NCT05941546

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
878

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 4, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 12, 2023

Completed
5 days until next milestone

Study Start

First participant enrolled

July 17, 2023

Completed
27 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 13, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 13, 2023

Completed
Last Updated

April 8, 2026

Status Verified

April 1, 2026

Enrollment Period

27 days

First QC Date

July 4, 2023

Last Update Submit

April 2, 2026

Conditions

Keywords

tick-borne encephalitisTBEVserologyPCR

Outcome Measures

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.

    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.

    month 2

Interventions

anti-TBEV serologyDIAGNOSTIC_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

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • Patient's opposition.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Limoges University Hosiptal

Limoges, 87000, France

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Encephalitis, Tick-Borne

Condition Hierarchy (Ancestors)

Encephalitis, ArbovirusEncephalitis, ViralCentral Nervous System Viral DiseasesCentral Nervous System InfectionsInfectionsInfectious EncephalitisArbovirus InfectionsVector Borne DiseasesTick-Borne DiseasesVirus DiseasesRNA Virus InfectionsFlavivirus InfectionsFlaviviridae InfectionsEncephalitisBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeuroinflammatory Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 4, 2023

First Posted

July 12, 2023

Study Start

July 17, 2023

Primary Completion

August 13, 2023

Study Completion

August 13, 2023

Last Updated

April 8, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations