drugset / Trial / NCT02813694
Study to Compare Lefamulin to Moxifloxacin for the Treatment of Adults With Pneumonia
RandomizedParallel-groupQuadruple-blindTreatment
Summary
This study evaluates the safety and efficacy of lefamulin, a pleuromutilin, for the treatment of adults with moderate community-acquired bacterial pneumonia
Timeline
- Start
- 2016-08
- Primary completion
- 2018-01
- Completion
- 2018-01
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.
- Alexander E, Goldberg L, Das AF, Moran GJ, Sandrock C, Gasink LB, Spera P, Sweeney C, Paukner S, Wicha WW, Gelone SP, Schranz J. Oral Lefamulin vs Moxifloxacin for Early Clinical Response Among Adults With Community-Acquired Bacterial Pneumonia: The LEAP 2 Randomized Clinical Trial. JAMA. 2019 Nov 5;322(17):1661-1671. doi: 10.1001/jama.2019.15468.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Lefamulin | Other / unclassified | 600 mg | Oral |
| Comparator | Moxifloxacin | Small molecule | 400 mg | Oral |
Indications
No indication recorded.