At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 551 enrolled
Drug / intervention
lefamulin +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating lefamulin, Moxifloxacin, and 1 other intervention for Community Acquired Pneumonia. Completed, enrolled 551 participants across 99 sites in 18 countries.
Detailed Summary
This study evaluates the safety and efficacy of lefamulin, a pleuromutilin, for the treatment of adults with moderate to severe community-acquired bacterial pneumonia.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCommunity Acquired Pneumonia
CountriesArgentina, Bosnia and Herzegovina, Brazil, Bulgaria, Georgia, Hungary, Latvia, Netherlands, Peru, Philippines, Poland, Romania, Russia, Serbia, South Africa, Thailand, Ukraine, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20162017201820192020202120222023202420252026
Enrollment StartSep 2015
First PostedSep 2015
Primary CompletionApr 2017
Study CompletionMay 2017
TodayJul 2026
First PostedSep 24, 2015
Enrollment StartSep 1, 2015
Primary CompletionApr 1, 2017
Study CompletionMay 1, 2017
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 10.8 years ago
Interventions
lefamulindrug
antibacterial agent
Moxifloxacindrug
antibacterial agent
Linezoliddrug
antibacterial agent