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

Trial Profile

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

Completed
Phase of Trial: Phase III

Latest Information Update: 20 Sep 2017

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
  • Most Recent Events

    • 20 Sep 2017 According to a Nabriva Therapeutics media release, the company will provide topline results at the Cantor Fitzgerald Global Healthcare Conference 2017.
    • 18 Sep 2017 According to a Nabriva Therapeutics media release, primary endpoint has been met. (The primary efficacy endpoint for the EMA is the clinical success rate at the Test of Cure (i.e., 510 days after the last dose of study drug) visit for lefamulin in both the Clinically Evaluable and modified ITT populations compared to moxifloxacin.)
    • 18 Sep 2017 Topline data presented in a Nabriva Therapeutics Media Release.
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