NL-OMON54756尚未招募不适用
Borrelia-induced inhibition of antigen presentation: a novel escape mechanism from the host defense system. - LymEscape
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 120
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •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
- •- 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
排除标准
- •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
- •- 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.
研究者
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