Cutaneous Leishmaniases
Conditions
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.
Interventions
DRUGMiltefosine (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
Sponsors
University of Gondar
Boru Meda Hospital
Institute of Tropical Medicine, Belgium
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
2 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assess final treatment response | Day 90 | proportion of index lesions with cure, good, partial and no treatment response |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Treatment failure | Day 90, Day 180 | Proportion of index lesions with relapse or failure at Day 90 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 |
| Predictors of cure | Day 90 | Covariate-adjusted risk ratios of factors associated with cure of index lesions at Day 90 |
Countries
Ethiopia
Outcome results
None listed