Aseptic Meningoencephalitis in Slovenia

Overview

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

Full Title of Study: “Prospective Study of the Etiology, Pathogenesis, Clinical Picture and Outcome of Aseptic Meningitis in Slovenia”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: June 2020

Interventions

  • Drug: symptomatic therapy
    • patients will receive symptomatic therapy with antipyretics, analgetics, antiemetics and parenteral hydration: metamizole, paracetamol, thiethylperazine, saline
  • Drug: Ceftriaxone or Doxycycline
    • beside symptomatic therapy (metamizole, paracetamol, thiethylperazine, saline), patients with proven or probable Lyme neuroborreliosis will be treated with ceftriaxone 2 g intravenously once daily for 14 days OR doxycycline 100 mg orally twice daily for 14 days
  • Other: questionnaire
    • Control subjects will be asked to answer a questionnaire asking about the presence and frequency of nonspecific symptoms.
  • Drug: Acyclovir
    • Patients will be treated with intravenous acyclovir 10 mg per kg three times daily for 14 to 21 days.

Arms, Groups and Cohorts

  • unidentified aseptic meningitis
    • Patients with etiologically unidentified aseptic meningitis will be treated with symptomatic therapy and will be asked to complete a questionnaire.
  • 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.
  • 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.
  • 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.
  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • Changes in selected clinical parameters in patients with acute aseptic meningitis/meningoencephalitis
    • Time Frame: 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 laboratory parameters in patients with acute aseptic meningitis/meningoencephalitis
    • Time Frame: 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.
  • Changes in selected microbiologic parameters in patients with acute aseptic meningitis/meningoencephalitis
    • Time Frame: 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.

Participating in This Clinical Trial

Inclusion Criteria

  • 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)

Exclusion Criteria

  • younger than 18 years
  • pregnant women

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • University Medical Centre Ljubljana
  • Collaborator
    • Slovenian Research Agency
  • Provider of Information About this Clinical Study
    • Principal Investigator: Franc Strle, MD PhD – University Medical Centre Ljubljana
  • Overall Official(s)
    • Franc Strle, MD, PhD, Study Chair, UMC Ljubljana
    • Daša Stupica, MD, PhD, Principal Investigator, UMC Ljubljana
  • Overall Contact(s)
    • Daša Stupica, MD, PhD, +386 1 5222110, dasa.stupica@kclj.si

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