Validation of Cellular Tests for Lyme borreliosis
- Conditions
- yme disease (Lyme borreliosis, LB)
- Registration Number
- NL-OMON27274
- Lead Sponsor
- Academic Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 585
CASES
Cases must
1. EITHER report a physician-confirmed erythema migrans (EM) with a diameter larger than 5 cm and that has been present for less than 3 months
2. OR have a confirmed diagnosis of early or late (disseminated) Lyme borreliosis
HEALTHY CONTROLS
No specific inclusion criteria
CROSS-REACTIVE CONTROLS
One of several infectious or inflammatory diseases (Epstein-Bar virus/cytomegalovirus, leptospirosis, syphilis, auto-immune diseases), with criteria depending on the disease in question
OUTPATIENT COHORT
all patients presenting at the specialized Lyme centers of the AMC or Radboudumc.
CASES
Cases must not have started their course of antibiotic treatment more than 4 days (inclusion through self-report on the Tekenradar.nl-website) or more than 7 days (inclusion through participating hospitals) before inclusion.
HEALTHY CONTROLS
Exclusion criteria are current Lyme borreliosis and having certain factors that may impair immunity (e.g., immunosuppressants or known immunodeficiency)
CROSS-REACTIVE CONTROLS
Exclusion criteria are ever having had an episode of Lyme borreliosis, recent tick bite, more than one potentially cross-reactive condition, having certain factors that may impair immunity (see above).
OUTPATIENT COHORT
There are no specific exclusion criteria.
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Diagnostic parameters of the tests <br>The parameters (sensitivity/specificity) of the four cellular tests will be studied in cases and controls.
- Secondary Outcome Measures
Name Time Method