Outcomes of Complicated CL in Ethiopia Treated With Miltefosine

Study Overview
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Brief Summary
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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.

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

Conditions
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Cutaneous Leishmaniases

Intervention / Treatment
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* Drug: Miltefosine (administration is not part of study procedures)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 2 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Complicated CL in Gondar<br>Patients treated with miltefosine in Gondar will be followed up to see outcomes of treatment | Drug: Miltefosine (administration is not part of study procedures)<br>* Patients who receive miltefosine in the routine setting will be asked to participate in the study to document their outcomes<br>|
| Complicated CL in Boru Meda<br>Patients treated with miltefosine in Boru Meda hospital will be followed up to see outcomes of treatment | Drug: Miltefosine (administration is not part of study procedures)<br>* Patients who receive miltefosine in the routine setting will be asked to participate in the study to document their outcomes<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess final treatment response | proportion of index lesions with cure, good, partial and no treatment response | Day 90 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Early and late treatment response | Proportion of index lesions with cure, good, partial and no treatment response at Day 28 and Day 180 | Day 28, Day 180 | 
| Treatment failure | Proportion of index lesions with relapse or failure at Day 90 and Day 180 | Day 90, Day 180 | 
| Adherence | Proportion of patients with excellent (0 missed), good (1-3 missed), mediocre (4-8 missed), and poor (<=9 missed) adherence | Day 28 | 
| Predictors of cure | Covariate-adjusted risk ratios of factors associated with cure of index lesions at Day 90 | Day 90 |