Prospective Study of the Etiology, Pathogenesis, Clinical Picture and Outcome of Aseptic Meningitis in Slovenia
试验速览
- 阶段
- 不适用
- 入组人数
- 800
- 试验地点
- 2
- 主要终点
- Changes in selected clinical parameters in patients with acute aseptic meningitis/meningoencephalitis
研究概览
简要总结
The main objective of this study is:
- to establish etiology of acute aseptic meningitis/meningoencephalitis in Slovenia
- to assess the clinical course and outcome of tick-borne encephalitis and Lyme neuroborreliosis
- to characterize the inflammatory proteins, gene polymorphisms, and transcriptome profiles in patients with tick-borne encephalitis and Lyme neuroborreliosis
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
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
- •clinical picture compatible with aseptic meningitis/meningoencephalitis
- •age 18 years or older
- •clear cerebrospinal fluid on macroscopic examination
- •cerebrospinal pleocytosis (> 5 x 106 white blood cells per liter)
排除标准
- •younger than 18 years
- •pregnant women
研究组 & 干预措施
unidentified aseptic meningitis
Patients with etiologically unidentified aseptic meningitis will be treated with symptomatic therapy and will be asked to complete a questionnaire.
干预措施: symptomatic therapy (Drug)
unidentified aseptic meningitis
Patients with etiologically unidentified aseptic meningitis will be treated with symptomatic therapy and will be asked to complete a questionnaire.
干预措施: questionnaire (Other)
tick-borne encephalitis
Patient with aseptic meningitis in whom serological diagnosis of tick-borne encephalitis will be established. Patients will be treated with symptomatic therapy and will be asked to complete a questionnaire.
干预措施: symptomatic therapy (Drug)
tick-borne encephalitis
Patient with aseptic meningitis in whom serological diagnosis of tick-borne encephalitis will be established. Patients will be treated with symptomatic therapy and will be asked to complete a questionnaire.
干预措施: questionnaire (Other)
Lyme neuroborreliosis
Patients with acute aseptic meningitis in whom Lyme neuroborreliosis will be proven or suspected according to microbiological criteria. Patients will be treated with antibiotic therapy (ceftriaxone or doxycycline) and will be asked to complete a questionnaire.
干预措施: symptomatic therapy (Drug)
Lyme neuroborreliosis
Patients with acute aseptic meningitis in whom Lyme neuroborreliosis will be proven or suspected according to microbiological criteria. Patients will be treated with antibiotic therapy (ceftriaxone or doxycycline) and will be asked to complete a questionnaire.
干预措施: Ceftriaxone or Doxycycline (Drug)
Lyme neuroborreliosis
Patients with acute aseptic meningitis in whom Lyme neuroborreliosis will be proven or suspected according to microbiological criteria. Patients will be treated with antibiotic therapy (ceftriaxone or doxycycline) and will be asked to complete a questionnaire.
干预措施: questionnaire (Other)
healthy controls
Patients will be asked to refer a spouse to serve as a control . If unmarried they will be asked to refer a family member or a friend of +/- 5 years to serve as a control.
干预措施: symptomatic therapy (Drug)
healthy controls
Patients will be asked to refer a spouse to serve as a control . If unmarried they will be asked to refer a family member or a friend of +/- 5 years to serve as a control.
干预措施: questionnaire (Other)
identified aseptic meningitis
Patients with microbiologically identified cause of acute aseptic meningitis/meningoencephalitis will receive symptomatic therapy. If the identified causative agent will be Herpes Simplex Virus or Varicella Zoster Virus, patients will be treated with acyclovir and will be asked to complete a questionnaire.
干预措施: symptomatic therapy (Drug)
identified aseptic meningitis
Patients with microbiologically identified cause of acute aseptic meningitis/meningoencephalitis will receive symptomatic therapy. If the identified causative agent will be Herpes Simplex Virus or Varicella Zoster Virus, patients will be treated with acyclovir and will be asked to complete a questionnaire.
干预措施: questionnaire (Other)
identified aseptic meningitis
Patients with microbiologically identified cause of acute aseptic meningitis/meningoencephalitis will receive symptomatic therapy. If the identified causative agent will be Herpes Simplex Virus or Varicella Zoster Virus, patients will be treated with acyclovir and will be asked to complete a questionnaire.
干预措施: Acyclovir (Drug)
结局指标
主要结局
Changes in selected clinical parameters in patients with acute aseptic meningitis/meningoencephalitis
时间窗: at enrollment and during 12 months follow-up
Selected clinical parameters (presence or absence of headache, nausea, vomiting, neurologic symptoms, maximal temperature, etc) in aseptic meningitis/meningoencephalitis patients at enrollment (at admission to hospital) and at follow-up visits: on day 7 or on day of discharge from hospital, on day 14, at 2, 6, and 12 months.
Changes in selected microbiologic parameters in patients with acute aseptic meningitis/meningoencephalitis
时间窗: at enrollment and during 12 months follow-up
Selected microbiologic parameters (anti Borrelia burgdorferi immunoglobulin M and G in serum and cerebrospinal fluid results, polymerase chain reaction for enteroviruses, herpes simplex virus type 1 and 2 in cerebrospinal fluid results) in aseptic meningitis/meningoencephalitis patients at enrollment (at admission to hospital) and anti Borrelia burgdorferi immunoglobulin M and G in serum at follow-up visits: at 2, 6, and 12 months.
Changes in selected laboratory parameters in patients with acute aseptic meningitis/meningoencephalitis
时间窗: at enrollment and during 12 months follow-up
Selected laboratory parameters (complete blood count, biochemistry test results) in aseptic meningitis/meningoencephalitis patients at enrollment (at admission to hospital) and at follow-up visits: on day 7 or on day of discharge from hospital, on day 14, at 2, 6, and 12 months.
次要结局
未报告次要终点
研究者
Franc Strle
MD PhD
University Medical Centre Ljubljana