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Borrelia B-cell Diagnostics

Study acronym: BRILLIANT
StatusRecruiting
PhaseNot specified
Started
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Record History

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  1. Minor 2 versions Re-verified since Jan 6, 2025, no change to tracked fieldsv5-v6
  2. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Apr 1, 2024 to Apr 2, 2024
    • Site details revised
    v4
  3. Notable Start date: Nov 1, 2023 to Apr 1, 2024v3
  4. Notable Primary endpoint revised
    • Secondary endpoints: 2 to 5
    • Study description expanded, about 3 words
    v2
  5. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06045416
Lead Sponsor University Children's Hospital, Zurich
Collaborators: University of Zurich
Conditions
(from sponsor)
Lyme Disease, Borrelia Infections
Related terms Borrelia Infections, Lyme Disease
Enrollment 502 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov