Study to Compare Delafloxacin to Moxifloxacin for the Treatment of Adults With Community-acquired Bacterial Pneumonia (DEFINE-CABP)
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|ClinicalTrials.gov Identifier: NCT02679573|
Recruitment Status : Completed
First Posted : February 10, 2016
Results First Posted : February 27, 2020
Last Update Posted : February 27, 2020
|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 of the other symptoms in the ITT population. Symptom severity evaluated by the investigator on a 4-point scale: Absent (0), Mild (1), Moderate (2), Severe (3). Improvement defined as at least a 1-point decrease from baseline.
- 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 in the ITT population. Symptom severity evaluated by the investigator on a 4-point scale: Absent (0), Mild (1), Moderate (2), Severe (3). Improvement defined as at least a 1-point decrease from baseline. Improvement in vital signs defined as a return to normal of any abnormal vital signs at baseline, and no worsening (ie, be abnormal) of any vital sign that was normal at baseline.
- 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 ITT population.
- 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 ITT population.
- Microbiologic Response [ Time Frame: 5 to 10 days after the last dose of study drug ]Microbiological response for subjects in the MITT 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) ]Time to all-cause Mortality was assessed on Day 28.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02679573
|Study Director:||Sue Cammarata, MD||Melinta Therapeutics, Inc.|