Study to Compare Delafloxacin to Moxifloxacin for the Treatment of Adults With Community-acquired Bacterial Pneumonia (DEFINE-CABP)
|ClinicalTrials.gov Identifier: NCT02679573|
Recruitment Status : Completed
First Posted : February 10, 2016
Last Update Posted : July 29, 2019
|Condition or disease||Intervention/treatment||Phase|
|Community Acquired Bacterial Pneumonia||Drug: Delafloxacin Drug: Moxifloxacin Drug: Linezolid||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||860 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|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 Bacterial Pneumonia|
|Actual Study Start Date :||December 14, 2016|
|Actual Primary Completion Date :||July 31, 2018|
|Actual Study Completion Date :||August 7, 2018|
IV delafloxacin with potential to switch to oral delafloxacin
Antibacterial agent, 300 mg IV, Q12H for at least 6 doses with potential to switch to 450 mg oral tablet, Q12H for up to 20 doses total
Other Name: RX-3341
Active Comparator: Moxifloxacin/Linezolid
IV moxifloxacin with potential to switch to oral moxifloxacin, and potential to switch moxifloxacin to IV linezolid for confirmed MRSA
Antibacterial Agent, 400 mg IV, Q24H for at least 3 doses with potential to switch to 400 mg oral over-encapsulated tablet, Q24H for up to 10 doses total
Other Name: Avelox
Antibacterial Agent, at local investigator discretion, subjects in the moxifloxacin arm with confirmed MRSA can switch to linezolid 600 mg IV Q12H for all remaining doses
Other Name: Zyvox
- 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.
- 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02679573
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|Study Director:||Sue Cammarata, MD||Melinta Therapeutics, Inc.|