Outcomes of Complicated CL in Ethiopia Treated With Miltefosine

Cutaneous Leishmaniases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04004754
• Other study ID #: 1243/18
• Status: Completed
• Start date: May 7, 2019
• Est. completion date: June 11, 2020

Study information

• Verified date: June 2020
• Source: Institute of Tropical Medicine, Belgium
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 94
• Est. completion date: June 11, 2020
• Est. primary completion date: April 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cutaneous Leishmaniases
• Leishmaniasis
• Leishmaniasis, Cutaneous

Intervention

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

Locations

Country	Name	City	State
Ethiopia	Boru Meda Hospital	Boru
Ethiopia	Gondar University Hospital	Gondar

Sponsors (3)

Lead Sponsor	Collaborator
Institute of Tropical Medicine, Belgium	Boru Meda Hospital, University of Gondar

Country where clinical trial is conducted

Ethiopia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assess final treatment response	proportion of index lesions with cure, good, partial and no treatment response	Day 90
Secondary	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
Secondary	Treatment failure	Proportion of index lesions with relapse or failure at Day 90 and Day 180	Day 90, Day 180
Secondary	Adherence	Proportion of patients with excellent (0 missed), good (1-3 missed), mediocre (4-8 missed), and poor (<=9 missed) adherence	Day 28
Secondary	Predictors of cure	Covariate-adjusted risk ratios of factors associated with cure of index lesions at Day 90	Day 90