Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| University of Gondar | OTHER |
| Boru Meda Hospital | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Complicated CL in Gondar | Patients treated with miltefosine in Gondar will be followed up to see outcomes of treatment |
| |
| Complicated CL in Boru Meda | Patients treated with miltefosine in Boru Meda hospital will be followed up to see outcomes of treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Miltefosine (administration is not part of study procedures) | Drug | Patients who receive miltefosine in the routine setting will be asked to participate in the study to document their outcomes |
| Measure | Description | Time Frame |
|---|---|---|
| Assess final treatment response | proportion of index lesions with cure, good, partial and no treatment response | Day 90 |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Patients with complicated CL receiving miltefosine
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Johan van Griensven, MD,PhD | Institute of Tropical Medicine | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boru Meda Hospital | Boru | Ethiopia | ||||
| Gondar University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34048461 | Derived | 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. |
Not provided
Not provided
Data can be made available to research by means of a managed access procedure
After completion of the primary publication
Managed access procedure - applicants need to fill out a data access request form
Not provided
| ID | Term |
|---|---|
| D016773 | Leishmaniasis, Cutaneous |
| ID | Term |
|---|---|
| D007896 | Leishmaniasis |
| D056986 | Euglenozoa Infections |
| D011528 | Protozoan Infections |
| D010272 | Parasitic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C039128 | miltefosine |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Routinely collected skin slit smears from the lesions were stored. Scrapings of these skin slit smears were analyzed by PCR and a selected group will be analyzed for species typing.
Patients could opt out of biospecimen storage and use for study purposes.
| 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 |
| Gonder |
| Ethiopia |
| D007239 |
| Infections |
| D012876 | Skin Diseases, Parasitic |
| D000079426 | Vector Borne Diseases |
| D012874 | Skin Diseases, Infectious |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |