Study of Cases of Cutaneous Leishmaniasis Treated With Miltefosine in French Guiana, Retrospective Study

NCT05493059 | Unknown

• 1 other identifier: 2022_028
• Study Type: observational
• Target: 20
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cutaneous Leishmaniases; Treatment Adherence; Primary Health Care; Drug Evaluation

Keywords

Pentamidine; Amphotericin B; Meglumine Antimoniate; oral administration; intraveinous administration; intramuscular administration; French Guiana

Outcome Measures

Primary Outcomes (1)

• 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.

  baseline

Secondary Outcomes (3)

• Proportion of treatment-emergent adverse events occurring during treatment

  baseline

• Patients' acceptability of treatment assessed after completion of treatment

  baseline

• Impact of Cutaneous Leishmaniasis on quality of life

  baseline

Study Arms (1)

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

Other: Data collection; Other: Questionnaires

Interventions

Data collection OTHER

o Retrospective data collection in database from medical records (clinical, parasitological and therapeutic data)

Patients

Questionnaires OTHER

o Administration of two standardized questionnaires by telephone in prospective: * Dermatology Life Quality Index (DLQI) * Treatment Satisfaction Questionnaire for Medication (TSQM)

Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Centre Hospitalier de Cayenne: lead

MeSH Terms

Conditions

Leishmaniasis, Cutaneous; Treatment Adherence and Compliance

Interventions

Data Collection; Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Leishmaniasis; Euglenozoa Infections; Protozoan Infections; Parasitic Diseases; Infections; Skin Diseases, Parasitic; Vector Borne Diseases; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Romain BLAIZOT

  Centre Hospitalier de Cayenne, Dermatology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Romain BLAIZOT

CONTACT

+594 594 39 53 59; romain.blaizot@ch-cayenne.fr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2022
• First Posted: August 9, 2022
• Study Start: August 8, 2022
• Primary Completion: August 8, 2022
• Study Completion: October 8, 2022
• Last Updated: August 9, 2022

Record last verified: 2022-08