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OPTImizing MIltefosine Treatment for Cutaneous LEISHmaniasis Patients

Recruitingn/aAges 2 Years - anyAllInstitute of Tropical Medicine, Belgium
NCT06514560 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: * Clinical or parasitological (microscopy or PCR) confirmation of leishmaniasis * Age \>2 * Clinical decision to start miltefosine treatment as systemic treatment * In case of females of child-bearing age: willing to take contraceptive for 6 months (parenteral or IUD or implant) * Willing and able to provide informed consent * Willing to be hospitalized for the duration of treatment Exclusion Criteria: * Currently on treatment or having received modern treatment for leishmaniasis in the last 3 months * Pregnant (pregnancy test at D0) or breastfeeding * Unlikely to come for follow-up visits * Abnormal lab values Hemoglobin \<5.0g/100mL Platelets \<50 x 10\^9/L White blood count \<1 x 10\^9/L ASAT/ALAT \>3x upper normal range Creatinine above the normal limit
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What it tests

  • Miltefosine
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Where

1 site
Africa Leprosy, Tuberculosis, Rehabilitation and Training (ALERT) Hospital
Addis Ababa, Ethiopia
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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