NCT02813694

Study to Compare Lefamulin to Moxifloxacin for the Treatment of Adults With Pneumonia

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 738 (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 community-acquired bacterial pneumonia

Detailed description

Lefamulin is a potent, semi-synthetic antibacterial belonging to a novel class known as the pleuromutilins. The oral dosage form of lefamulin is 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

Timeline

• Start date: 2016-08-01
• Primary completion: 2018-01-01
• Completion: 2018-01-01
• First posted: 2016-06-27
• Last updated: 2019-10-23
• Results posted: 2019-10-23

Locations

155 sites across 20 countries: United States, Argentina, Brazil, Bulgaria, Chile, Georgia, Hungary, Latvia, Mexico, Peru, Philippines, Poland, Romania, Russia, Serbia, South Africa, South Korea, Spain, Taiwan, Ukraine