- Target disease: Cutaneous leishmaniasis (CL)
- Main partners (since project start): Instituto de Medicina Tropical Alexander von Humboldt, Universidad Peruana Cayetano Heredia, Lima, Peru; Programa de Estudio y Control de Enfermedades Tropicales, Universidad de Antioquia, Medellin, Colombia; Programa Nacional de Leishmaniasis, Colombia; Thermosurgery Technologies Inc, USA.
- Project Start: June 2015
- Funding (since project start):Department for International Development (DFID), UK; Dutch Ministry of Foreign Affairs (DGIS), The Netherlands; Federal Ministry of Education and Research (BMBF through KfW), Germany; Médecins Sans Frontières/Doctors without Borders, International; Swiss Agency for Development and Cooperation (SDC), Switzerland.
When administrated alone, the safety and efficacy profiles of current cutaneous leishmaniasis treatments (antimonials, miltefosine, and thermotherapy) are well established. Using a combination of therapeutic approaches may improve efficacy rates, reduce treatment duration, and improve the rate of adverse events. The Phase II study aims to assess whether a combination of thermotherapy with a shorter course of oral miltefosine achieves better results than thermotherapy alone.
Recruitment of patients was completed in Peru (65 patients) and in Colombia (65 patients). The last patient six-month follow-up is expected in early 2019. Interim results supported the preparation of a Phase III study in the Americas comparing the combination therapy (thermotherapy and miltefosine) against the standard treatment (meglumine antimoniate) which comes with risks of potential toxicity. The study is being planned in four countries in Latin America.
Recruitment of patients continued in Peru with the inclusion of 41 patients, and started in Colombia with the inclusion of 21 patients (out of 130 patients in total). An interim analysis is planned in early 2018 once 65 patients have completed the day 90 follow-up visit.
At the end of 2016, official approvals were obtained, a site initiation visit conducted and the first patients were enrolled in Peru, while final approvals are expected by early 2017 for a second site in Colombia.
Last update: August 2019