Optimizing miltefosine treatment for cutaneous leishmaniasis
Official title: OPTImizing MIltefosine Treatment for Cutaneous LEISHmaniasis Patients
Run by Institute of Tropical Medicine, Belgium · NCT06514560 · Data updated 2026-11-12
This study tests if adjusting the miltefosine treatment can help kids with cutaneous leishmaniasis get better by looking at how the drug and the parasite behave in their bodies over a few weeks.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 2 Years and up |
| Sex | All |
| Enrollment | 80 (estimated) |
| Sponsor | Institute of Tropical Medicine, Belgium Academic / other |
| Locations | 1 site (Addis Ababa) |
| Status | Recruiting |
| Started | June 18, 2024 |
| Main results expected | December 30, 2025 |
| Study ends | December 30, 2026 |
| Registry record updated | July 23, 2024 |
| Trial ID | NCT06514560 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include individuals aged over 2 years with confirmed cutaneous leishmaniasis who are starting miltefosine treatment.
✕Probably not a fit
Patients currently receiving treatment for leishmaniasis or those with severe abnormal lab values may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study investigates the effectiveness of miltefosine treatment for cutaneous leishmaniasis, particularly focusing on the parasite dynamics and drug pharmacokinetics over a treatment period of 4-8 weeks. By conducting longitudinal measurements of parasite and drug concentrations in both skin and blood, the research aims to provide evidence for optimizing miltefosine dosing, especially in pediatric patients. The study also explores additional factors that may influence treatment response, such as resistance and nutritional status, to enhance outcome assessments.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment protocols for cutaneous leishmaniasis, particularly benefiting children and enhancing global health outcomes.
How similar studies have gone: While there is limited data on optimizing miltefosine specifically for cutaneous leishmaniasis, similar pharmacokinetic studies have shown promise in improving treatment outcomes for other conditions.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Africa Leprosy, Tuberculosis, Rehabilitation and Training (ALERT) Hospital
Addis Ababa, Ethiopia Recruiting
Study contacts
- Principal investigator: Saskia Van Henten — Institute of Tropical Medicine
- Study coordinator: Shimelis Nigusse, MD
- Email: shimelis321@gmail.com
- Phone: 0911642060
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Eliminating Gambiense sleeping sickness using a single-dose oral treatment in screened seropositive people
This trial tests whether giving a single dose of acoziborole to people who test positive in screening for Gambiense human African trypanosomiasis can reduce disease transmission over three years.
-
Immunogenicity screening of Leishmania vaccine candidate antigens in Ethiopian patients
This study tests whether six Leishmania vaccine candidate antigens can trigger T-cell responses in patients with cutaneous or visceral leishmaniasis.
-
Baseline skin memory T cells in unvaccinated volunteers
This study tests the natural baseline levels of skin-resident memory T cells in healthy people who have not received the yellow fever vaccine.
-
Recurrent visceral leishmaniasis in people living with HIV
This project will follow adults living with HIV who develop visceral leishmaniasis to see if differences in the patient or the parasite explain why some people have repeated relapses.
-
Improving care and surveillance of fevers in the DRC
This project tracked people with recent fevers at two hospitals in the DRC to see what causes their fevers, how they are treated, and whether biomarkers like CRP relate to outcomes and antibiotic use.
-
Controlling Aedes mosquitoes in Kinshasa
This study is testing different ways to control Aedes mosquitoes in Kinshasa to see if it helps reduce the spread of diseases like dengue and chikungunya.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.