VITAL: Tick-borne Encephalitis Virus Research in Limousin

Sponsor
University Hospital, Limoges (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05941546
Collaborator
(none)
1,500
1
8
187.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: anti-TBEV serology

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 (Velay A. et al., 2017). 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 (Santé publique France). These ticks can harbor various pathogens, including TBEV. A case was described in 2007 in Bordeaux (Herpe B. et al., 2007). More recently, a case was described in Haute-Loire (Botelho-Nevers E , EID, 2019). We 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 (Borșan et al. Parasites Vectors, 2021). 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 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, followed by an analysis of results.

Study Design

Study Type:
Observational
Anticipated Enrollment :
1500 participants
Observational Model:
Case-Only
Time Perspective:
Retrospective
Official Title:
Tick-borne Encephalitis Virus Research in Limousin
Anticipated Study Start Date :
Jul 1, 2023
Anticipated Primary Completion Date :
Sep 1, 2023
Anticipated Study Completion Date :
Mar 1, 2024

Outcome Measures

Primary Outcome Measures

  1. Detection of anti-TBEV antibodies in serum [month 1]

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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Limoges University Hosiptal Limoges France 87000

Sponsors and Collaborators

  • University Hospital, Limoges

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Hospital, Limoges
ClinicalTrials.gov Identifier:
NCT05941546
Other Study ID Numbers:
  • 87RI23_0012
First Posted:
Jul 12, 2023
Last Update Posted:
Jul 12, 2023
Last Verified:
Jul 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University Hospital, Limoges
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 12, 2023