Cutaneous LeishmaniasesNCT04004754
Outcomes of Complicated CL in Ethiopia Treated With Miltefosine
An observational study of Cutaneous Leishmaniases, run by Institute of Tropical Medicine, Belgium at 2 sites in Ethiopia.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 years and older
- Conditions the study is for
- Cutaneous Leishmaniases
- What is being tested?
- Miltefosine (administration is not part of study procedures)
- How many people
- 94 participants
- Where
- 2 sitesEthiopia
- Study dates
- 7 May 2019to 11 Jun 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with complicated CL receiving miltefosine
Who may be able to join
- Parasitologically or clinically confirmed diagnosis of Leishmaniasis
- Clinical routine care decision to initiate miltefosine
Who cannot join
- Medical emergencies, underlying chronic conditions, or other circumstances that make participation in this study medically or otherwise inadvisable
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Documenting Clinical Outcomes of Patients Receiving Miltefosine for the Treatment of Complicated Cutaneous Leishmaniasis in Ethiopia
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
- Being tested
- Miltefosine (administration is not part of study procedures)
- Medical subject headings
- Leishmaniasis, Cutaneous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| Complicated CL in Gondar | Patients treated with miltefosine in Gondar will be followed up to see outcomes of treatment Receives: 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 Receives: Drug: Miltefosine (administration is not part of study procedures) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess final treatment response
proportion of index lesions with cure, good, partial and no treatment response
Measured: Day 90
Secondary outcomes (4)
Early and late treatment response
Proportion of index lesions with cure, good, partial and no treatment response at Day 28 and Day 180
Measured: Day 28, Day 180
Treatment failure
Proportion of index lesions with relapse or failure at Day 90 and Day 180
Measured: 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
Measured: Day 28
Predictors of cure
Covariate-adjusted risk ratios of factors associated with cure of index lesions at Day 90
Measured: Day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2019
- Study start7 May 2019
- Primary completion1 Apr 2020
- Study completion11 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cutaneous LeishmaniasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Tropical Medicine, Belgium
- Sponsor type
- University, hospital or other
- Collaborators
- University of Gondar, Boru Meda Hospital
- Responsible party
- Sponsor
- Investigators
- Johan van Griensven, MD,PhD, Study director, Institute of Tropical Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04004754
- Sponsor's protocol ID
- 1243/18
- Status last verified
- Jun 2020
- First submitted
- 26 Jun 2019
- Last updated
- 25 Jun 2020
- Results posted
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data can be made available to research by means of a managed access procedure
Publications
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.
PubMed 34048461
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Documenting Clinical Outcomes of Patients Receiving Miltefosine for the Treatment of Complicated Cutaneous Leishmaniasis in Ethiopia
- ClinicalTrials.gov ID
- NCT04004754
- Acronym / sponsor ID
- 1243/18
- Conditions
- Cutaneous Leishmaniases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Institute of Tropical Medicine, BelgiumUniversity, hospital or other
- Collaborators
- University of Gondar, Boru Meda Hospital
- Study start
- 7 May 2019 (actual)
- Primary completion
- 1 Apr 2020 (actual)
- Study completion
- 11 Jun 2020 (actual)
- First posted
- 2 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Complicated CL in Gondar | – | Drug: Miltefosine (administration is not part of study procedures)Patients treated with miltefosine in Gondar will be followed up to see outcomes of treatment |
| Complicated CL in Boru Meda | – | Drug: Miltefosine (administration is not part of study procedures)Patients treated with miltefosine in Boru Meda hospital will be followed up to see outcomes of treatment |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with complicated CL receiving miltefosine
Key inclusion criteria (2 listed)
- Parasitologically or clinically confirmed diagnosis of Leishmaniasis
- Clinical routine care decision to initiate miltefosine
Key exclusion criteria (1 listed)
- Medical emergencies, underlying chronic conditions, or other circumstances that make participation in this study medically or otherwise inadvisable
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Drug | Complicated CL in Boru Meda, Complicated CL in Gondar |
Primary outcome
Assess final treatment response
Time frame: Day 90
proportion of index lesions with cure, good, partial and no treatment response
4 secondary outcomes
Early and late treatment response
Time frame: Day 28, Day 180
Treatment failure
Time frame: Day 90, Day 180
Adherence
Time frame: Day 28
Predictors of cure
Time frame: Day 90
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2020.
- Derived from this study: PubMed 34048461van 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.
- Individual participant dataSharing planned: Yes. Data can be made available to research by means of a managed access procedure
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Johan van Griensven, MD,PhD study director
Institute of Tropical Medicine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cutaneous Leishmaniases, run by Institute of Tropical Medicine, Belgium at 2 sites in Ethiopia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Ethiopia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess final treatment response (time frame: Day 90). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04004754, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2020; AzTrials last refreshed its copy on 8 Nov 2026.