NCT05607394

Brief Summary

Tick-borne encephalitis (TBE) is a zoonosis mainly transmitted to humans by the bite of ticks of the genus Ixodes and, to a lesser extent, by the consumption of contaminated and unpasteurized dairy products. During the last decade, the epidemiology of this arbovirosis has changed profoundly with the discovery of new human cases and/or new areas of circulation of tick-borne encephalitis virus (TBEV) throughout Europe and particularly in France. Historically, Alsace is the main endemic area for this pathology in France. The pathology is notifiable since June 2021 in France. Although TBEV infection in children seems to lead to a milder clinical presentation, data are much less abundant than in adults and only a few cases reported in infants under 1 year old have been published. Data from the most recent ECDC Annual Epidemiological Report on TBE (2019) showed incidence rates of approximately 0.2 and 0.5 per 100,000 population in patients younger than 5 and 15 years, respectively. However, several observations may moderate and challenge both the low incidence rate and the less severe clinical presentation reported in children

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

October 24, 2022

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

October 31, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 7, 2022

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 24, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 24, 2023

Completed
Last Updated

November 14, 2022

Status Verified

October 1, 2022

Enrollment Period

10 months

First QC Date

October 31, 2022

Last Update Submit

November 7, 2022

Conditions

Keywords

Tick-borne encephalitis (TBE)Genus IxodesTBEV infectionTBEV infection in childrenPrevalence of TBE

Outcome Measures

Primary Outcomes (1)

  • Determining the prevalence of TBE in pediatric patients (aged 0 to 15 years)

    2 years after infection with tick-borne encephalitis (TBE)

Eligibility Criteria

Age0 Years - 16 Years
Sexall
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Minor subject (≤ 16 years) having had a CSF sample taken as part of care, without infectious (other than TBE) or non-infectious etiology diagnosed.

You may qualify if:

  • Minor subject (≤ 16 years)
  • hospitalized at the University Hospital of Strasbourg between 01/01/2020 and 31/12/2022
  • having had a CSF sample taken as part of care, without infectious (other than TBE) or non-infectious etiology diagnosed
  • whose parental authority holders have already given their consent for their child's biological resources to be kept in the "Microbiology" biocollection and reused for scientific research purposes.

You may not qualify if:

  • Patient or parental authority holders who have expressed their opposition to participate in the study
  • Any person, male or female, over 16 years of age,
  • or any person, male or female, under 16 years of age, treated at the University Hospitals of Strasbourg from January 2020 to December 2022, who has had a CSF sample taken as part of their care, for which a non-infectious etiology or an infectious etiology other than TBE has been diagnosed.
  • Impossible to give the subject informed information (difficulties in understanding the subject, ...)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service Laboratoire de Virologie - PTM - CHU de Strasbourg - France

Strasbourg, 67091, France

RECRUITING

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

Central Study Contacts

Study Design

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

Study Record Dates

First Submitted

October 31, 2022

First Posted

November 7, 2022

Study Start

October 24, 2022

Primary Completion

August 24, 2023

Study Completion

October 24, 2023

Last Updated

November 14, 2022

Record last verified: 2022-10

Locations