Optimizing miltefosine treatment for cutaneous leishmaniasis
OPTImizing MIltefosine Treatment for Cutaneous LEISHmaniasis Patients
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 |
|---|---|
| Enrollment | 80 (estimated) |
| Ages | 2 Years and up |
| Sex | All |
| Sponsor | Institute of Tropical Medicine, Belgium Academic / other |
| Locations | 1 site (Addis Ababa) |
| Trial ID | NCT06514560 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include individuals aged over 2 years with confirmed cutaneous leishmaniasis who are starting miltefosine treatment.
Not a fit: Patients currently receiving treatment for leishmaniasis or those with severe abnormal lab values may not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Addis Ababa
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.