OPTImizing MIltefosine Treatment for Cutaneous LEISHmaniasis Patients

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 2
View:

• 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

Locations
Other Locations
Ethiopia
Africa Leprosy, Tuberculosis, Rehabilitation and Training (ALERT) Hospital
RECRUITING
Addis Ababa
Contact Information
Primary
Shimelis Nigusse, MD
shimelis321@gmail.com
0911642060
Time Frame
Start Date: 2024-06-18
Estimated Completion Date: 2026-12-30
Participants
Target number of participants: 80
Treatments
Non-allometric dosing
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
allometric dosing (weight below 30 kg)
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
Related Therapeutic Areas
Sponsors
Collaborators: The Netherlands Cancer Institute, Alert Hospital, Ethiopia, Armauer Hansen Research Institute, Ethiopia, Uppsala University
Leads: Institute of Tropical Medicine, Belgium

This content was sourced from clinicaltrials.gov

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