| NCT ID | NCT06045416 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Children's Hospital, Zurich |
| Condition | Lyme Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 502 participants |
| Start Date | 2024-04-02 |
| Primary Completion | 2026-11-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 502 participants in total. It began in 2024-04-02 with a primary completion date of 2026-11-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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: 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.
Eligibility Criteria
Inclusion Criteria: * Patients presenting at the ED with differential diagnosis of LD according to the treating physician Exclusion Criteria: * Patients will be excluded in cases of primary or secondary immunodeficiency
Contact & Investigator
Patrick M Meyer Sauteur, MD PhD
PRINCIPAL INVESTIGATOR
Division of infectious diseases Univesity Children's Hospital Zurich
Frequently Asked Questions
Who can join the NCT06045416 clinical trial?
This trial is open to participants of all sexes, aged 1 Month or older, up to 17 Years, studying Lyme Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06045416 currently recruiting?
Yes, NCT06045416 is actively recruiting participants. Contact the research team at patrick.meyersauteur@kispi.uzh.ch for enrollment information.
Where is the NCT06045416 trial being conducted?
This trial is being conducted at Zurich, Switzerland.
Who is sponsoring the NCT06045416 clinical trial?
NCT06045416 is sponsored by University Children's Hospital, Zurich. The principal investigator is Patrick M Meyer Sauteur, MD PhD at Division of infectious diseases Univesity Children's Hospital Zurich. The trial plans to enroll 502 participants.