B. Burgdorferi InfectionBOBUINCANCT05856812
BOrrelia BUrgdorferi IN Children and Adolescents
An observational study of B. Burgdorferi Infection, run by University Children's Hospital Basel at 1 site in Switzerland.
Trial summary
The aim of this study is to assess B. burgdorferi antibodies in children and adolescents in north-western Switzerland and neighbouring countries ("Triregio") treated at the University Children's Hospital Basel to define age-dependent B. burgdorferi seroprevalence rates. Read more about this study
- Who is it for?
- Ages 1 year to 17 years
- Conditions the study is for
- B. Burgdorferi Infection
- How many people
- 962 participants
- Where
- 1 siteSwitzerland
- Study dates
- 23 Jun 2023to 6 Feb 2024
- 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 1 year to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: The study population will include children and adolescents, who presented at the University Childrens Hospital Basel in outpatient or inpatient setting. All children and adolescents, from whom a sufficient left over amount of the EDTA sample taken for clinical routine tests at the hematology laboratory of the University Childrens Hospital Basel will be included
Who may be able to join
- signed informed general consent
- residence in cantons Basel city, Basel country, Aargau, Solothurn and neighboring areas of France and Germany (Germany postal codes 794x, 795x, 796x, 797x and France postal codes 68480, 68640, 68220, 68330, 68300, 68128, 68730, 68870, 68510, 68130, 68640, 68960, 56890, 68118, 68580, 68680, 68440, 68720)
Who cannot join
- case blood is taken repetitively from the same child, only the first sample will be used and the child will only be included in the study once.
- Refugees seeking asylum will be excluded. These children will be identified by postal address of the Bundesasylzentrum.
- Children presenting for a diagnosis related to a B. burgdorferi infection will be excluded since including these children would result in an over-estimation of the pre-test prevalence of B. burgdorferi IgG due to a possible selection bias. Diagnosis related to a B. burgdorferi infection will include erythema migrans, borrelial lymphocytoma, early or late neuroborreliosis, acute arthritis or carditis, acrodermatitis chronica atrophicans.
- Children with underlying chronic disease, that potentially affects plasma antibodies will be excluded, these include for example the following conditions:
- known inborn or acquired immunodeficiency syndrome
- Systemic lupus erythematosus
Show all 10Show fewer
- Children with history of intravenous immunoglobulin treatment in the past 12 months for any reason including Kawasaki Disease, Paediatric Inflammatory Multisystem Syndrome, Immunothrombocytopenia.
- Children after allogenic stem cell transplantation.
- Children with cancer or known chronic hematology disease.
- Children treated with immunosuppressive treatment in the last 6 months including systemic steroids >2 weeks duration (>2mg/kg or >20 mg prednisone equivalent) or immunosuppressive combination treatments (e.g. biological disease modifying antirheumatic drugs (DMARDs) + conventional DMARDs), Rituximab or leflunomide
Trial locations and contacts
1 site in 1 country.
About this study
Official title: BOrrelia BUrgdorferi IN Children and Adolescents- a Seroprevalence Study
The aim of this study is to assess B. burgdorferi antibodies in children and adolescents in north-western Switzerland and neighbouring countries ("Triregio") treated at the University Children's Hospital Basel to define age-dependent B. burgdorferi seroprevalence rates.
Read the detailed description
Lyme borreliosis is one of the most prevalent tick-borne zoonosis in the northern hemisphere. Children with Borrelia (B.) burgdorferi infection present with different clinical stages and related symptoms: an early localized stage is commonly associated with an erythema migrans or a borrelial lymphocytoma. Early disseminated disease include early neuroborreliosis, acute arthritis or carditis. Later disease stages include acrodermatitis chronica atrophicans, late neuroborreliosis or Lyme Arthritis. B. burgdorferi prevalence is highest in Europe and has been increasing in the last decade.
Only limited data about the seroprevalence in children is available. A recently published systematic review and meta-analysis estimated the overall global seroprevalence at 14.5% (95% confidence interval (CI) 12.8-16.3%), and at 7.1% (95% CI 5.1-9.5%) in those <40 years of age (based on 18 studies). Only a few studies included in this systematic review assessed paediatric cohorts in Europe: One study from Germany was published 10 years ago and estimated the seroprevalence at 4.5% (95% CI 4.3-5.4%) in the age group 1-17 years. The seroprevalence was higher in males and in the southern part of Germany, and it increased by 11% and 6% for every year of age in boys and girls, respectively. A study from Sweden looked at 5-year old children and estimated a seroprevalence of 3.2%. More data about the seroprevalence is available in adults with heterogenous findings: recent studies from southern Germany, eastern Slovakia, Jordan, Finland and Romania, reported seroprevalence values of 2.4%, 13%, 11.7%, 3.9% and 7.4% respectively.
More recent estimates of the seroprevalence stratified by age are needed in routine care to enable definition of pre-test probability for this serological test in the clinical evaluation of children with suspected Lyme disease. Since an age dependant relationship is plausible and has been shown in studies, seroprevalence estimates from adults should not be used in children. Knowledge of the seroprevalence of B. burgdorferi in children will help to better differentiate between active Lyme disease and seroprevalence due to previous Borrelia infection without signs of active disease. This is also important for avoiding overtreatment of children without active diseases. Only a small amount of plasma or serum is needed to determine the B. burgdorferi antibodies. Therefore, this study aims to evaluate the seroprevalence B. burgdorferi antibodies from left-over blood samples that were taken for other clinically relevant tests without an additional invasive procedure for the child.
- Conditions
- B. Burgdorferi Infection
- Keywords
- children, adolescents
- Medical subject headings
- Lyme Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Assesment of B.burgdorferi antibodies in children and adolescents
Analysis of blood samples using B. burgdorferi Immunoglobulin G ELISA test and line blot for confirmation.
A positive serology for B. burgdorferi will be defined as a positive Immunglobulin G (IgG) enzyme-linked immunoassay (ELISA) test for B. burgdorferi and a positive confirmation test by Line Blot (similar to a western blot technique).
Measured: one time assessment at baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2023
- Study start23 Jun 2023
- Primary completion6 Feb 2024
- Study completion6 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for B. Burgdorferi InfectionStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 962 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Children's Hospital Basel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ulrich Heininger, Prof., Principal investigator, University Childrens Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05856812
- Sponsor's protocol ID
- 2022-02143; ks23Heininger
- Acronym
- BOBUINCA
- Status last verified
- Nov 2024
- First submitted
- 26 Apr 2023
- Last updated
- 26 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Heeb L, Fritschi N, Marten A, Welzel T, Ritz N, Heininger U. Borrelia burgdorferi infections in children and adolescents in Switzerland - a seroprevalence study 2023/2024 (BOBUINCA). Infection. 2025 Jun;53(3):893-903. doi: 10.1007/s15010-024-02387-7. Epub 2024 Sep 26.
PubMed 39325354
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BOrrelia BUrgdorferi IN Children and Adolescents- a Seroprevalence Study
- ClinicalTrials.gov ID
- NCT05856812
- Acronym / sponsor ID
- BOBUINCA / 2022-02143; ks23Heininger
- Conditions
- B. Burgdorferi Infection
- Keywords
- children, adolescents
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 962 participants (actual)
- Lead sponsor
- University Children's Hospital BaselUniversity, hospital or other
- Study start
- 23 Jun 2023 (actual)
- Primary completion
- 6 Feb 2024 (actual)
- Study completion
- 6 Feb 2024 (actual)
- First posted
- 12 May 2023 (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.
The aim of this study is to assess B. burgdorferi antibodies in children and adolescents in north-western Switzerland and neighbouring countries ("Triregio") treated at the University Children's Hospital Basel to define age-dependent B. burgdorferi seroprevalence rates.
Detailed description
Lyme borreliosis is one of the most prevalent tick-borne zoonosis in the northern hemisphere. Children with Borrelia (B.) burgdorferi infection present with different clinical stages and related symptoms: an early localized stage is commonly associated with an erythema migrans or a borrelial lymphocytoma. Early disseminated disease include early neuroborreliosis, acute arthritis or carditis. Later disease stages include acrodermatitis chronica atrophicans, late neuroborreliosis or Lyme Arthritis. B. burgdorferi prevalence is highest in Europe and has been increasing in the last decade.
Only limited data about the seroprevalence in children is available. A recently published systematic review and meta-analysis estimated the overall global seroprevalence at 14.5% (95% confidence interval (CI) 12.8-16.3%), and at 7.1% (95% CI 5.1-9.5%) in those <40 years of age (based on 18 studies). Only a few studies included in this systematic review assessed paediatric cohorts in Europe: One study from Germany was published 10 years ago and estimated the seroprevalence at 4.5% (95% CI 4.3-5.4%) in the age group 1-17 years. The seroprevalence was higher in males and in the southern part of Germany, and it increased by 11% and 6% for every year of age in boys and girls, respectively. A study from Sweden looked at 5-year old children and estimated a seroprevalence of 3.2%. More data about the seroprevalence is available in adults with heterogenous findings: recent studies from southern Germany, eastern Slovakia, Jordan, Finland and Romania, reported seroprevalence values of 2.4%, 13%, 11.7%, 3.9% and 7.4% respectively.
More recent estimates of the seroprevalence stratified by age are needed in routine care to enable definition of pre-test probability for this serological test in the clinical evaluation of children with suspected Lyme disease. Since an age dependant relationship is plausible and has been shown in studies, seroprevalence estimates from adults should not be used in children. Knowledge of the seroprevalence of B. burgdorferi in children will help to better differentiate between active Lyme disease and seroprevalence due to previous Borrelia infection without signs of active disease. This is also important for avoiding overtreatment of children without active diseases. Only a small amount of plasma or serum is needed to determine the B. burgdorferi antibodies. Therefore, this study aims to evaluate the seroprevalence B. burgdorferi antibodies from left-over blood samples that were taken for other clinically relevant tests without an additional invasive procedure for the child.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 year to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- The study population will include children and adolescents, who presented at the University Childrens Hospital Basel in outpatient or inpatient setting. All children and adolescents, from whom a sufficient left over amount of the EDTA sample taken for clinical routine tests at the hematology laboratory of the University Childrens Hospital Basel will be included
Key inclusion criteria (2 listed)
- signed informed general consent
- residence in cantons Basel city, Basel country, Aargau, Solothurn and neighboring areas of France and Germany (Germany postal codes 794x, 795x, 796x, 797x and France postal codes 68480, 68640, 68220, 68330, 68300, 68128, 68730, 68870, 68510, 68130, 68640, 68960, 56890, 68118, 68580, 68680, 68440, 68720)
Key exclusion criteria (10 listed)
- case blood is taken repetitively from the same child, only the first sample will be used and the child will only be included in the study once.
- Refugees seeking asylum will be excluded. These children will be identified by postal address of the Bundesasylzentrum.
- Children presenting for a diagnosis related to a B. burgdorferi infection will be excluded since including these children would result in an over-estimation of the pre-test prevalence of B. burgdorferi IgG due to a possible selection bias. Diagnosis related to a B. burgdorferi infection will include erythema migrans, borrelial lymphocytoma, early or late neuroborreliosis, acute arthritis or carditis, acrodermatitis chronica atrophicans.
- Children with underlying chronic disease, that potentially affects plasma antibodies will be excluded, these include for example the following conditions:
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
Assesment of B.burgdorferi antibodies in children and adolescents
Time frame: one time assessment at baseline
Analysis of blood samples using B. burgdorferi Immunoglobulin G ELISA test and line blot for confirmation. A positive serology for B. burgdorferi will be defined as a positive Immunglobulin G (IgG) enzyme-linked immunoassay (ELISA) test for B. burgdorferi and a positive confirmation test by Line Blot (similar to a western blot technique).
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 26 Nov 2024.
- Background: PubMed 39325354Heeb L, Fritschi N, Marten A, Welzel T, Ritz N, Heininger U. Borrelia burgdorferi infections in children and adolescents in Switzerland - a seroprevalence study 2023/2024 (BOBUINCA). Infection. 2025 Jun;53(3):893-903. doi: 10.1007/s15010-024-02387-7. Epub 2024 Sep 26.
Related trials for B. Burgdorferi Infection
RecruitingObservational study
Natural History of Trisomy 8-Associated Autoinflammatory Disease (TRIAD) and Related Disorders
Trisomy 8 Mosaicism, Trisomy 8 Associated Autoinflammatory Disease
RecruitingObservational study
Evaluation, Treatment, and Follow-up of Patients With Lyme Disease
Lyme Disease
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Recruiting
Sana Device for Post-Treatment Lyme Disease Syndrome Chronic Pain
Post-treatment Lyme Disease Syndrome, Chronic Pain
RecruitingObservational study
FINtick - a Prospective Multicenter Study on Tick-borne Infections in Finland
Tick Borne Encephalitis (TBE), Lyme Borreliosis
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.
Ulrich Heininger, Prof. principal investigator
University Childrens Hospital
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 B. Burgdorferi Infection, run by University Children's Hospital Basel at 1 site in Switzerland.
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 2 inclusion and 10 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 26 Nov 2024. 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 Switzerland. 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?
Assesment of B.burgdorferi antibodies in children and adolescents (time frame: one time assessment at baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05856812, which also lists 1 linked publication.
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 26 Nov 2024.