OPTImizing MIltefosine Treatment for Cutaneous LEISHmaniasis Patients

Recruiting now

Conditions studied: Cutaneous Leishmaniases

In brief

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.

Key facts

Study ID: NCT06514560
Run by: Institute of Tropical Medicine, Belgium
People needed: 80
Starts: 2024-06-18
Expected to finish: 2026-12-30
Last updated by the study team: 2024-07-23

Who can join

Age: 2 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

Africa Leprosy, Tuberculosis, Rehabilitation and Training (ALERT) Hospital — Addis Ababa, Ethiopia (enrolling)

Full record on ClinicalTrials.gov

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