OPTImizing MIltefosine Treatment for Cutaneous LEISHmaniasis Patients
Institute of Tropical Medicine, Belgium
80 participants
Jun 18, 2024
OBSERVATIONAL
Conditions
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.
Eligibility
Inclusion Criteria6
- 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 Criteria4
- 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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Interventions
Miltefosine will be prescribed by the treating physician for a minimum of 4 weeks. If treatment response is not sufficient, treatment extension could be decided by the treating physician up to 8 weeks
Locations(1)
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NCT06514560