NCT04004754

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 94 (actual)
• Sponsor: Institute of Tropical Medicine, Belgium · Academic / Other
• Sex: All
• Age: 2 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cutaneous Leishmaniases

Interventions

Type	Name	Description
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

Timeline

• Start date: 2019-05-07
• Primary completion: 2020-04-01
• Completion: 2020-06-11
• First posted: 2019-07-02
• Last updated: 2020-06-25

Locations

2 sites across 1 country: Ethiopia