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Aseptic Meningoencephalitis in Slovenia

U

University Medical Centre Ljubljana

Status

Unknown

Conditions

Aseptic Meningitis

Treatments

Drug: symptomatic therapy
Drug: Ceftriaxone or Doxycycline
Other: questionnaire
Drug: Acyclovir

Study type

Observational

Funder types

Other

Identifiers

NCT02328469
mgt-0614

Details and patient eligibility

About

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

Enrollment

800 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

800 participants in 5 patient groups

unidentified aseptic meningitis
Description:
Patients with etiologically unidentified aseptic meningitis will be treated with symptomatic therapy and will be asked to complete a questionnaire.
Treatment:
Drug: symptomatic therapy
Other: questionnaire
tick-borne encephalitis
Description:
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.
Treatment:
Drug: symptomatic therapy
Other: questionnaire
Lyme neuroborreliosis
Description:
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.
Treatment:
Drug: symptomatic therapy
Other: questionnaire
Drug: Ceftriaxone or Doxycycline
healthy controls
Description:
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.
Treatment:
Drug: symptomatic therapy
Other: questionnaire
identified aseptic meningitis
Description:
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.
Treatment:
Drug: symptomatic therapy
Other: questionnaire
Drug: Acyclovir

Trial contacts and locations

2

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Central trial contact

Franc Strle, MD, PhD; Daša Stupica, MD, PhD

Data sourced from clinicaltrials.gov

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