Outcomes of Complicated CL in Ethiopia Treated With Miltefosine

NCT04004754 | Completed

• 1 other identifier: 1243/18
• Study Type: observational
• Target: 94
• Locations: 1 country
• Sites: 2

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.

Conditions

Cutaneous Leishmaniases

Outcome Measures

Primary Outcomes (1)

• Assess final treatment response

  proportion of index lesions with cure, good, partial and no treatment response

  Day 90

Secondary Outcomes (4)

• Early and late treatment response

  Day 28, Day 180

• Treatment failure

  Day 90, Day 180

• Adherence

  Day 28

• Predictors of cure

  Day 90

Study Arms (2)

Complicated CL in Gondar

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

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

Complicated CL in Boru Meda

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

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

Interventions

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

Complicated CL in Boru Meda; Complicated CL in Gondar

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with complicated CL receiving miltefosine

You may qualify if:

• Parasitologically or clinically confirmed diagnosis of Leishmaniasis
• Clinical routine care decision to initiate miltefosine

You may not qualify if:

• Medical emergencies, underlying chronic conditions, or other circumstances that make participation in this study medically or otherwise inadvisable

Sponsors & Collaborators

• Institute of Tropical Medicine, Belgium: lead
• University of Gondar: collaborator
• Boru Meda Hospital: collaborator

Study Sites (2)

Boru Meda Hospital

Boru, Ethiopia

Location

Gondar University Hospital

Gonder, Ethiopia

Location

Related Publications (1)

• 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.

  PMID: 34048461 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

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.

MeSH Terms

Conditions

Leishmaniasis, Cutaneous

Interventions

miltefosine

Condition Hierarchy (Ancestors)

Leishmaniasis; Euglenozoa Infections; Protozoan Infections; Parasitic Diseases; Infections; Skin Diseases, Parasitic; Vector Borne Diseases; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Johan van Griensven, MD,PhD

  Institute of Tropical Medicine

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2019
• First Posted: July 2, 2019
• Study Start: May 7, 2019
• Primary Completion: April 1, 2020
• Study Completion: June 11, 2020
• Last Updated: June 25, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After completion of the primary publication
• Access Criteria: Managed access procedure - applicants need to fill out a data access request form

Locations

ET (2)