Outcomes of Complicated CL in Ethiopia Treated With Miltefosine

Institute of Tropical Medicine, Belgium

Status: Completed

Conditions: Cutaneous Leishmaniases

Treatments: Drug: Miltefosine (administration is not part of study procedures)

Study type: Observational

Funder types: Other

Identifiers

NCT04004754

1243/18

Details and patient eligibility

About

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.

Enrollment: 94 patients

Sex: All

Ages: 2+ years old

Volunteers: No Healthy Volunteers

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

Trial design

94 participants in 2 patient groups

Complicated CL in Gondar

Description:

Patients treated with miltefosine in Gondar will be followed up to see outcomes of treatment

Treatment:

Drug: Miltefosine (administration is not part of study procedures)

Complicated CL in Boru Meda

Description:

Patients treated with miltefosine in Boru Meda hospital will be followed up to see outcomes of treatment

Treatment:

Drug: Miltefosine (administration is not part of study procedures)