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