OPTImizing MIltefosine Treatment for Cutaneous LEISHmaniasis Patients (OPTIMILEISH)

Institute of Tropical Medicine, Belgium

Status: Enrolling

Conditions: Cutaneous Leishmaniases

Treatments: Drug: Miltefosine

Study type: Observational

Funder types: Other

Identifiers

NCT06514560

1708/23

Details and patient eligibility

About

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.

Full description

In this project, parasite dynamics and miltefosine pharmacokinetics in the skin and blood during routine durations of miltefosine treatment (4-8 weeks) are studied with the aim to provide evidence to optimize miltefosine dosing for treatment of CL. By also studying these factors in children who get allometric miltefosine dosing, data which can be used to adapt the current allometric dosing scheme specifically to children with CL will be produced. Exploratory objectives will look into searching for more objective outcome assessment measures, resistance, helminth infection and nutritional status as potential factors affecting treatment response.

Enrollment: 80 estimated patients

Sex: All

Ages: 2+ years old

Volunteers: No Healthy Volunteers

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

Trial design

80 participants in 2 patient groups

Non-allometric dosing

Description:

40 patients who will not use allometric dosing will be included miltefosine will be given based on weight: 30-45 kg: 100mg miltefosine per day \>45 kg: 150mg miltefosine per day

Treatment:

Drug: Miltefosine

allometric dosing (weight below 30 kg)

Description:

40 patients who weigh less than 30kg and therefore get allometric dosing will be recruited. Dosing is given based on weight, height, and sex, according to Dorlo et al 2012

Treatment:

Drug: Miltefosine