Borrelia B-cell Diagnostics
BRILLIANT
Extensive Investigation of Immune Responses Against Borrelia Burgdorferi to Improve Diagnosis of Lyme Disease in Children: an Observational Study (BRILLIANT Study)
1 other identifier
observational
502
1 country
1
Brief Summary
The investigators propose a single center, prospective observational study in children with Lyme disease (LD), the Borrelia B-cell diagnostics (BRILLIANT) study, to assess the immune response against Borrelia burgdorferi (Bb) with the following main objectives:
- LD differential diagnosis cohort: Patients presenting at the ED with differential diagnosis of LD according to the treating physician.
- Control cohort: Previously healthy patients (HC) with routine blood investigations presenting at the ED or PID outpatient department Exclusion criteria: Primary or secondary immunodeficiency.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2024
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 13, 2023
CompletedFirst Posted
Study publicly available on registry
September 21, 2023
CompletedStudy Start
First participant enrolled
April 2, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 1, 2028
April 28, 2026
April 1, 2026
2.6 years
September 13, 2023
April 27, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Bb-specific ASCs per 10^6 PBMCs
Method: Quantification of Bb-specific ASCs (IgM, IgG, IgA) per 10\^6 PBMCs using ELISpot assay Time: 0 d (hospital admission), (1-14 d), 28 d, 3 m, and 6 m (after hospital admission)
10/2023 - 10/2026
Secondary Outcomes (5)
Measurement of percentage and median fluorescence intensity (MFI) of immune cell subsets in blood, CSF and SF
10/2023 - 10/2028
Concentration of serum antibody levels (IU/mL)
10/2023 - 10/2028
Number of Bb-specific T cells per 10^6 PBMCs
10/2023 - 10/2028
Concentration of plasma and CSF cytokine/chemokine levels (pg/mL)
10/2023 - 10/2028
Portion of Bb positive LD patients by culture/PCR, identification of Bb species in LD patients
10/2023 - 10/2028
Study Arms (2)
LD_Diff_Diag
LD differential diagnosis cohort: Patients presenting at the ED with differential diagnosis of LD according to the treating physician
Heathy_Control
Previously healthy patients (HC) with routine blood investigations presenting at the ED or PID outpatient department
Interventions
Venous blood puncture performed at first hospital contact, and at 28 days, 3 month, and 6 months after hospital admission. Lumbar puncture and joint puncture for the study will be performed if it is indicated due to diagnostic or therapeutic reasons.
Eligibility Criteria
Children from 0-17 years of age presenting with signs and symptoms suspicious for LD are included in the study. Previously healthy children with routine blood investigation are enrolled as healthy controls.
You may qualify if:
- Patients presenting at the ED with differential diagnosis of LD according to the treating physician
You may not qualify if:
- Patients will be excluded in cases of primary or secondary immunodeficiency
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Children's Hospital, Zurichlead
- University of Zurichcollaborator
Study Sites (1)
Chidren's Hospital Zurich
Zurich, Switzerland
Biospecimen
Blood, serum and blood separated into plasma and peripheral blood mononuclear cells (PBMCs) (DNA) Cerebrospinal fluid (CSF), separated into CSF and CSF-isolated cells (DNA) Synovial fluid (SF), separated into SF and SF-isolated cells (DNA)
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Patrick M Meyer Sauteur, MD PhD
Division of infectious diseases Univesity Children's Hospital Zurich
- STUDY DIRECTOR
Christoph Berger, MD
Division of infectious diseases Univesity Children's Hospital Zurich
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 6 Months
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 13, 2023
First Posted
September 21, 2023
Study Start
April 2, 2024
Primary Completion (Estimated)
November 1, 2026
Study Completion (Estimated)
November 1, 2028
Last Updated
April 28, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Project data are stored for at least 15 years. Biological data will be collected for 5 years with a start in 2023 until 2028 and destroyed after 10 years of study closure.
- Access Criteria
- Access is authorized to personnel who require the data to fulfil their duties within the scope of the research.
Data will be handled with uttermost discretion and is only accessible to authorized personnel who require the data to fulfil their duties within the scope of the research. On the CRFs and other project specific documents, participants are only identified by a unique participant number. Biological material will be stored in coded manner with unique participant numbers in restricted areas at the Children's Research Center and the IMM. Collaborators will not be granted access to the key or any personal patient information.