Outcomes of Complicated CL in Ethiopia Treated With Miltefosine

Completed

• Conditions: Cutaneous Leishmaniases
• Interventions: Drug: Miltefosine (administration is not part of study procedures)

• Registration Number: NCT04004754
• Lead Sponsor: Institute of Tropical Medicine, Belgium

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-05-07
• Study First Submitted: 2019-06-26
• Study First Submitted QC: 2019-07-01
• Study First Posted: 2019-07-02
• Primary Completion: 2020-04-01
• Status Verified: 2020-06
• Study Completion: 2020-06-11
• Last Update Submitted: 2020-06-23
• Last Update Posted: 2020-06-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 94

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Complicated CL in Boru Meda	Miltefosine (administration is not part of study procedures)	Patients treated with miltefosine in Boru Meda hospital will be followed up to see outcomes of treatment
Complicated CL in Gondar	Miltefosine (administration is not part of study procedures)	Patients treated with miltefosine in Gondar will be followed up to see outcomes of treatment

Primary Outcome Measures

Name	Time	Method
Assess final treatment response	Day 90	proportion of index lesions with cure, good, partial and no treatment response

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Boru Meda Hospital; 🇪🇹 Boru, Ethiopia

Gondar University Hospital; 🇪🇹 Gondar, Ethiopia