Clinical Trial Details
— Status: Not yet recruiting
Administrative data
NCT number |
NCT05493059 |
Other study ID # |
2022_028 |
Secondary ID |
|
Status |
Not yet recruiting |
Phase |
|
First received |
|
Last updated |
|
Start date |
August 8, 2022 |
Est. completion date |
October 8, 2022 |
Study information
Verified date |
August 2022 |
Source |
Centre Hospitalier de Cayenne |
Contact |
Romain BLAIZOT |
Phone |
+594 594 39 53 59 |
Email |
romain.blaizot[@]ch-cayenne.fr |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical 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. 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.
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)