Epidemiology of Cutaneous Leishmaniasis in Niger, Mali, Togo : Mapping of Clinical Cases, Species, Reservoirs and Vectors of the Disease

NCT06692985 | Completed

• 1 other identifier: LEISHAFRICA
• Study Type: observational
• Target: 270
• Locations: 3 countries
• Sites: 3

Brief Summary

Cutaneous leishmaniasis is a neglected tropical disease caused by parasites belonging to the genus Leishmania. This infection can cause skin and sometimes mucous membrane lesions with significant damage. LC has been little studied in sub-Saharan Africa where its incidence is probably underestimated, especially in West Africa. Leishmania major is almost the only isolated species in this region, although recent data suggest the existence of other species, such as L. enrietti. It is said that CL is only present in the arid areas of Africa, but recent outbreaks in wetlands and forests tend to contradict this theory. Due to the lack of availability of the PCR method, the diagnosis of LC in West Africa, especially in Mali, is rarely confirmed. Treatment options are also scarce and their effectiveness is poorly documented. The objectives of this study are to map the occurrence of LC cases with molecular biology confirmation in Niger, Mali and Togo; to determine the different species involved in human cases; evaluate the different treatment options available.

Conditions

Cutaneous Leishmaniasis

Keywords

Phylogeny; Sub-Saharian Africa; Mali; Togo; Niger; Sentinel surveillance; Therapeutic

Outcome Measures

Primary Outcomes (1)

• Presence of a positive test (smear or PCR) for Leishmaniasis Cutaneous (LC)

  Presence of a positive test (smear or PCR) for Leishmaniasis Cutaneous (LC) at Day 0

  Day 0

Secondary Outcomes (3)

• Leishmania species

  Day 0

• Number of participants with therapeutic failure or success

  Month 6

• Presence of scars with impact on quality of life

  Month 6

Study Arms (1)

Single group

Patient of any age with suspicious skin lesions

Other: Clinical and epidemiological data; Other: Parasitological samples; Other: Assessment of clinical course and response to treatment; Other: DLQI questionnaire

Interventions

Clinical and epidemiological data OTHER

Collection of clinical and epidemiological data on day 0

Single group

Parasitological samples OTHER

Parasitological samples : smear for on-site analysis and swabs to be sent to the Cayenne Hospital for PCR at day 0

Single group

Assessment of clinical course and response to treatment OTHER

Follow-up visit with assessment of clinical course and response to treatment at M6

Single group

DLQI questionnaire OTHER

DLQI questionnaire at M6

Single group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The human study population will consist of all subjects of all ages with suspicious skin lesions.

You may qualify if:

• Clinical suspicion of cutaneous leishmaniasis during a consultation in one of the partner centres (or by the country physicians) = presence of an ulcerative lesion, papules or nodules
• Obtaining informed and voluntary consent

You may not qualify if:

• Objection to the use of their data and/or the taking of the questionnaire
• Refusal to participate
• Withdrawal of participation

Sponsors & Collaborators

• Centre Hospitalier de Cayenne: lead

Study Sites (3)

Faculté de Médecine et d'Odonto-Stomatologie / Université des Sciences, des Techniques et des Technologies de Bamako, Mali

Bamako, Mali, BP 1805, Mali

Location

Faculté de médecine/Université André Salifou BP806 Zinder NIGER

Zinder, Niger, Niger

Location

Service de Dermatologie, CHR TSEVIE, Faculté des Sciences de la Santé, Université de Lomé

Lomé, Togo, Togo

Location

Related Publications (16)

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Related Links

• Chabasse D, Danis M, Guiguen C. Parasitoses et mycoses des régions tempérées et tropicales. Elsevier Masson. 78 p
• Richard M. Leishmanioses. In : HARRISIN Médecine interne. Arnette. Paris; 1995. 896-899 p

Biospecimen

Retention: SAMPLES WITHOUT DNA

Parasitological samples (smear and swabs for PCR)

MeSH Terms

Conditions

Leishmaniasis, Cutaneous

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

Study Officials

• Romain BLAIZOT, MCU-PH

  Centre Hospitalier de Cayenne (CHC)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 6, 2024
• First Posted: November 18, 2024
• Study Start: April 1, 2023
• Primary Completion: March 1, 2024
• Study Completion: March 1, 2024
• Last Updated: November 20, 2024

Record last verified: 2024-11

Locations

MA (1); TO (1); NI (1)