Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
800 participants
OBSERVATIONAL
2014-06-30
2020-06-30
Brief Summary
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* 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
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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unidentified aseptic meningitis
Patients with etiologically unidentified aseptic meningitis will be treated with symptomatic therapy and will be asked to complete a questionnaire.
symptomatic therapy
patients will receive symptomatic therapy with antipyretics, analgetics, antiemetics and parenteral hydration: metamizole, paracetamol, thiethylperazine, saline
questionnaire
Control subjects will be asked to answer a questionnaire asking about the presence and frequency of nonspecific symptoms.
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.
symptomatic therapy
patients will receive symptomatic therapy with antipyretics, analgetics, antiemetics and parenteral hydration: metamizole, paracetamol, thiethylperazine, saline
questionnaire
Control subjects will be asked to answer a questionnaire asking about the presence and frequency of nonspecific symptoms.
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.
symptomatic therapy
patients will receive symptomatic therapy with antipyretics, analgetics, antiemetics and parenteral hydration: metamizole, paracetamol, thiethylperazine, saline
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
questionnaire
Control subjects will be asked to answer a questionnaire asking about the presence and frequency of nonspecific symptoms.
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.
symptomatic therapy
patients will receive symptomatic therapy with antipyretics, analgetics, antiemetics and parenteral hydration: metamizole, paracetamol, thiethylperazine, saline
questionnaire
Control subjects will be asked to answer a questionnaire asking about the presence and frequency of nonspecific symptoms.
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.
symptomatic therapy
patients will receive symptomatic therapy with antipyretics, analgetics, antiemetics and parenteral hydration: metamizole, paracetamol, thiethylperazine, saline
questionnaire
Control subjects will be asked to answer a questionnaire asking about the presence and frequency of nonspecific symptoms.
Acyclovir
Patients will be treated with intravenous acyclovir 10 mg per kg three times daily for 14 to 21 days.
Interventions
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symptomatic therapy
patients will receive symptomatic therapy with antipyretics, analgetics, antiemetics and parenteral hydration: metamizole, paracetamol, thiethylperazine, saline
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
questionnaire
Control subjects will be asked to answer a questionnaire asking about the presence and frequency of nonspecific symptoms.
Acyclovir
Patients will be treated with intravenous acyclovir 10 mg per kg three times daily for 14 to 21 days.
Eligibility Criteria
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Inclusion Criteria
* age 18 years or older
* clear cerebrospinal fluid on macroscopic examination
* cerebrospinal pleocytosis (\> 5 x 106 white blood cells per liter)
Exclusion Criteria
* pregnant women
18 Years
ALL
Yes
Sponsors
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Slovenian Research Agency
OTHER
University of Ljubljana School of Medicine, Slovenia
OTHER
Harvard University
OTHER
University Medical Centre Ljubljana
OTHER
Responsible Party
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Franc Strle
MD PhD
Principal Investigators
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Franc Strle, MD, PhD
Role: STUDY_CHAIR
UMC Ljubljana
Daša Stupica, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
UMC Ljubljana
Locations
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Department of Infectious Diseases, University Medical Center Ljubljana, Ljubljana, Slovenia
Ljubljana, , Slovenia
UMC Ljubljana, Department of Infectious Diseases
Ljubljana, , Slovenia
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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mgt-0614
Identifier Type: -
Identifier Source: org_study_id
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