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OpenTrials
Completed

NCT Number: NCT04004754

Outcomes of Complicated CL in Ethiopia Treated With Miltefosine

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.

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Key information

Conditions

Cutaneous Leishmaniases Euglenozoa Infections Infections Leishmaniasis Leishmaniasis, Cutaneous Parasitic Diseases Protozoan Infections Skin Diseases Skin Diseases, Infectious Skin Diseases, Parasitic Skin and Connective Tissue Diseases Vector Borne Diseases

Age range

2 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Boru Meda Hospital, Boru, Ethiopia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Parasitologically or clinically confirmed diagnosis of Leishmaniasis
  • Clinical routine care decision to initiate miltefosine

Exclusion criteria

  • Medical emergencies, underlying chronic conditions, or other circumstances that make participation in this study medically or otherwise inadvisable

Treatment and study plan

Miltefosine (administration is not part of study procedures)

Drug

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

Primary outcomes

  1. Assess final treatment response

    Time frame: Day 90

    proportion of index lesions with cure, good, partial and no treatment response

Secondary outcomes

  1. Early and late treatment response

    Time frame: Day 28, Day 180

    Proportion of index lesions with cure, good, partial and no treatment response at Day 28 and Day 180

  2. Treatment failure

    Time frame: Day 90, Day 180

    Proportion of index lesions with relapse or failure at Day 90 and Day 180

  3. Adherence

    Time frame: Day 28

    Proportion of patients with excellent (0 missed), good (1-3 missed), mediocre (4-8 missed), and poor (<=9 missed) adherence

  4. Predictors of cure

    Time frame: Day 90

    Covariate-adjusted risk ratios of factors associated with cure of index lesions at Day 90

Sponsors and collaborators

Lead sponsor

Institute of Tropical Medicine, Belgium

Other

Collaborators

  • Boru Meda Hospital
  • University of Gondar

Registry information

Official study title

Documenting Clinical Outcomes of Patients Receiving Miltefosine for the Treatment of Complicated Cutaneous Leishmaniasis in Ethiopia

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jul 2, 2019
Registry last updated
Jun 25, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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