NCT02559310

Study to Compare Lefamulin to Moxifloxacin (With or Without Linezolid) for the Treatment of Adults With Pneumonia

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: Phase 3
• Study type: Interventional
• Enrollment: 551 (actual)
• Sponsor: Nabriva Therapeutics AG · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Lefamulin is a potent, semi-synthetic antibacterial belonging to a novel class known as the pleuromutilins. Both the intravenous (IV) and oral dosage forms of lefamulin are under investigation in this study. Lefamulin's in vitro antibacterial profile includes the most important bacterial pathogens causing respiratory tract infection (RTI). The antibacterial spectrum comprises S. pneumoniae, H. influenzae, M. catarrhalis, the atypical respiratory pathogens L. pneumophila, C. pneumoniae, and M. pneumoniae, S. aureus including MRSA and CA-MRSA, ß-haemolytic streptococci including S. pyogenes and S. agalactiae, and Enterococcus faecium including vancomycin-resistant enterococci (VRE). Moreover, as demonstrated in cross-resistance studies, lefamulin remains active against clinical isolates resistant to the following antimicrobial(s) (classes): macrolides, lincosamides, streptogramin B, oxazolidinones, tetracyclines, ß lactams, quinolones, trimethoprim-sulfametoxazole, mupirocin, and vancomycin.

Conditions

• Community Acquired Pneumonia

Interventions

Type	Name	Description
DRUG	lefamulin	antibacterial agent
DRUG	Moxifloxacin	antibacterial agent
DRUG	Linezolid	antibacterial agent

Timeline

• Start date: 2015-09-01
• Primary completion: 2017-04-01
• Completion: 2017-05-01
• First posted: 2015-09-24
• Last updated: 2019-10-23
• Results posted: 2019-10-23

Locations

99 sites across 18 countries: United States, Argentina, Bosnia and Herzegovina, Brazil, Bulgaria, Georgia, Hungary, Latvia, Netherlands, Peru, Philippines, Poland, Romania, Russia, Serbia, South Africa, Thailand, Ukraine