Optimizing Miltefosine Treatment for Cutaneous Leishmaniasis in Children and Adults Studying Parasite and Drug Levels During 4 to 8 Weeks of Therapy

What this Trial Is About

Researchers are studying cutaneous leishmaniasis CL to better understand how miltefosine works in treating this skin condition. The study focuses on how the parasite clears from the body and how the drug is absorbed and distributed during treatment. This research aims to improve miltefosine dosing and treatment duration, especially for children and patients in Ethiopia, as current 28-day treatments may not be sufficient. The study observes two groups of patients one group weighing 30 kg or more will receive miltefosine based on weight 100 mg or 150 mg daily, while the other group, weighing less than 30 kg, will receive an allometric dose adjusted for weight, height, and sex. Treatment lasts a minimum of four weeks and can be extended up to eight weeks depending on response. The study will measure miltefosine concentrations in the blood and skin over time to understand drug levels and parasite dynamics. Participants will be closely monitored through blood and skin tests at multiple time points, from the start of treatment up to 180 days. Researchers will assess parasite levels, drug concentration, treatment outcomes, safety, and explore factors like resistance, nutritional status, and other infections that might affect treatment. Participants will provide informed consent and stay hospitalized during treatment. This detailed monitoring will help optimize dosing strategies for future patients.

OPTImizing MIltefosine Treatment for Cutaneous LEISHmaniasis Patients