Lyme borreliosis Lyme disease
Conditions
Interventions
None listed
Sponsors
Radboud Universitair Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Patients with acute localized infection: - Patients must be 18 years or older; - Must have a confirmed erythema migrans (EM) with a diameter of more than or 5 cm that has been present for less than a week, the diagnosis being confirmed by the treating physician after inclusion; - Have not yet started treatment for the lyme borreliosis (LB) at the moment of inclusion or at most one week prior to the moment of inclusion; - Do not have signs or symptoms at inclusion attributed to a previous episode of Lyme borreliosis; - If the patient has presented with EM's or Lyme borreliosis related symptoms before inclusion, but no longer have, this will be recorded in their patient file/through the questionnaire. Patients with disseminated or post-treatment lyme borreliosis syndrome (PTLBS): - Patients must be 18 years or older; - Must have a conflrmed diagnosis of Lyme borreliosis, with clinical and laboratory criteria largely based on the case definitions of ESGBOR and published by Stanek et al.; - Must have started treatment at most 1 week before inclusion. Healthy controls: - Patients must be 18 years or older; - Patients must have bacterial skin/soft tissue infections (e.g. erysipelas, cellulitis) and they must have a confirmed diagnosis according to the leading guidelines. Cross-reactive controls: - Patients must be 18 years or older; - Patients must be diagnosed with either erysipelas or cellulitis
Exclusion criteria
Exclusion criteria: Patients with acute and localized LB or disseminated LB/PTLBS: - Suffering from other tick-borne or infectious diseases; - Suffering from severe immunological deficiencies that result in consistent immunosuppression; - The use of immunosuppressive medication before, during and/or after infection; - The use of immunomodulating medication including > 7,5 mg prednisone daily, methotrexate, biologicals; - Unable to give informed consent or do not have a thorough command of the Dutch language. Healthy controls: - Unable to give informed consent or do not have a thorough command of the Dutch language; - Suffering from other tick-borne or infectious diseases, HIV seropositivity if known, active syphilis or leptospirosis, an active infection with EBV/CMV; - Suffering from auto-immune disease if known - The use of immunosuppressive medication before, during and after Borrelia infection occurred; - The use of immunomodulating medication including > 7,5 mg prednisone daily, methotrexate, biologicals; - Severe immunological defìciencies that result in consistent immunosuppression. - Known (severe) immunodeficiencies, hematologic malignancies in the medical history or chemotherapy in the last year; - Current LB with typical symptoms; - Other co-morbidities such as auto-immune diseases, severe acute and chronic infections. Cross-reactive controls: - Unable to give informed consent or do not have a thorough command of the Dutch language; - Suffering from other tick-borne diseases; - The use of immunomodulating medication including > 7,5 mg prednisone daily, methotrexate, biologicals, consistent immunosuppression; - Other co-morbidities.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess immunological changes in patients with acute, early Lyme borreliosis. The main parameters and endpoints are immunological determinants such as the expression of antigen presentation markers (e.g. CD74, HLA-DR, HLA-DM) and the adaptive immune response by measuring cytokine production. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) To determine the role and mechanism of antigen presentation inhibition in the development of acute, early Borrelia infection and disseminated Lyme disease in patients. 2) To assess thê impact of immunological changes on acute, localized, early and late disseminated Lyme borreliosis. 3) To study the effect of Borrelia-induced antigen presentation inhibition on the adaptive immune response. 4) To evaluate which changes in confirmed patients are still existent several months after diagnosis and/or treatment. | — |
Countries
Netherlands
Outcome results
None listed