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临床试验/NCT05300425
NCT05300425已完成不适用

Leptospirosis, Tularaemia and Hepatitis E in a Rural Mountain Valley in the Alpine Region of Switzerland - A Cross-sectional Exploratory Seroprevalence Study

University Hospital, Basel, Switzerland2 个研究点 分布在 1 个国家目标入组 258 人开始时间: 2022年3月3日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
258
试验地点
2
主要终点
Change in presence of antibodies against Leptospira spp, Francisella tularensis and Hepatitis E

研究概览

简要总结

Human leptospirosis is a zoonotic disease caused by bacteria of the genus Leptospira. Due to its frequent inapparent course or mild severity with unspecific symptoms and limited availability of diagnostic laboratories the incidence of leptospirosis is likely to be underestimated. The hospital of Val Müstair is the major healthcare provider of a rural mountain valley in the canton of Graubünden/ Switzerland with approximately 1500 inhabitants. A relevant prevalence of Leptospira spp. antibodies in the population of the Val Müstair due to its geographic and social risk profile for Leptospira infection, namely the close contact of the population to both livestock and wildlife in agriculture and hunting is estimated. The aim of this study is to analyze the burden of this disease in order to evaluate the need of preventive measures. In addition, seroepidemiological data for the Hepatitis E virus (HEV) and for tularemia will be collected.

研究设计

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

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Informed consent as documented by signature
  • Aged 18 years or older
  • Living for at least one year mainly (>6 months per year) in Val Müstair (including Taufers and Rifair, Italy)

排除标准

  • Inability to give consent
  • Inability to follow procedures
  • Acute infections/inflammatory disease

结局指标

主要结局

Change in presence of antibodies against Leptospira spp, Francisella tularensis and Hepatitis E

时间窗: at baseline and approximately two years after baseline (project duration for each patient is one day or two days respectively, if they agree for another blood sampling in two years)

Change in presence of antibodies against Leptospira spp, Francisella tularensis and Hepatitis E evaluated by serology at two different time points

次要结局

  • Change in presence of antibodies in risk populations (hunters and farmers)(at baseline and approximately two years after baseline (project duration for each patient is one day or two days respectively, if they agree for another blood sampling in two years))

研究者

发起方
University Hospital, Basel, Switzerland
申办方类型
Other
责任方
Sponsor

研究点 (2)

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