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CompletedNCT05941546VITALUpdated Apr 8, 2026

Tick-borne Encephalitis Virus Research in Limousin

An observational study in Tick-borne Encephalitis, sponsored by University Hospital, Limoges. Completed at 1 site in France. Per ClinicalTrials.gov, last updated 2026-04-08.

Sponsored by University Hospital, Limoges · Observational

Study type
Observational
Model
Case-only
Time perspective
Retrospective
Enrollment
878
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Tick-borne Encephalitis

Keywords

  • tick-borne encephalitis
  • TBEV
  • serology
  • PCR
03

In context

Encephalitis, Tick-Borne

51 studies on the registry are indexed under Encephalitis, Tick-Borne; 9 are open to participants now.

This study's enrollment of 878 is above the median of 500 across 11 observational studies indexed under Encephalitis, Tick-Borne.

Browse Encephalitis, Tick-Borne studies →

Lead sponsor

University Hospital, Limoges is the lead sponsor of 264 studies on the registry; 38 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Sampling method
Non-probability sample

Study population

patients with Lyme serology from our GLIMS laboratory software (with positive or negative results)

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Patient's opposition.
05

Study design

Observational model
Case-only
Time perspective
Retrospective
Enrollment
878 participants (actual)
Patient registry
No

Interventions

  • Diagnostic testanti-TBEV serology

    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

06

What researchers measure

Primary outcomes

  1. Detection of anti-TBEV antibodies in serum

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

    Time frame: month 1

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.

    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.

    Time frame: month 2

07

Study locations

1 site
  • Limoges University Hosiptal
    Limoges, 87000, France
08

References and documents

Publications

  • Bisserier E, Perraud A, Ayhan N, Durand GA, de Lamballerie X, Hantz S. Serological evidence of tick-borne encephalitis virus in limousin, france. Int J Infect Dis. 2026 Apr;165:108424. doi: 10.1016/j.ijid.2026.108424. Epub 2026 Jan 27. PubMed 41610944 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jul 2023 to primary completion in Aug 2023, 0 months.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 4, 2023
First posted
Jul 12, 2023
StartActual
Jul 17, 2023
Primary completionActual
Aug 13, 2023
CompletionActual
Aug 13, 2023
Last update
Apr 8, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 8, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05941546
Responsible party
Sponsor
First posted
Jul 12, 2023
Start date
Jul 17, 2023
Primary completion
Aug 13, 2023
Completion
Aug 13, 2023
Last update
Apr 8, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

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