Outcomes of Complicated CL in Ethiopia Treated With Miltefosine

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

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.

Study Overview

• Status: Completed
• Conditions: Cutaneous Leishmaniases
• Intervention / Treatment: Drug: Miltefosine (administration is not part of study procedures)

• Study Type: Observational
• Enrollment (Actual): 94

Contacts and Locations

Study Locations

• Ethiopia
  • Boru, Ethiopia
    • Boru Meda Hospital
  • Gondar, Ethiopia
    • Gondar University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients with complicated CL receiving miltefosine

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Complicated CL in Gondar; Patients treated with miltefosine in Gondar will be followed up to see outcomes of treatment	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
Complicated CL in Boru Meda; 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); Patients who receive miltefosine in the routine setting will be asked to participate in the study to document their outcomes

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Institute of Tropical Medicine, Belgium
• Collaborators: University of Gondar; Boru Meda Hospital
• Investigators: Study Director: Johan van Griensven, MD,PhD, Institute of Tropical Medicine

Publications and helpful links

General Publications

• van Henten S, Tesfaye AB, Abdela SG, Tilahun F, Fikre H, Buyze J, Kassa M, Cnops L, Pareyn M, Mohammed R, Vogt F, Diro E, van Griensven J. Miltefosine for the treatment of cutaneous leishmaniasis-A pilot study from Ethiopia. PLoS Negl Trop Dis. 2021 May 28;15(5):e0009460. doi: 10.1371/journal.pntd.0009460. eCollection 2021 May.

Study record dates

Study Major Dates

• Study Start (Actual): May 7, 2019
• Primary Completion (Actual): April 1, 2020
• Study Completion (Actual): June 11, 2020

Study Registration Dates

• First Submitted: June 26, 2019
• First Submitted That Met QC Criteria: July 1, 2019
• First Posted (Actual): July 2, 2019

Study Record Updates

• Last Update Posted (Actual): June 25, 2020
• Last Update Submitted That Met QC Criteria: June 23, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Infections; Vector Borne Diseases; Parasitic Diseases; Protozoan Infections; Skin Diseases, Parasitic; Skin Diseases, Infectious; Euglenozoa Infections; Leishmaniasis; Leishmaniasis, Cutaneous; Anti-Infective Agents; Antineoplastic Agents; Antifungal Agents; Antiprotozoal Agents; Antiparasitic Agents; Miltefosine
• Other Study ID Numbers: 1243/18

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data can be made available to research by means of a managed access procedure
• IPD Sharing Time Frame: After completion of the primary publication
• IPD Sharing Access Criteria: Managed access procedure - applicants need to fill out a data access request form
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated device product: No