Outcomes of Complicated CL in Ethiopia Treated With Miltefosine

NCT ID: NCT04004754

Last Updated: 2020-06-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

94 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-05-07

Study Completion Date

2020-06-11

Brief Summary

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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.

Detailed Description

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Conditions

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Cutaneous Leishmaniases

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Complicated CL in Gondar

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

Miltefosine (administration is not part of study procedures)

Intervention Type 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

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

Miltefosine (administration is not part of study procedures)

Intervention Type DRUG

Patients who receive miltefosine in the routine setting will be asked to participate in the study to document their outcomes

Interventions

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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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

2 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Gondar

OTHER

Sponsor Role collaborator

Boru Meda Hospital

UNKNOWN

Sponsor Role collaborator

Institute of Tropical Medicine, Belgium

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Johan van Griensven, MD,PhD

Role: STUDY_DIRECTOR

Institute of Tropical Medicine

Locations

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Boru Meda Hospital

Boru, , Ethiopia

Site Status

Gondar University Hospital

Gonder, , Ethiopia

Site Status

Countries

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Ethiopia

References

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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.

Reference Type DERIVED
PMID: 34048461 (View on PubMed)

Other Identifiers

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1243/18

Identifier Type: -

Identifier Source: org_study_id

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