A Phase 3, Randomized, Double-Blind, Double-Dummy Study to Compare the Efficacy and Safety of Lefamulin (BC 3781) Versus Moxifloxacin (With or Without Adjunctive Linezolid) in Adults With Community-Acquired Bacterial Pneumonia
Phase of Trial: Phase III
Latest Information Update: 24 Oct 2019
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At a glance
- Drugs Lefamulin (Primary) ; Lefamulin (Primary) ; Linezolid; Linezolid; Moxifloxacin; Moxifloxacin
- Indications Community-acquired pneumonia
- Focus Registrational; Therapeutic Use
- Acronyms LEAP; LEAP 1
- Sponsors Nabriva Therapeutics
- 15 Oct 2019 According to a Nabriva Therapeutics media release, pooled results from completed pivotal Lefamulin Evaluation Against Pneumonia (LEAP) 1 and LEAP 2 Phase 3 clinical trials will be featured in three e-poster presentations during a moderated grand-rounds session at the CHEST Annual Meeting 2019 (October 19-23 in New Orleans).
- 19 Aug 2019 Pooled data from LEAP 1 and LEAP 2 published in the Nabriva Therapeutics Media Release.
- 19 Aug 2019 According to an Nabriva Therapeutics media release, the company announced that the U.S. Food and Drug Administration (FDA) has approved new drug applications for the oral and intravenous (IV) formulations of Xenleta™ (lefamulin) for the treatment of community-acquired bacterial pneumonia (CABP) in adults.
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Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History