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临床试验/NCT06692985
NCT06692985已完成不适用

Sentinel Surveillance of Cutaneous Leishmaniasis in Sub-Saharan Africa Based on Non-invasive Molecular Diagnostics: Mapping of Human Cases, Description of Leishamania Species Involved

Centre Hospitalier de Cayenne3 个研究点 分布在 3 个国家目标入组 270 人开始时间: 2023年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
270
试验地点
3
主要终点
Presence of a positive test (smear or PCR) for Leishmaniasis Cutaneous (LC)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • 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
  • Non inclusion /

排除标准

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

结局指标

主要结局

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

时间窗: Day 0

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

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (3)

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