Outcomes of Complicated CL in Ethiopia Treated With Miltefosine
NCT ID: NCT04004754
Last Updated: 2020-06-25
Study Results
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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COMPLETED
94 participants
OBSERVATIONAL
2019-05-07
2020-06-11
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
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)
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)
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
Eligibility Criteria
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Inclusion Criteria
* Clinical routine care decision to initiate miltefosine
Exclusion Criteria
2 Years
ALL
No
Sponsors
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University of Gondar
OTHER
Boru Meda Hospital
UNKNOWN
Institute of Tropical Medicine, Belgium
OTHER
Responsible Party
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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
Gondar University Hospital
Gonder, , Ethiopia
Countries
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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.
Other Identifiers
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1243/18
Identifier Type: -
Identifier Source: org_study_id
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