Clinical trial NCT05941546: Tick-borne Encephalitis Virus Research in Limousin
Official title: Tick-borne Encephalitis Virus Research in Limousin
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Tick-borne Encephalitis
Keywords: tick-borne encephalitis
TBEV
serology
PCR
Lead sponsor: University Hospital, Limoges
Sponsor class: OTHER
First posted: 2023-07-12
Enrollment: 878
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with Lyme serology from our GLIMS laboratory software (with positive or negative results)

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Detection of anti-TBEV antibodies in serum
timeFrame: month 1
Secondary outcomes:
measure: Search for the presence of TBEV in the CSF in case of positive serology. Determine the risk factors associated with this infection.
timeFrame: month 2
Other outcomes:
Locations:
city: Limoges
country: France
facility: Limoges University Hosiptal
Study officials:
References: