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临床试验/NCT05941546
NCT05941546招募中不适用

Tick-borne Encephalitis Virus Research in Limousin

University Hospital, Limoges1 个研究点 分布在 1 个国家目标入组 1,500 人开始时间: 2023年7月17日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
1,500
试验地点
1
主要终点
Detection of anti-TBEV antibodies in serum

研究概览

简要总结

Cases of encephalitis of varying severity have been described in recent years in eastern France involving tick-borne encephalitis virus (TBEV). The main objective is to demonstrate the presence of TBEV in Limousin, in patients with a positive Lyme serology, or a neurological picture compatible with TBEV.

详细描述

Cases of encephalitis of varying severity have been described in recent years in eastern France involving tick-borne encephalitis virus (TBEV). The epidemiological situation in France is poorly known with about 20 cases diagnosed per year, mainly in Alsace and Haute-Savoie. The infection can result in fever and an influenza-like picture, which can be complicated by encephalitis-like neurological disorders, or even death. TBEV is transmitted by the tick Ixodes ricinus, which also carries Borrelia burgdorferi, the agent of Lyme disease. Limousin is one of the French regions with the highest prevalence of Lyme disease. These ticks can harbor various pathogens, including TBEV. A case was described in 2007 in Bordeaux. More recently, a case was described in Haute-Loire. The investigators are therefore interested today in the emergence of this virus in Limousin following a possible progression through the Massif Central, potentially favored by numerous anti-Covid-19 control containments. The study begins with a computer extraction of patients with Lyme serology from our GLIMS laboratory software (with positive or negative results), a check for non-oppositions. Then the investigators will measure by ELISA in microplates the anti-TBEV IgG as well as the anti-TBEV IgM on the sera + in TBEV IgG. The investigators will then send a patient questionnaire with an information note to document the context of this TBEV seropositivity and to eliminate false-positivities (vaccination). Finally, the investigators will perform PCR on CSF if serum positive and CSF available, followed by an analysis of results.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Retrospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Patient with Lyme serology. Neurological picture compatible with neuroborreliosis or encephalitis.
  • No objection from the patient to the use of biobank samples

排除标准

  • Patient's opposition.

结局指标

主要结局

Detection of anti-TBEV antibodies in serum

时间窗: month 1

The primary endpoint is the detection of anti-TBEV antibodies in the serum of the study population.

次要结局

  • Search for the presence of TBEV in the CSF in case of positive serology. Determine the risk factors associated with this infection.(month 2)

研究者

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

研究点 (1)

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