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

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.

Timeline

Start

2015-09

Primary completion

2017-04

Completion

2017-05

Outcome

Met primary endpoint

paper Lefamulin was noninferior to moxifloxacin for ECR (87.3% vs 90.2%, respectively; difference -2.9%, 95% confidence interval [CI] g -8.5 to 2.8) PMID 30722059 ↗

registry analysis (non-inferiority test); Lefamulin vs Moxifloxacin ± Linezolid; Treatment Difference (Lef - Mox) -2.9 (95% CI -8.5 to 2.8) NCT02559310 ↗

Publications

• File TM Jr, Alexander E, Goldberg L, Das AF, Sandrock C, Paukner S, Moran GJ. Lefamulin efficacy and safety in a pooled phase 3 clinical trial population with community-acquired bacterial pneumonia and common clinical comorbidities. BMC Pulm Med. 2021 May 8;21(1):154. doi: 10.1186/s12890-021-01472-z.
• File TM, Goldberg L, Das A, Sweeney C, Saviski J, Gelone SP, Seltzer E, Paukner S, Wicha WW, Talbot GH, Gasink LB. Efficacy and Safety of Intravenous-to-oral Lefamulin, a Pleuromutilin Antibiotic, for the Treatment of Community-acquired Bacterial Pneumonia: The Phase III Lefamulin Evaluation Against Pneumonia (LEAP 1) Trial. Clin Infect Dis. 2019 Nov 13;69(11):1856-1867. doi: 10.1093/cid/ciz090.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Lefamulin	Other / unclassified	150 mg	Intravenous
Comparator	Linezolid	Other / unclassified	—	—
Comparator	Moxifloxacin	Small molecule	400 mg	Intravenous

Indications

No indication recorded.