Clinical trial NCT05493059: Study of Cases of Cutaneous Leishmaniasis Treated With Miltefosine in French Guiana, Retrospective Study
Official title: Study of Cases of Cutaneous Leishmaniasis Treated With Miltefosine in French Guiana, Retrospective Study Before Clinical Trial (MILT 2022)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cutaneous Leishmaniases
Treatment Adherence
Primary Health Care
Drug Evaluation
Keywords: Pentamidine
Amphotericin B
Meglumine Antimoniate
oral administration
intraveinous administration
intramuscular administration
French Guiana
Lead sponsor: Centre Hospitalier de Cayenne
Sponsor class: OTHER
First posted: 2022-08-09
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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

Brief 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. 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)

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Clinically suspected but not parasitologically proven leishmaniasis
* Refusal to participate
* Age \< 18
* Patient under legal guardianship

Primary outcomes:
measure: Disappearance of any lesion without the appearance of a new lesion, 6 months from the start of treatment with miltefosine
timeFrame: baseline
Secondary outcomes:
measure: Proportion of treatment-emergent adverse events occurring during treatment
timeFrame: baseline
measure: Patients' acceptability of treatment assessed after completion of treatment
timeFrame: baseline
measure: Impact of Cutaneous Leishmaniasis on quality of life
timeFrame: baseline
Other outcomes:
Locations:
Study officials:
affiliation: Centre Hospitalier de Cayenne, Dermatology
name: Romain BLAIZOT
role: PRINCIPAL_INVESTIGATOR
References: