Borrelia B-cell Diagnostics

Sponsor
University Children's Hospital, Zurich
Study ID
NCT06045416
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
1 Month - 17 Years
Healthy Volunteers
Accepted

Interventions

  • venous blood puncture — PROCEDURE
    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.

Study Details

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: 1. Development of Bb-specific ASC ELISpot as a new test method for diagnosis of early LD. There is an urgent unmet clinical need for a better diagnostic tool for early LD, as the current standard two-tier testing has low sensitivity in recently infected patients and may show false positive results in recovered patients due to long-term persistence of antibodies against Bb. The measurement of Bb-specific ASC with the ELISpot assay my has the potential to overcome these issues and to improve diagnosis in early LD. 2. Extensive analysis of the immune response in LD. The immune response in LD is not well understood. Large-scale studies assessing the detailed immune cell subsets/phenotypes present in blood, CSF, or synovial fluid of LD patients with respective manifestations are lacking. 3. Isolation and characterization of causative Bb species. Existing literature suggests that Bb genospecies and/or genotypes may determine virulence and manifestations, but large-scale studies assessing Bb genospecies/genotypes in different manifestation of LD are lacking. 4. Collection of clinical data about symptoms, severity, routine laboratory and diagnostic test results, treatment, and outcome of LD. 5. Biobanking samples for analysis in the future. Project population Inclusion criteria: Children, 0-17 years of age, at University Children's Hospital Zurich: * 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.

Key Dates

Start date
Apr 2, 2024
Status verified
Apr 2026
Primary completion
Nov 1, 2026
Completion
Nov 1, 2028

Study Design

Enrollment
502 participants (estimated)

Arms

  • Arm: LD_Diff_Diag
    LD differential diagnosis cohort: Patients presenting at the ED with differential diagnosis of LD according to the treating physician
  • Arm: Heathy_Control
    Previously healthy patients (HC) with routine blood investigations presenting at the ED or PID outpatient department

Primary Outcome Measure

Number of Bb-specific ASCs per 10^6 PBMCs [ Time Frame: 10/2023 - 10/2026 ]

Central Contacts

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