跳至主要内容
临床试验/NCT05031091
NCT05031091Unknown不适用

Epidemiology of Leprosy in French Guiana

Centre Hospitalier de Cayenne1 个研究点 分布在 1 个国家目标入组 368 人开始时间: 2020年1月7日最近更新:
适应症

试验速览

阶段
不适用
入组人数
368
试验地点
1
主要终点
Genotype of M. Leprae srtrains

研究概览

简要总结

The main objective of the present study is the genotyping of M. leprae strains found in leprosy patients in French Guiana. The secondary objectives are to investigate the presence of M. lepromatosis in these patients, the molecular research of M. leprae resistance to anti-leprosy antibiotics, the study of risk factors for leprosy in humans in Guyana and in particular direct or indirect contact with armadillos, as well as the determination of phylogenetic links between the M. leprae strains found in French Guiana, and with the regional and world reference strains Epidemiology of leprosy in French Guiana.

详细描述

Rationale: Leprosy (also known as Hansen's disease) is a chronic infection caused by intracellular mycobacteria, Mycobacterium leprae and Mycobacterium lepromatosis (discovered in 2008), preferentially affecting the skin and peripheral nervous system. The disease in humans is potentially disabling and stigmatising.

The modes of transmission of leprosy are not yet fully understood, although it is generally accepted that the main mode of transmission is human-to-human. Apart from humans, the only other major confirmed animal reservoir of M. leprae is the 9-banded armadillo Dasypus novemcinctus, which is found only in the Americas. Recent studies in the southern United States suggest transmission of M. leprae between D. novemcinctus and humans, where 64% of human cases may be attributable to armadillos. Uncertainties remain regarding the zoonotic nature of the disease outside the US and the precise mode of transmission.

The disease is endemic on the American continent where 92% of new cases come from Brazil. In French Guiana - bordering Brazil - leprosy is still present and shows a tendency to recrudesce with about 10 new cases per year. Armadillo consumption is frequent.

Objectives: The main objective of the present study is the genotyping of M. leprae strains found in leprosy patients in French Guiana. The secondary objectives are to investigate the presence of M. lepromatosis in these patients, the molecular research of M. leprae resistance to anti-leprosy antibiotics, the study of risk factors for leprosy in humans in Guyana and in particular direct or indirect contact with armadillos, as well as the determination of phylogenetic links between the M. leprae strains found in French Guiana, and with the regional and world reference strains Population and methods: A cross-sectional study will be conducted on approximately 150 cases of leprosy diagnosed between 2006 and 2022 in French Guyana, seen by the department's anti-leprosy service and for which a skin biopsy (or dermal smear or nasal swab) is available. Genotyping of M. leprae and the search for antibiotic resistance, as well as the search for M. lepromatosis will be carried out by molecular biology. Human strains will be compared with environmental strains from French Guiana and with reference strains found in humans and armadillos. A minimum-spanning-tree and maximum parsimony analysis will be performed to determine the phylogenetic relationships between the different strains.

A 3:1 matched case-control study will be conducted to assess risk factors for leprosy in French Guiana. The 92 cases will be recruited from among leprosy cases diagnosed between 2006 and 2022 in French Guyana, seen by the departmental leprosy control. The 276 controls will be recruited by dermatologists from the Cayenne hospital, throughout the territory, by matching 3 controls per case according to sex and age (± 5 years). A standardised exposure questionnaire will be conducted face to face or by telephone. The search for leprosy risk factors and in particular direct or indirect contact with armadillos (proximity / hunting / handling / consumption) will be explored by univariate and then multivariate conditional logistic regressions taking into account known potential confounding factors.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Other

入排标准

性别
All
接受健康志愿者

入选标准

  • FOR TRANSVERSAL STUDY:
  • any patient, regardless of age, consulting a practitioner at the Cayenne Hospital with a clinical suspicion of leprosy
  • Diagnosis of leprosy, confirmed histologically or bacteriologically, made in Guyana between 2006 and 2022
  • Skin biopsy (or dermal smear or nasal swab) available in the anatomopathology department of the Andrée Rosemon Hospital and analysable (correct state of preservation and sufficient quantity of tissue)
  • FOR CASE-CONTROL STUDY - CASES:
  • any patient, regardless of age, consulting a practitioner at the Cayenne Hospital with a clinical suspicion of leprosy
  • Diagnosis of leprosy, confirmed histologically or bacteriologically, made in Guyana between 2006 and 2022
  • FOR CASE-CONTROL STUDY - CONTROL:
  • Any patient, of any age, consulting for a dermatological pathology not clinically suspicious of leprosy during a dermatological consultation by a practitioner of the Cayenne Hospital

排除标准

  • FOR TRANSVERSAL STUDY:
  • Opposition to participation
  • Diagnosis of leprosy invalidated after inclusion
  • FOR CASE-CONTROL STUDY - CASES:
  • Opposition to participation
  • Inability to answer to the questionnaire
  • Diagnosis of leprosy invalidated after inclusion
  • FOR CASE-CONTROL STUDY - CONTROL:
  • Opposition to participation
  • Inability to answer to the questionnaire

结局指标

主要结局

Genotype of M. Leprae srtrains

时间窗: 1 day

Genotyping of M. leprae strains will be genotyped by determining the type (1,2,3,4), subtype (A, B, C, D, E, F, G, H, I, J, K, L, M, N, O, P) by SNP (Single Nucleotide Polymorphism) sequencing and VNTR (Variable Number Tandem Repeat) typing of each selected strain, as recommended by Singh and Cole and used by Truman and Sharma , or, depending on the bacterial index and technical possibilities, by whole genome sequencing, as described by Stefani.

次要结局

  • Phylogenetic relationships between strains(1 day)
  • M. lepromatosis positivity determined by qPCR (real-time PCR)(1 day)
  • identification of indirect contact (proximity/work on the land) with armadillos and other wild animals(1 day)
  • presence of antibiotic resistance mutation(1 day)
  • identification of direct contact (hunting/handling/consumption) with armadillos and other wild animals(1 day)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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