drugset / Trial / NCT04799236
Treatment of Mucosal Bolivian Leishmaniasis
Phase 3
Unknown
120 enrolled
Fundacion Nacional de Dermatologia
ABF Foundation for Medical Research · collabCentro Nacional de Enfermedades Tropicales CENETROP · collabHospital Dermatológico de Jorochito · collab
RandomizedParallel-groupSingle-blindTreatment
Summary
The purpose of this protocol is to conduct a randomized comparison of the efficacy and tolerance of miltefosine, LAMB, and pentavalent antimony for the treatment of mucosal leishmaniasis. With such controlled pharmacodynamic data, and additional considerations of administrative convenience (oral \>\>IV) and cost, we hope that it will be possible for policy makers, treatment professionals, and patients to choose the most appropriate therapy for ML.
Timeline
- Start
- 2021-04-01
- Primary completion
- 2024-04-30
- Completion
- 2024-11-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Amphotericin B | Unknown | 150 mg | Intravenous |
| Comparator | Meglumine antimonate | Other / unclassified | 20 mg/kg | Intravenous |
| Comparator | Miltefosine | Small molecule | 50 mg | Oral |