Cutaneous LeishmaniasesMILT2022NCT05493059
Study of Cases of Cutaneous Leishmaniasis Treated With Miltefosine in French Guiana, Retrospective Study
An observational study of Cutaneous Leishmaniases and Treatment Adherence, run by Centre Hospitalier de Cayenne.
Trial summary
Miltefosine is the only oral treatment currently available for Cutaneous Leishmaniasis. Despite several reports of good efficiency in other countries of South America, miltefosine remains limited to a compassionate use in France. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cutaneous Leishmaniases, Treatment Adherence, Primary Health Care
- What is being tested?
- Data collection and Questionnaires
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 8 Aug 2022to 8 Oct 2022
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients presenting Mucocutaneous Leishmaniasis proven by culture and/or polymerase chain reaction (PCR) seen in French Guiana between 01/01/2017 and 01/04/2022, in dispensaries (CDPS) or in the Dermatology Department of the CHC and having received treatment with Miltefosine
Who may be able to join
- Mucocutaneous Leishmaniasis proven by culture and/or polymerase chain reaction (PCR)
- Seen in French Guiana between 01/01/2017 and 01/04/2022, in dispensaries (CDPS) or in the Dermatology Department of the CHC
- Having received treatment with Miltefosine
- Patient who consented to participate in the study
- Age equal or superior to 18 years
Who cannot join
- Clinically suspected but not parasitologically proven leishmaniasis
- Refusal to participate
- Age < 18
- Patient under legal guardianship
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Study of Cases of Cutaneous Leishmaniasis Treated With Miltefosine in French Guiana, Retrospective Study Before Clinical Trial (MILT 2022)
Miltefosine is the only oral treatment currently available for Cutaneous Leishmaniasis.
Despite several reports of good efficiency in other countries of South America, miltefosine remains limited to a compassionate use in France. The objective of this study is to collect data regarding the efficacy, safety and acceptability of miltefosine in patients treated in French Guiana since 2017.
Read the detailed description
In French Guiana, Cutaneous Leishmaniasis is mostly caused by Leishmania guyanensis (80% of cases), followed by L. braziliensis (10%) and rarer species. L. guyanensis is usually treated with a single injection of pentamidine. However, pentamidine-resistant infections (10%) and all L. braziliensis are treated with either amphotericine B or meglumine antimoniate. These treatments can only be used during an hospitalization, which is the source of important indirect costs and discomforts for patients from the remote areas of French Guiana. Miltefosine is the only oral treatment available for Cutaneous Leishmaniasis. While it is widely used in South America (with good reported efficacy), the data available in France are scarce. This treatment, if available on a larger scale in France, would allow a treatment without hospitalization, which would be very suitable for French Guianese patients.
Our objective is to collect data on patients already treated with miltefosine in French Guiana (current indications being failure, side effect or impossible delivery of amphotericine B and meglumine antimoniate) in order to assess its efficacy, safety and acceptability. Patients treated with miltefosine at the Cayenne Hospital Center between 2017 and 2022 will be contacted by phone so as to answer questions regarding their quality of life during the infection and their satisfaction concerning miltefosine as a treatment. Data on their symptoms and general informations will be extracted from the medical files.
Primary objective: To assess the efficacy, tolerance and acceptability of Miltefosine among patients already treated with this drug as part of its AAC in French Guiana.
Observational, retrospective and prospective, monocentric study Research Involving Human Person Category 3 (RIPH3) - Non-Interventional (RNI) - Questionnaire (Jardé Law)
- Being tested
- Data collection, Questionnaires
- Keywords
- Pentamidine, Amphotericin B, Meglumine Antimoniate, oral administration, intraveinous administration, intramuscular administration, French Guiana
- Medical subject headings
- Leishmaniasis, Cutaneous, Treatment Adherence and Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data collectionOther
- Retrospective data collection in database from medical records (clinical, parasitological and therapeutic data)
QuestionnairesOther
- Administration of two standardized questionnaires by telephone in prospective:
- Dermatology Life Quality Index (DLQI)
- Treatment Satisfaction Questionnaire for Medication (TSQM)
| Study group | Role | What they receive |
|---|---|---|
| Patients | * Mucocutaneous Leishmaniasis proven by culture and/or polymerase chain reaction (PCR)
* Seen in French Guiana between 01/01/2017 and 01/04/2022, in dispensaries (CDPS) or in the Dermatology Department of the CHC
* Having received treatment with Miltefosine
* Patient who consented to participate in the study
* Age equal or superior to 18 years Receives: Other: Data collection; Other: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disappearance of any lesion without the appearance of a new lesion, 6 months from the start of treatment with miltefosine
The primary endpoint will be therapeutic success, defined as the disappearance of any lesion without the appearance of a new lesion, 6 months from the start of treatment with miltefosine.
Measured: baseline
Secondary outcomes (3)
Proportion of treatment-emergent adverse events occurring during treatment
Proportion of treatment-emergent adverse events occurring during treatment, categorized as follows: non-symptomatic laboratory abnormalities (mild); symptoms not leading to discontinuation or modification of treatment (moderate intensity); symptoms leading to discontinuation or dose reduction (severe intensity)
Measured: baseline
Patients' acceptability of treatment assessed after completion of treatment
Patients' acceptability of treatment assessed after completion of treatment, by Treatment Satisfaction Questionnaire for Medication (TSQM) administered by telephone
Measured: baseline
Impact of Cutaneous Leishmaniasis on quality of life
Impact of Cutaneous Leishmaniasis on quality of life, assessed retrospectively by Dermatology Life Quality Index (DLQI) questionnaire administered by telephone
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2022
- Study start8 Aug 2022 (estimated)
- Primary completion8 Aug 2022 (estimated)
- Study completion8 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier de Cayenne
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Romain BLAIZOT, Principal investigator, Centre Hospitalier de Cayenne, Dermatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05493059
- Sponsor's protocol ID
- 2022_028
- Acronym
- MILT2022
- Status last verified
- Aug 2022
- First submitted
- 5 Aug 2022
- Last updated
- 9 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Cases of Cutaneous Leishmaniasis Treated With Miltefosine in French Guiana, Retrospective Study Before Clinical Trial (MILT 2022)
- ClinicalTrials.gov ID
- NCT05493059
- Acronym / sponsor ID
- MILT2022 / 2022_028
- Keywords
- Pentamidine, Amphotericin B, Meglumine Antimoniate, oral administration, intraveinous administration, intramuscular administration, French Guiana
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Centre Hospitalier de CayenneUniversity, hospital or other
- Study start
- 8 Aug 2022 (estimated)
- Primary completion
- 8 Aug 2022 (estimated)
- Study completion
- 8 Oct 2022 (estimated)
- First posted
- 9 Aug 2022 (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.
Miltefosine is the only oral treatment currently available for Cutaneous Leishmaniasis.
Despite several reports of good efficiency in other countries of South America, miltefosine remains limited to a compassionate use in France. The objective of this study is to collect data regarding the efficacy, safety and acceptability of miltefosine in patients treated in French Guiana since 2017.
Detailed description
In French Guiana, Cutaneous Leishmaniasis is mostly caused by Leishmania guyanensis (80% of cases), followed by L. braziliensis (10%) and rarer species. L. guyanensis is usually treated with a single injection of pentamidine. However, pentamidine-resistant infections (10%) and all L. braziliensis are treated with either amphotericine B or meglumine antimoniate. These treatments can only be used during an hospitalization, which is the source of important indirect costs and discomforts for patients from the remote areas of French Guiana. Miltefosine is the only oral treatment available for Cutaneous Leishmaniasis. While it is widely used in South America (with good reported efficacy), the data available in France are scarce. This treatment, if available on a larger scale in France, would allow a treatment without hospitalization, which would be very suitable for French Guianese patients.
Our objective is to collect data on patients already treated with miltefosine in French Guiana (current indications being failure, side effect or impossible delivery of amphotericine B and meglumine antimoniate) in order to assess its efficacy, safety and acceptability. Patients treated with miltefosine at the Cayenne Hospital Center between 2017 and 2022 will be contacted by phone so as to answer questions regarding their quality of life during the infection and their satisfaction concerning miltefosine as a treatment. Data on their symptoms and general informations will be extracted from the medical files.
Primary objective: To assess the efficacy, tolerance and acceptability of Miltefosine among patients already treated with this drug as part of its AAC in French Guiana.
Observational, retrospective and prospective, monocentric study Research Involving Human Person Category 3 (RIPH3) - Non-Interventional (RNI) - Questionnaire (Jardé Law)
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Other: Data collection, Other: Questionnaires* Mucocutaneous Leishmaniasis proven by culture and/or polymerase chain reaction (PCR) * Seen in French Guiana between 01/01/2017 and 01/04/2022, in dispensaries (CDPS) or in the Dermatology Department of the CHC * Having received treatment with Miltefosine * Patient who consented to participate in the study * Age equal or superior to 18 years |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients presenting Mucocutaneous Leishmaniasis proven by culture and/or polymerase chain reaction (PCR) seen in French Guiana between 01/01/2017 and 01/04/2022, in dispensaries (CDPS) or in the Dermatology Department of the CHC and having received treatment with Miltefosine
Key inclusion criteria (5 listed)
- Mucocutaneous Leishmaniasis proven by culture and/or polymerase chain reaction (PCR)
- Seen in French Guiana between 01/01/2017 and 01/04/2022, in dispensaries (CDPS) or in the Dermatology Department of the CHC
- Having received treatment with Miltefosine
- Patient who consented to participate in the study
- Age equal or superior to 18 years
Key exclusion criteria (4 listed)
- Clinically suspected but not parasitologically proven leishmaniasis
- Refusal to participate
- Age < 18
- Patient under legal guardianship
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 |
|---|---|---|
| Data collectiono Retrospective data collection in database from medical records (clinical, parasitological and therapeutic data) | Other | Patients |
| Questionnaireso Administration of two standardized questionnaires by telephone in prospective: * Dermatology Life Quality Index (DLQI) * Treatment Satisfaction Questionnaire for Medication (TSQM) | Other | Patients |
Primary outcome
Disappearance of any lesion without the appearance of a new lesion, 6 months from the start of treatment with miltefosine
Time frame: baseline
The primary endpoint will be therapeutic success, defined as the disappearance of any lesion without the appearance of a new lesion, 6 months from the start of treatment with miltefosine.
3 secondary outcomes
Proportion of treatment-emergent adverse events occurring during treatment
Time frame: baseline
Patients' acceptability of treatment assessed after completion of treatment
Time frame: baseline
Impact of Cutaneous Leishmaniasis on quality of life
Time frame: baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2022.
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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.
Romain BLAIZOT principal investigator
Centre Hospitalier de Cayenne, Dermatology
Questions about this trial
What is this clinical trial studying?
An observational study of Cutaneous Leishmaniases and Treatment Adherence, run by Centre Hospitalier de Cayenne.
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 5 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 9 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Romain BLAIZOT (+594 594 39 53 59, romain.blaizot@ch-cayenne.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disappearance of any lesion without the appearance of a new lesion, 6 months from the start of treatment with miltefosine (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Aug 2022.