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

NCT ID: NCT06692985

Last Updated: 2024-11-20

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 270 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-04-01
• Study Completion Date: 2024-03-01

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.

Detailed Description

Leishmaniasis is a parasitosis common to humans and animals (anthropozoonosis), caused by flagellated protozoa called Leishmanias, transmitted by the infective bite of the blood-sucking female of a dipteran insect called sandfly. The parasite reservoirs are wild rodents, humans, dogs. Many species of leishmania can infect humans with a multiplicity of clinical pictures that include visceral, localized, diffuse cutaneous forms and mucocutaneous forms.

Cutaneous leishmaniasis (CL) is a neglected tropical disease whose transmission to humans is based on the bite of sandflies previously contaminated on mammalian reservoirs. Worldwide, more than 200,000 new cases are reported annually. While the Americas and the Near or Middle East are the most important areas, sub-Saharan Africa is also concerned. In a systematic review of the literature published in 2018, Sunyoto et al. identified 54 clinical and epidemiological studies on LC in sub-Saharan Africa. Publications were found in 13 of the 48 countries in sub-Saharan Africa. This review highlighted inconsistent case reporting, clear under-publication and data gaps regarding the exact incidence of CL and its transmission factors, particularly in West Africa.

Indeed, cutaneous leishmaniasis is widely described in East Africa, where many studies have been carried out in Ethiopia, Kenya and Sudan. The presence of Leishmania major and Leishmania aethiopica is well documented, and the dynamics of the infection and its risk factors are studied. In West Africa, on the other hand, the data are more fragmented. The disease is historically reported in the "Cutaneous Leishmaniasis Belt", a Sahelian strip of semi-arid zones extending from Senegal to Sudan. WHO nevertheless estimates that the real number of LC contaminations in the sub-region is 5 to 10 times higher than reported.

Thus, no cases were reported between 2015 and 2017 in the sub-region, which is not very credible in view of the dynamics of declarations during the previous or following years. Over the period 2004-2008, only 155 cases per year were reported, across the following countries: Ghana, Mali, Cameroon, Nigeria, Senegal, DRC and Ivory Coast. No data were available for neighbouring countries with similar ecological contexts, such as Niger, Benin, Guinea or Burkina Faso. The latter is probably the country reporting cases on the most regular basis, with between 500 and 1500 cases/year between 1995 and 2015. Nevertheless, no case was reported between 2007 and 2010, which seems difficult to explain scientifically and again testifies to a lack of diagnosis or reporting.

WHO establishes " country profiles " on the epidemiology of LC for each endemic country and designs regional programmes to control the disease. It should be noted that while East African countries such as Kenya or Ethiopia have a well-documented profile, no profile is available for West African countries. In addition, no regional programme has been set up for sub-Saharan Africa, unlike the Americas, South-East Asia, the Eastern Mediterranean or Europe regions. These absences show how neglected this public health problem is in the African region.

Ghana was considered non-endemic to CL until a major outbreak in 2002-2003. More than 2000 cases were then diagnosed, and this after an active screening, following an initial epidemic signal of only about fifteen cases. It is therefore possible that other epidemics, or even a sporadic presence, have remained undetected in some areas of the country. It should be noted that the region of the epidemic (Ho district, Volta region) was bordered by neighbouring Togo, and the testimonies collected in the affected communities suggested an imported pathology. Moreover, it should be noted that this epidemic area in Ghana was located in a forest region, therefore ou tside the LC Belt classically described and the semi-arid areas generally incriminated. This example illustrates the need to explore the epidemiology of LC in areas that are considered non-endemic by their climate.

In a later study carried out in 2015 in 15 villages affected by this epidemic, samples were taken to isolate strains belonging to the Leishmania enriettii complex from three crops. This rarely described species was not generally considered pathogenic to humans. This example illustrates the need for better species diagnosis in some areas where Leishmania major is considered to be the only species involved, although recent data do not support this statement with certainty. The diagnosis of cutaneous leishmaniasis in West Africa is too often based on a simple clinical diagnosis, sometimes supported by a parasitological smear. However, this does not allow the diagnosis of the offending Leishmania species. The lack of molecular biology in isolated areas or populations with limited resources prevents precise knowledge of the species involved.

As for the treatment, it is often inaccessible due to its price or the logistical constraints related to transport. Meglumine antimoniate is the first-line treatment in Senegal but rarely available, while metronidazole is used in Niger. However, its effectiveness has not been strongly demonstrated. In Mali, dermatologists use cryotherapy and thermotherapy, and more rarely meglumine antimoniate. Cyclin-based ointments are also used to treat bacterial superinfection.

Across the subregion, patients are frequently lost to follow-up, due to the high cost of transport for populations in rural areas, which are mainly at risk. The lack of follow-up consultations does not make it possible to reliably assess the proportion of patients who recover spontaneously, those requiring active treatment, the effectiveness of the various treatments offered as well as the possible sequelae (disfiguring scars, etc.) in the absence of active treatment. A prospective cohort with active patient follow-up would provide valuable data to assess whether or not new treatment options are needed.

Overall, it therefore seems relevant to map more precisely the incidence of LC in West Africa, to identify in molecular biology the Leishmania species responsible, to deepen knowledge on the vectors and reservoirs involved and to evaluate the effectiveness and usefulness of current therapeutic options.

Conditions

Cutaneous Leishmaniasis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Single group

Patient of any age with suspicious skin lesions

Clinical and epidemiological data

Intervention Type: OTHER

Collection of clinical and epidemiological data on day 0

Parasitological samples

Intervention Type: OTHER

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

Assessment of clinical course and response to treatment

Intervention Type: OTHER

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

DLQI questionnaire

Intervention Type: OTHER

DLQI questionnaire at M6

Interventions

Clinical and epidemiological data

Collection of clinical and epidemiological data on day 0

Intervention Type: OTHER

Parasitological samples

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

Intervention Type: OTHER

Assessment of clinical course and response to treatment

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

Intervention Type: OTHER

DLQI questionnaire

DLQI questionnaire at M6

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier de Cayenne

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Romain BLAIZOT, MCU-PH

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier de Cayenne (CHC)

Locations

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

Bamako, Mali, Mali

Faculté de médecine/Université André Salifou BP806 Zinder NIGER

Zinder, Niger, Niger

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

Lomé, Togo, Togo

Countries

Mali; Niger; Togo

References

Alvar J, Velez ID, Bern C, Herrero M, Desjeux P, Cano J, Jannin J, den Boer M; WHO Leishmaniasis Control Team. Leishmaniasis worldwide and global estimates of its incidence. PLoS One. 2012;7(5):e35671. doi: 10.1371/journal.pone.0035671. Epub 2012 May 31.

Reference Type: BACKGROUND

PMID: 22693548 (View on PubMed)

Sunyoto T, Verdonck K, El Safi S, Potet J, Picado A, Boelaert M. Uncharted territory of the epidemiological burden of cutaneous leishmaniasis in sub-Saharan Africa-A systematic review. PLoS Negl Trop Dis. 2018 Oct 25;12(10):e0006914. doi: 10.1371/journal.pntd.0006914. eCollection 2018 Oct.

Reference Type: BACKGROUND

PMID: 30359376 (View on PubMed)

Eshetu B, Mamo H. Cutaneous leishmaniasis in north-central Ethiopia: trend, clinical forms, geographic distribution, and determinants. Trop Med Health. 2020 Jun 3;48:39. doi: 10.1186/s41182-020-00231-w. eCollection 2020.

Reference Type: BACKGROUND

PMID: 32518497 (View on PubMed)

Tamiru HF, Mashalla YJ, Mohammed R, Tshweneagae GT. Cutaneous leishmaniasis a neglected tropical disease: community knowledge, attitude and practices in an endemic area, Northwest Ethiopia. BMC Infect Dis. 2019 Oct 16;19(1):855. doi: 10.1186/s12879-019-4506-1.

Reference Type: BACKGROUND

PMID: 31619180 (View on PubMed)

Pareyn M, Van den Bosch E, Girma N, van Houtte N, Van Dongen S, Van der Auwera G, Massebo F, Shibru S, Leirs H. Ecology and seasonality of sandflies and potential reservoirs of cutaneous leishmaniasis in Ochollo, a hotspot in southern Ethiopia. PLoS Negl Trop Dis. 2019 Aug 19;13(8):e0007667. doi: 10.1371/journal.pntd.0007667. eCollection 2019 Aug.

Reference Type: BACKGROUND

PMID: 31425506 (View on PubMed)

Boakye DA, Wilson M, Kweku M. A review of leishmaniasis in west Africa. Ghana Med J. 2005 Sep;39(3):94-7.

Reference Type: BACKGROUND

PMID: 17299551 (View on PubMed)

Kweku MA, Odoom S, Puplampu N, Desewu K, Nuako GK, Gyan B, Raczniak G, Kronmann KC, Koram K, Botero S, Boakye D, Akuffo H. An outbreak of suspected cutaneous leishmaniasis in Ghana: lessons learnt and preparation for future outbreaks. Glob Health Action. 2011;4. doi: 10.3402/gha.v4i0.5527. Epub 2011 Jul 13.

Reference Type: BACKGROUND

PMID: 21765823 (View on PubMed)

Kwakye-Nuako G, Mosore MT, Duplessis C, Bates MD, Puplampu N, Mensah-Attipoe I, Desewu K, Afegbe G, Asmah RH, Jamjoom MB, Ayeh-Kumi PF, Boakye DA, Bates PA. First isolation of a new species of Leishmania responsible for human cutaneous leishmaniasis in Ghana and classification in the Leishmania enriettii complex. Int J Parasitol. 2015 Sep;45(11):679-84. doi: 10.1016/j.ijpara.2015.05.001. Epub 2015 Jun 19.

Reference Type: BACKGROUND

PMID: 26099650 (View on PubMed)

Diadie S, Diatta BA, Ndiaye M, Seck NB, Diallo S, Niang SO, Dieng MT. Cutaneous leishmaniasis in Senegal: a series of 38 cases at the Aristide Le Dantec University Hospital in Dakar. Med Sante Trop. 2018 Feb 1;28(1):106-108. doi: 10.1684/mst.2017.0722.

Reference Type: BACKGROUND

PMID: 29226827 (View on PubMed)

Traore B, Oliveira F, Faye O, Dicko A, Coulibaly CA, Sissoko IM, Sibiry S, Sogoba N, Sangare MB, Coulibaly YI, Traore P, Traore SF, Anderson JM, Keita S, Valenzuela JG, Kamhawi S, Doumbia S. Correction: Prevalence of Cutaneous Leishmaniasis in Districts of High and Low Endemicity in Mali. PLoS Negl Trop Dis. 2017 Feb 15;11(2):e0005379. doi: 10.1371/journal.pntd.0005379. eCollection 2017 Feb.

Reference Type: BACKGROUND

PMID: 28199331 (View on PubMed)

Kone AK, Niare DS, Thera MA, Kayentao K, Djimde A, Delaunay P, Kouriba B, Giudice PD, Izri A, Marty P, Doumbo OK. Epidemiology of the outbreak, vectors and reservoirs of cutaneous leishmaniasis in Mali: A systematic review and meta-analysis. Asian Pac J Trop Med. 2016 Oct;9(10):985-990. doi: 10.1016/j.apjtm.2016.07.025. Epub 2016 Aug 20.

Reference Type: BACKGROUND

PMID: 27794393 (View on PubMed)

Oliveira F, Doumbia S, Anderson JM, Faye O, Diarra SS, Traore P, Cisse M, Camara G, Tall K, Coulibaly CA, Samake S, Sissoko I, Traore B, Diallo D, Keita S, Fairhurst RM, Valenzuela JG, Kamhawi S. Discrepant prevalence and incidence of Leishmania infection between two neighboring villages in Central Mali based on Leishmanin skin test surveys. PLoS Negl Trop Dis. 2009 Dec 15;3(12):e565. doi: 10.1371/journal.pntd.0000565.

Reference Type: BACKGROUND

PMID: 20016847 (View on PubMed)

Paz C, Samake S, Anderson JM, Faye O, Traore P, Tall K, Cisse M, Keita S, Valenzuela JG, Doumbia S. Leishmania major, the predominant Leishmania species responsible for cutaneous leishmaniasis in Mali. Am J Trop Med Hyg. 2013 Mar;88(3):583-5. doi: 10.4269/ajtmh.12-0434. Epub 2013 Jan 16.

Reference Type: BACKGROUND

PMID: 23324218 (View on PubMed)

Coulibaly CA, Traore B, Dicko A, Samake S, Sissoko I, Anderson JM, Valenzuela J, Traore SF, Faye O, Kamhawi S, Oliveira F, Doumbia S. Impact of insecticide-treated bednets and indoor residual spraying in controlling populations of Phlebotomus duboscqi, the vector of Leishmania major in Central Mali. Parasit Vectors. 2018 Jun 14;11(1):345. doi: 10.1186/s13071-018-2909-2.

Reference Type: BACKGROUND

PMID: 29898753 (View on PubMed)

Berdjane-Brouk Z, Kone AK, Djimde AA, Charrel RN, Ravel C, Delaunay P, del Giudice P, Diarra AZ, Doumbo S, Goita S, Thera MA, Depaquit J, Marty P, Doumbo OK, Izri A. First detection of Leishmania major DNA in Sergentomyia (Spelaeomyia) darlingi from cutaneous leishmaniasis foci in Mali. PLoS One. 2012;7(1):e28266. doi: 10.1371/journal.pone.0028266. Epub 2012 Jan 20.

Reference Type: BACKGROUND

PMID: 22276095 (View on PubMed)

Anderson JM, Samake S, Jaramillo-Gutierrez G, Sissoko I, Coulibaly CA, Traore B, Soucko C, Guindo B, Diarra D, Fay MP, Lawyer PG, Doumbia S, Valenzuela JG, Kamhawi S. Seasonality and prevalence of Leishmania major infection in Phlebotomus duboscqi Neveu-Lemaire from two neighboring villages in central Mali. PLoS Negl Trop Dis. 2011 May 10;5(5):e1139. doi: 10.1371/journal.pntd.0001139.

Reference Type: BACKGROUND

PMID: 21572984 (View on PubMed)

Related Links

https://books.google.com/books/about/Parasitoses_et_mycoses.html?id=Y_DQDwAAQBAJ

Chabasse D, Danis M, Guiguen C. Parasitoses et mycoses des régions tempérées et tropicales. Elsevier Masson. 78 p

https://compagnon.librairiemedicale.com/complement_ouvrage/harrison/

Richard M. Leishmanioses. In : HARRISIN Médecine interne. Arnette. Paris; 1995. 896-899 p

Other Identifiers

LEISHAFRICA

Identifier Type: -

Identifier Source: org_study_id