6 completed, 1 terminated. 4 Phase 1, 2 Phase 2, 2 Phase 3.
| Phase | Trials | Status |
|---|---|---|
| Phase 1 | 4 | Completed 3, Terminated 1 |
| Phase 2 | 2 | Completed 1, Terminated 1 |
| Phase 3 | 2 | Completed 2 |
Follow lefamulin: new trials by email Literature Review of lefamulin trials Research Report on lefamulin
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Lefamulin for M. Genitalium Treatment Failures Lefamulin, Doxycycline - Mycoplasma Genitalium Infection | Phase 1 / Phase 2 | Terminated | University of Washington | 12 | 2022-04-22 | 2024-10-26 |
| Study to Assess the Safety and PK of Oral and IV Xenleta in Adults With Cystic Fibrosis Lefamulin - Cystic Fibrosis | Phase 1 | Completed | Nabriva Therapeutics AG | 13 | 2022-03-01 | 2024-06-17 |
| A Study to Assess Mass Balance Recovery, Metabolite Profile and Identification of IV and Oral 14C-BC-3781 BC-3781 - Healthy | Phase 1 | Completed | Nabriva Therapeutics AG | 10 | 2017-01-08 | 2018-04-03 |
| Study to Compare Lefamulin to Moxifloxacin for the Treatment of Adults With Pneumonia lefamulin, Moxifloxacin - Community Acquired Pneumonia | Phase 3 | Completed | Nabriva Therapeutics AG | 738 | 2016-08-01 | 2019-10-23 |
| Study to Compare Lefamulin to Moxifloxacin (With or Without Linezolid) for the Treatment of Adults With Pneumonia lefamulin, Moxifloxacin, Linezolid - Community Acquired Pneumonia | Phase 3 | Completed | Nabriva Therapeutics AG | 551 | 2015-09-01 | 2019-10-23 |
| Bioavailability and Pharmacokinetics of Lefamulin When Administered to Fed and Fasted Healthy Subjects Lefamulin - Healthy | Phase 1 | Completed | Nabriva Therapeutics AG | 20 | 2015-06-01 | 2015-09-23 |
| Study Comparing the Safety and Efficacy of Two Doses of BC-3781 vs Vancomycin in Patients With Acute Bacterial Skin and Skin Structure Infection (ABSSSI) BC-3781, Vancomycin - Bacterial Infections, Infection | Phase 2 | Completed | Nabriva Therapeutics AG | 210 | 2010-05-01 | 2020-11-17 |
Community-Acquired Pneumonia (2) · Pneumonia (2) · Bacterial Infections (1) · Cystic Fibrosis (1) · Infections (1)
Nabriva Therapeutics AG (6) · University of Washington (1)
United States (5) · Argentina (2) · Brazil (2) · Bulgaria (2) · Georgia (2) · Hungary (2) · Latvia (2) · Peru (2) · Philippines (2) · Poland (2) · Romania (2) · Russia (2) · Serbia (2) · South Africa (2) · Ukraine (2)
Elyse Seltzer, MD (1) · Jennifer Schranz, MD (1) · Leanne Gasink, MD (1) · Lisa E Manhart, PhD, MPH (1) · William T Prince, MB, BChir (1) · William T. Prince, Dr. (1)
PMID 33964925, PMID 25348519, PMID 30722059, PMID 31560372, PMID 38195348