Lyme borreliosis Lyme disease
Conditions
Interventions
None listed
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Healthy controls (1a): no specific inclusion criteria;Potentially cross-reactive controls (1b): one of several infectious or inflammatory diseases with criteria depending on the disease in question;Patients with disseminated Lyme borreliosis (1c): must have a confirmed diagnosis of disseminated LB (e.g., Lyme arthritis, neuroborreliosis, acrodermatitis chronica atroficans, Lyme-carditis), with clinical and laboratory criteria largely based on the case definitions of ESGBOR and published by Stanek and colleagues and must not have started treatment for the LB at the moment of inclusion or at most one week prior to the moment of inclusion. ;Cohort study (2): patients presenting at the specialized Lyme centers of the AMC or Radboudumc
Exclusion criteria
Exclusion criteria: Healthy controls (1a): current Lyme borreliosis, having certain factors that may impair immunity (e.g., immunosuppressants or known immunodeficiency);Potentially cross-reactive controls (1b): ever an episode of Lyme borreliosis, recent tick bite, more than one potentially cross-reactive condition, having certain factors that may impair immunity (see above);Patients with disseminated Lyme borreliosis (1c): Signs or symptoms at inclusion attributed to a previous episode of LB.;Cohort study (2): no specific exclusion criteria
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| As primary study endpoint, we will report the diagnostic parameters (i.e. sensitivity and specificity) of the cellular tests. | — |
Secondary
| Measure | Time frame |
|---|---|
| Since these tests are performed before and after antibiotic treatment, we will also assess whether such tests have the potential to be used as point-of-cure tests. We will compare the results of the cellular tests to existing serological tests. In addition, we will investigate the added value of cellular tests in patients referred to our specialized academic Lyme centers. | — |
Countries
Netherlands
Outcome results
None listed