Primary Health Care Clinical Trial
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.
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) ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03224858 -
Ambulatory ICU Study for Medically and Socially Complex Patients
|
N/A | |
| Completed |
NCT03663075 -
Effect of Group Education and Individual Counselling on Mental Health and Quality of Life in 45-60 Year Old Women
|
N/A | |
| Recruiting |
NCT04151056 -
Impact of the Social Determinants of Health in the Central Catalan Region
|
||
| Recruiting |
NCT05715151 -
Continuous Quality Improvement Cohorts on Advanced Access
|
N/A | |
| Completed |
NCT01242319 -
Translating ATP III Cholesterol Management Guidelines Into Primary Care Practice
|
N/A | |
| Recruiting |
NCT06155292 -
Report Cards and Feedback for PCCE
|
N/A | |
| Completed |
NCT02955433 -
The Impact of Rideshare Transportation Services on Appointment Adherence
|
N/A | |
| Completed |
NCT02266069 -
PROject - Supportive and Palliative Care and INnOvation - Antwerp (Pro-Spinoza)
|
N/A | |
| Recruiting |
NCT04702711 -
Experiences of Anger in Patients in Primary Health Care With Symptoms of Generalized Anxiety
|
||
| Completed |
NCT04521816 -
PIM 2.0: Patient Aligned Care Team (PACT) Intensive Management (PIM) Project
|
N/A | |
| Recruiting |
NCT05709860 -
An Electronic Health Record-based Approach to Increase PrEP Knowledge and Uptake: the EMC2 PrEP Strategy
|
N/A | |
| Completed |
NCT05121688 -
Effectiveness of a Physical Therapy Telerehabilitation Program in Long Post COVID-19 Symptoms in Primary Health Care.
|
N/A | |
| Completed |
NCT05329246 -
Validation of PMcardio AI-assisted Clinical Assistant in Primary Care
|
N/A | |
| Completed |
NCT02953925 -
National-wide Survey on Primary Health Care in China
|
N/A | |
| Completed |
NCT03100526 -
Patient Aligned Care Team (PACT) Intensive Management (PIM) Project
|
N/A | |
| Active, not recruiting |
NCT04585191 -
Reducing Treatment Risk in Older Adults With Diabetes
|
N/A | |
| Recruiting |
NCT05609981 -
Optimising Medication With Focus on Deprescribing in Frail Older People With Multidose Drug Dispensing Systems
|
N/A | |
| Completed |
NCT04688359 -
Effectiveness of Nurse-coordinated Follow-up Program in Primary Care for People at Risk for T2DM
|
N/A | |
| Withdrawn |
NCT04010136 -
Identification of Elderly Patients in Need of Palliative Care by Family Physicians
|
N/A | |
| Completed |
NCT04237883 -
Primary Care Clinical Excellence Incentive Study
|
N/A |