]
    Clinical outcome (Success, Failure, or Indeterminate/missing) based on the investigator's assessment of the patient's signs and symptoms of infection in the clinically evaluable and ITT populations.
  • Microbiologic Response [ Time Frame: 5 to 10 days after the last dose of study drug ]
    Microbiological response for subjects in the MITT and ME set will be based on results of the baseline and follow-up cultures and susceptibility testing or serology.
  • All-cause Mortality [ Time Frame: Day 28 (+/- 2 days) ]
    All-cause Mortality


Original Secondary Outcome:

  • Early Clinical Response with the addition of improvement in vital signs and no worsening of the 4 symptoms [ Time Frame: 96 hours after the first dose of study drug ]
    Investigator assessment of early clinical response with the addition of improvement in vital signs and no worsening of the following 4 symptoms: chest pain, cough, productive sputum, and difficulty breathing, required as Response in the ITT population
  • Clinical Outcome at Test of Cure [ Time Frame: 5 to 10 days after the last dose of study drug ]
    Clinical outcome based on the investigator's assessment of the patient's signs and symptoms of infection in the clinically evaluable and ITT populations.


Information By: Melinta Therapeutics, Inc.

Dates:
Date Received: January 27, 2016
Date Started: December 14, 2016
Date Completion: November 2018
Last Updated: May 11, 2017
Last Verified: May 2017