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Outcomes of Complicated CL in Ethiopia Treated With Miltefosine

NCT04004754 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 94

Last updated 2020-06-25

No results posted yet for this study

Summary

Cutaneous Leishmaniasis in Ethiopia causes severe dermatological mutilations. Forms that require systemic treatment are cLCL, MCL, and DCL. National guidelines recommend equally all drugs that are also used for VL treatment. Miltefosine is one of these recommended medications but remains underused due to scarcity of drugs.

Outcomes of patients receiving miltefosine have never been documented systematically in Ethiopia until today. This is needed to provide evidence to advocate for increased access to miltefosine in Ethiopia, and to establish baseline data for future research on CL treatment options. The aim of this study is to document treatment outcomes of patients with cLCL, MCL, and DCL receiving systemic treatment using miltefosine within a routine care setting located in an endemic area in Ethiopia.

Conditions

  • Cutaneous Leishmaniases

Interventions

DRUG

Miltefosine (administration is not part of study procedures)

Patients who receive miltefosine in the routine setting will be asked to participate in the study to document their outcomes

Sponsors & Collaborators

  • University of Gondar

    collaborator OTHER

  • Boru Meda Hospital

    collaborator UNKNOWN

  • Institute of Tropical Medicine, Belgium

    lead OTHER

Principal Investigators

  • Johan van Griensven, MD,PhD · Institute of Tropical Medicine

Eligibility

Min Age
2 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-07
Primary Completion
2020-04-01
Completion
2020-06-11

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 NCT04004754 on ClinicalTrials.gov