Tick-borne EncephalitisTBE-KIDNCT05607394
Prevalence of Tick-borne Encephalitis in the Pediatric Population Treated at the HUS and Characterization of Confirmed Pediatric Cases
An observational study of Tick-borne Encephalitis, run by University Hospital, Strasbourg, France at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 0 to 16 years
- Conditions the study is for
- Tick-borne Encephalitis
- How many people
- 500 participants
- Where
- 1 siteFrance
- Study dates
- 24 Oct 2022to 24 Oct 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 16 years
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- 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.
Who cannot join
- 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, ...)
Trial locations and contacts
1 site in 1 country.
France1 site
Service Laboratoire de Virologie - PTM - CHU de Strasbourg - France
Strasbourg, Strasbourg, 67091
About this study
Official title: 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
- Conditions
- Tick-borne Encephalitis
- Keywords
- Tick-borne encephalitis (TBE), Genus Ixodes, TBEV infection, TBEV infection in children, Prevalence of TBE
- Medical subject headings
- Encephalitis, Tick-Borne
What is being measured
The primary outcome is the main question the study is designed to answer.
Determining the prevalence of TBE in pediatric patients (aged 0 to 15 years)
Measured: 2 years after infection with tick-borne encephalitis (TBE)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2022
- Study start24 Oct 2022
- Primary completion24 Aug 2023
- Study completion24 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tick-borne EncephalitisStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05607394
- Sponsor's protocol ID
- 8725
- Acronym
- TBE-KID
- Status last verified
- Oct 2026
- First submitted
- 31 Oct 2022
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Tick-borne Encephalitis (TBE) in the Pediatric Population Treated at the University Hospitals of Strasbourg (HUS) and Characterization of Confirmed Pediatric Cases
- ClinicalTrials.gov ID
- NCT05607394
- Acronym / sponsor ID
- TBE-KID / 8725
- Conditions
- Tick-borne Encephalitis
- Keywords
- Tick-borne encephalitis (TBE), Genus Ixodes, TBEV infection, TBEV infection in children, Prevalence of TBE
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 24 Oct 2022 (actual)
- Primary completion
- 24 Aug 2023 (actual)
- Study completion
- 24 Oct 2023 (actual)
- First posted
- 7 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 0 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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, ...)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Determining the prevalence of TBE in pediatric patients (aged 0 to 15 years)
Time frame: 2 years after infection with tick-borne encephalitis (TBE)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tick-borne Encephalitis, run by University Hospital, Strasbourg, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determining the prevalence of TBE in pediatric patients (aged 0 to 15 years) (time frame: 2 years after infection with tick-borne encephalitis (TBE)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2026; AzTrials last refreshed its copy on 8 Nov 2026.