Assessing immune response in children with Lyme disease
Official title: Extensive Investigation of Immune Responses Against Borrelia Burgdorferi to Improve Diagnosis of Lyme Disease in Children: an Observational Study (BRILLIANT Study)
Run by University Children's Hospital, Zurich · NCT06045416 · Data updated 2026-11-12
This study is testing a new blood test to see how children's immune systems respond to Lyme disease to help doctors diagnose it earlier and better.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 1 Month to 17 Years |
| Sex | All |
| Enrollment | 502 (estimated) |
| Sponsor | University Children's Hospital, Zurich Academic / other |
| Locations | 1 site (Zurich) |
| Status | Recruiting |
| Started | April 2, 2024 |
| Main results expected | November 1, 2026 |
| Study ends | November 1, 2028 |
| Registry record updated | April 28, 2026 |
| Trial ID | NCT06045416 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are children aged 0-17 years presenting with symptoms indicative of Lyme disease.
✕Probably not a fit
Patients with primary or secondary immunodeficiency will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to evaluate the immune response against Borrelia burgdorferi in children diagnosed with Lyme disease. It will develop a new diagnostic tool using the Bb-specific ASC ELISpot assay to improve early diagnosis, addressing the limitations of current testing methods. The study will enroll 502 patients aged 0-17 years who present with symptoms suggestive of Lyme disease, alongside healthy controls. Blood samples will be collected at initial hospital visits and follow-up appointments to analyze immune cell responses.
Why it matters
Potential benefit: If successful, this study could lead to improved diagnostic methods for early Lyme disease, potentially reducing misdiagnosis and treatment delays.
How similar studies have gone: While there have been studies on Lyme disease diagnostics, the specific approach of using Bb-specific ASC ELISpot is novel and has not been extensively tested.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
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Chidren's Hospital Zurich
Zurich, Switzerland Recruiting
Study contacts
- Principal investigator: Patrick M Meyer Sauteur, MD PhD — Division of infectious diseases Univesity Children's Hospital Zurich
- Study coordinator: Patrick M Meyer Sauteur, MD PhD
- Email: patrick.meyersauteur@kispi.uzh.ch
- Phone: 0041 44 266 78 96
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.