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
Status:
Completed
Phase of Trial:
Phase III
Latest Information Update: 22 Jul 2022
Price :
$35
*
At a glance
- Drugs Lefamulin (Primary) ; Lefamulin (Primary) ; Linezolid; Linezolid; Moxifloxacin; Moxifloxacin
- Indications Bacterial infections; Community-acquired pneumonia
- Focus Registrational; Therapeutic Use
- Acronyms LEAP; LEAP 1
- Sponsors Nabriva Therapeutics
- 15 Oct 2021 According to an Nabriva Therapeutics media release, Pooled Analysis from LEAP 1 and LEAP 2 Trials will be presented at CHEST 2021, the annual meeting of the American College of CHEST Physicians.
- 21 Oct 2020 Results (n=1289) of pooled analysis of the Lefamulin evaluation against pneumonia (Leap) 1 and Leap 2 trials assessing efficacy/safety outcomes by age group (18-64, 65-74, 75-84, and less than or equal to 85years), presented at the CHEST Annual Meeting 2020 by Annual Meeting of the American College of Chest Physicians.
- 28 Jul 2020 According to a Nabriva Therapeutics media release, the European Commission (EC) has issued a legally binding decision for approval of the marketing authorization application for XENLETA™ (lefamulin) for the treatment of community-acquired pneumonia (CAP) in adults following a review by the European Medicines Agency (EMA). he EMA approval is based on efficacy data from the Lefamulin Evaluation Against Pneumonia (LEAP) 1 and LEAP 2 studies and a safety database of 1,242 study participants.