drugset / Trial / NCT02530697
The Association of Miltefosine and Pentoxifylline to Treat Mucosal and Cutaneous Leishmaniasis: A Clinical Trial in Brazil
RandomizedParallel-groupOpen-labelTreatment
Summary
Mucocutaneous leishmaniasis is endemic in the central region of Brazil and other countries worldwide. The standard treatment with meglumine antimoniate has a high rate of important adverse effects. This interventional study consists in a randomized clinical trial to access efficacy and safety of the association of miltefosine and pentoxifylline compared to meglumine antimoniate and pentoxifyline.
Timeline
- Start
- 2015-08
- Primary completion
- 2025-08
- Completion
- 2026-08
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Meglumine antimonate | Other / unclassified | 20 mg/kg | Intravenous |
| Subject | Miltefosine | Small molecule | 2.5 mg/kg | Oral |
| Subject | Miltefosine | Small molecule | 50 mg | Oral |
| Background | Pentoxifylline | Small molecule | 20 mg/kg | Oral |
| Background | Pentoxifylline | Small molecule | 400 mg | Oral |