Trial Profile
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
Status:
Completed
Phase of Trial:
Phase III
Latest Information Update: 22 Oct 2020
Price :
$35
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At a glance
- Drugs Delafloxacin (Primary) ; Delafloxacin (Primary) ; Linezolid; Moxifloxacin; Moxifloxacin
- Indications Bacterial infections; Community-acquired pneumonia
- Focus Registrational; Therapeutic Use
- Acronyms DEFINE-CABP
- Sponsors Melinta Therapeutics
- 17 Aug 2020 Data from this study (n=520) used in assessing efficacy of delafloxacin versus moxifloxacin against atypical bacterial respiratory pathogens in adults with community-acquired bacterial pneumonia presented at the ASM Microbe Online 2020
- 16 Dec 2019 Results published in the Antimicrobial Agents and Chemotherapy
- 24 Oct 2019 According to a Melinta Therapeutics media release, the U.S. Food and Drug Administration (FDA) has approved BAXDELA (delafloxacin) for the treatment of adult patients with community-acquired bacterial pneumonia (CABP) caused by designated susceptible bacteria.