Clinical Trial

OPTImizing MIltefosine Treatment for Cutaneous LEISHmaniasis Patients

Study acronym: OPTIMILEISH
Recruiting
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Record status
This record was last updated July 23, 2024 (before its estimated December 30, 2025 completion). Its status may not reflect the trial's current state.
Summary
While there are indications that 28 days of miltefosine is not sufficient for treating CL by L. aethiopica, a better understanding of what happens in terms of parasite clearance and drug dosing is lacking. In this study, longitudinal measurements of parasite and drug concentrations during treatment are done to monitor parasite kinetics as well as pharmacokinetics. This data will be crucial to provide more information on duration and dosing of miltefosine in CL patients globally, and in Ethiopia and pediatric patients in particular.
Trial Details
NCT Number NCT06514560
Lead Sponsor Institute of Tropical Medicine, Belgium
Collaborators: Alert Hospital, Ethiopia, Armauer Hansen Research Institute, Ethiopia, Uppsala University, The Netherlands Cancer Institute
Conditions Cutaneous Leishmaniases
Enrollment 80 participants
Start Date 2024-06-18
Primary Completion 2025-12-30 (estimated)
Study Completion 2026-12-30 (estimated)
Updated on ClinicalTrials.gov 2024-07-23