A Phase 3, Randomized, Double-Blind, Double-Dummy Study to Compare the Efficacy and Safety of Oral Lefamulin (BC 3781) Versus Oral Moxifloxacin 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 Oral Lefamulin (BC 3781) Versus Oral Moxifloxacin in Adults With Community-Acquired Bacterial Pneumonia

Completed
Phase of Trial: Phase III

Latest Information Update: 28 Mar 2018

At a glance

  • Drugs Lefamulin (Primary) ; Moxifloxacin
  • Indications Community-acquired pneumonia
  • Focus Registrational; Therapeutic Use
  • Acronyms LEAP 2
  • Sponsors Nabriva Therapeutics
  • Most Recent Events

    • 16 Mar 2018 According to a Nabriva Therapeutics media release, based on the data from this trial company plans to file a New Drug Application for lefamulin with the U.S. Food and Drug Administration in the second half of this year.
    • 16 Mar 2018 According to a Nabriva Therapeutics media release, data read-out is expected in the spring of 2018
    • 17 Jan 2018 Status changed from active, no longer recruiting to completed.
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