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OPTImizing MIltefosine Treatment for Cutaneous LEISHmaniasis Patients

NCT06514560 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 80

Last updated 2024-07-23

No results posted yet for this study

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.

Conditions

  • Cutaneous Leishmaniases

Interventions

DRUG

Miltefosine

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

Sponsors & Collaborators

  • Alert Hospital, Ethiopia

    collaborator OTHER

  • Armauer Hansen Research Institute, Ethiopia

    collaborator OTHER

  • Uppsala University

    collaborator OTHER

  • The Netherlands Cancer Institute

    collaborator OTHER

  • Institute of Tropical Medicine, Belgium

    lead OTHER

Principal Investigators

  • Saskia Van Henten · Institute of Tropical Medicine

Eligibility

Min Age
2 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-18
Primary Completion
2025-12-30
Completion
2026-12-30

Countries

  • Ethiopia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06514560 on ClinicalTrials.gov