Borrelia-induced inhibition of antigen presentation: a novel escape mechanism from the host defense system.
- Conditions
- Lyme borreliosisLyme disease10004018
- Registration Number
- NL-OMON54756
- Lead Sponsor
- Radboud Universitair Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 120
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
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.
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>To assess immunological changes in patients with acute, early Lyme borreliosis.<br /><br>The main parameters and endpoints are immunological determinants such as the<br /><br>expression of antigen presentation markers (e.g.<br /><br>CD74, HLA-DR, HLA-DM) and the adaptive immune response by measuring cytokine<br /><br>production.</p><br>
- Secondary Outcome Measures
Name Time Method <p>1) To determine the role and mechanism of antigen presentation inhibition in<br /><br>the development of acute, early Borrelia infection and<br /><br>disseminated Lyme disease in patients.<br /><br>2) To assess thê impact of immunological changes on acute, localized, early and<br /><br>late disseminated Lyme borreliosis.<br /><br>3) To study the effect of Borrelia-induced antigen presentation inhibition on<br /><br>the adaptive immune response.<br /><br>4) To evaluate which changes in confirmed patients are still existent several<br /><br>months after diagnosis and/or treatment.</p><br>