Does Borrelia Burgdorferi Increases the Risk of Auto-immune Disease ?
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 800
- 试验地点
- 1
- 主要终点
- Occurrence of an autoimmune disease during follow-up
研究概览
简要总结
Lyme borreliosis (LB) is an infectious disease that may be followed by a post-infectious syndrome known as PTLDS: Post-Treatment Lyme Disease Syndrome.
Its pathophysiological mechanism is currently not fully understood, but several hypotheses have been proposed, including the induction of autoimmune phenomena following infection with Borrelia burgdorferi, either due to the bacterium itself or as a consequence of prolonged antibiotic therapy.
The frequency of occurrence of an autoimmune disease (AID) following Lyme borreliosis is currently unknown. Describing its incidence is a necessary first step.
The goal of this observational study is to describe the incidence of autoimmune disease occurring within six months after treated Lyme borreliosis.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult individual who has received full information about the organization of the research and has not objected to the use of their data.
- •Individual included in the TAC TIQUES database.
- •Individual diagnosed with Lyme borreliosis (LB) at the time of their visit to the center or previously, regardless of the stage of LB (localized, early disseminated, or late disseminated).
- •Individual with at least one follow-up consultation six months or more after the LB diagnosis (including cases of erythema migrans treated before the consultation at the Regional Reference Center for Tick-Borne Diseases).
排除标准
- •Individual free of Lyme borreliosis (LB).
- •Individual with a diagnosis of systemic or organ-specific autoimmune disease (AID) prior to the LB diagnosis.
研究组 & 干预措施
TACTIQUES
结局指标
主要结局
Occurrence of an autoimmune disease during follow-up
时间窗: up to six months
Occurrence of any autoimmune disease up to six months after Lyme borreliosis had been treated
次要结局
- To identify factors associated with the occurrence of an autoimmune disease within six months following LB.(up to six months after Lyme borreliosis had been treated, through study completion, up to 4 years)
- Nature of the auto-immune disease(through study completion, up to 4 years)
- To assess the time to onset of an auto-immune disease after Lyme borreliosis(through study completion, up to 4 years)
- Occurrence of an autoimmune disease during follow-up(through study completion, up to 4 years)