Assessing immune response in children with Lyme disease
Extensive Investigation of Immune Responses Against Borrelia Burgdorferi to Improve Diagnosis of Lyme Disease in Children: an Observational Study (BRILLIANT Study)
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 |
|---|---|
| Enrollment | 502 (estimated) |
| Ages | 1 Month to 17 Years |
| Sex | All |
| Sponsor | University Children's Hospital, Zurich Academic / other |
| Locations | 1 site (Zurich) |
| Trial ID | NCT06045416 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are children aged 0-17 years presenting with symptoms indicative of Lyme disease.
Not a fit: Patients with primary or secondary immunodeficiency will not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Zurich
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.