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Completed

NCT Number: NCT05941546

Tick-borne Encephalitis Virus Research in Limousin

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.

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Key information

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Patient's opposition.

Treatment and study plan

anti-TBEV serology

Diagnostic Test

we will measure by ELISA in microplates the anti-TBEV IgG as well as the anti-TBEV IgM on the sera + in TBEV IgG. We 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, we will perform PCR on CSF if serum positive and CSF available

Primary outcomes

  1. Detection of anti-TBEV antibodies in serum

    Time frame: month 1

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

Secondary outcomes

  1. Search for the presence of TBEV in the CSF in case of positive serology. Determine the risk factors associated with this infection.

    Time frame: month 2

    the detection of TBEV RNA will be carried out by real-time RT-PCR in the CSF of patients with positive anti-TBEV serology (if associated CSF available). The analysis will be qualitative in order to obtain a positive/negative response on the presence of virus RNA in the sample.

    In order to obtain information on the context of the infection, a questionnaire will be sent to TBEV-positive patients.

Sponsors and collaborators

Lead sponsor

University Hospital, Limoges

Other

Registry information

Acronym: VITAL

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jul 12, 2023
Registry last updated
Apr 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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