NCT05742139已完成不适用
Impact Sur la qualité de Vie et symptômes Persistants Des Patients à Distance d'Une neuroborréliose diagnostiquée et traitée
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 159
- 试验地点
- 2
- 主要终点
- Assess the quality of life of patients compared to a healthy control population using the SF-36 questionnaire and the Fatigue Scale Severity
研究概览
简要总结
The link between Lyme neuroborreliosis (NBL) and persistent symptoms is debated in the medical world. Some report a frequency of post NBL symptoms similar to the general population, and others define a specific entity, the PTLDS (Post Treatment Lyme Disease Symptoms).
In France, few studies have evaluated the persistent symptoms and the impact on the quality of life of patients after treatment for NBL.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Have been hospitalized or consulted for neuroborreliosis between 2010 and 2021;
- •Have a diagnosis of probable neuroborreliosis (compatible clinical signs + lumbar puncture with positive intrathecal synthesis of immunoglobulins) or certain (compatible clinical signs + lumbar puncture with pleocytosis and positive intrathecal synthesis of immunoglobulins);
- •Have received adequate treatment according to the recommendations (1st intention DOXYCYCLINE 100mgx2/day or 2nd intention CEFTRIAXONE IV 2g/day for 14 to 21
排除标准
- •Be part of the entourage of the cases;
- •Do not have ATCD of Lyme borreliosis (especially erythema migrans);
- •Not having been bitten by a tick in the last 5 years;
结局指标
主要结局
Assess the quality of life of patients compared to a healthy control population using the SF-36 questionnaire and the Fatigue Scale Severity
时间窗: At inclusion
Identification of symptoms recognized by the patient as persistent after neuroboreliosis from a list of referenced symptoms
时间窗: At inclusion
次要结局
- Comparison of symptoms and/or quality of life between patients with definite versus probable neuroborreliosis using the SF-36 questionnaire(At inclusion)
- Imputability according to the patient of his pain in relation to the initial infection(At inclusion)
研究者
研究点 (2)
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