Prevalence of Tick-borne Encephalitis in the Pediatric Population Treated at the HUS and Characterization of Confirmed Pediatric Cases (TBE-KID)

Prevalence of Tick-borne Encephalitis (TBE) in the Pediatric Population Treated at the University Hospitals of Strasbourg (HUS) and Characterization of Confirmed Pediatric Cases

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

Study Overview

• Status: Recruiting
• Conditions: Tick-borne Encephalitis

• Study Type: Observational
• Enrollment (Anticipated): 500

Contacts and Locations

• Study Contact: Name: Aurélie Velay-Rusch, MD; Phone Number: 33 3 69 55 14 40; Email: Aurelie.velay@chru-strasbourg.fr

Study Locations

• France
  • Strasbourg, France, 67091
    • Recruiting
    • Service Laboratoire de Virologie - PTM - CHU de Strasbourg - France
    • Contact: Aurélie Velay-Rusch, MD; Phone Number: 33 3 69 55 14 40; Email: Aurelie.velay@chru-strasbourg.fr
    • Principal Investigator: Aurélie Velay-Rusch, MD
    • Sub-Investigator: Assilina Parfut, PharmD
    • Sub-Investigator: Marie-Josée Wendling, MD
    • Sub-Investigator: Samira Fafi-Kremer, PharmD
    • Sub-Investigator: Ludovic Glady, MD
    • Sub-Investigator: Baer Baer, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 14 years (Child)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-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.

Description

Inclusion criteria:

• 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.

Exclusion criteria:

• 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, ...)

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Determining the prevalence of TBE in pediatric patients (aged 0 to 15 years)	2 years after infection with tick-borne encephalitis (TBE)

Collaborators and Investigators

• Sponsor: University Hospital, Strasbourg, France

Study record dates

Study Major Dates

• Study Start (Actual): October 24, 2022
• Primary Completion (Anticipated): August 24, 2023
• Study Completion (Anticipated): October 24, 2023

Study Registration Dates

• First Submitted: October 31, 2022
• First Submitted That Met QC Criteria: October 31, 2022
• First Posted (Actual): November 7, 2022

Study Record Updates

• Last Update Posted (Actual): November 14, 2022
• Last Update Submitted That Met QC Criteria: November 7, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: Tick-borne encephalitis (TBE); Genus Ixodes; TBEV infection; TBEV infection in children; Prevalence of TBE
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; RNA Virus Infections; Virus Diseases; Infections; Encephalitis, Arbovirus; Encephalitis, Viral; Central Nervous System Viral Diseases; Central Nervous System Infections; Infectious Encephalitis; Arbovirus Infections; Vector Borne Diseases; Flavivirus Infections; Flaviviridae Infections; Tick-Borne Diseases; Encephalitis; Encephalitis, Tick-Borne
• Other Study ID Numbers: 8725

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No