Aseptic Meningoencephalitis in Slovenia

NCT02328469 | Unknown

• 1 other identifier: mgt-0614
• Study Type: observational
• Target: 800
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Aseptic Meningitis

Keywords

aseptic meningitis; tick-borne encephalitis; Lyme neuroborreliosis; inflammation; outcome

Outcome Measures

Primary Outcomes (3)

• Changes in selected clinical parameters in patients with acute aseptic meningitis/meningoencephalitis

  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.

  at enrollment and during 12 months follow-up

• Changes in selected laboratory parameters in patients with acute aseptic meningitis/meningoencephalitis

  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.

  at enrollment and during 12 months follow-up

• Changes in selected microbiologic parameters in patients with acute aseptic meningitis/meningoencephalitis

  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.

  at enrollment and during 12 months follow-up

Study Arms (5)

unidentified aseptic meningitis

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

Drug: symptomatic therapy; Other: 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.

Drug: symptomatic therapy; Other: 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.

Drug: symptomatic therapy; Drug: Ceftriaxone or Doxycycline; Other: 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.

Drug: symptomatic therapy; Other: questionnaire

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.

Drug: symptomatic therapy; Other: questionnaire; Drug: Acyclovir

Interventions

symptomatic therapy DRUG

patients will receive symptomatic therapy with antipyretics, analgetics, antiemetics and parenteral hydration: metamizole, paracetamol, thiethylperazine, saline

Lyme neuroborreliosis; healthy controls; identified aseptic meningitis; tick-borne encephalitis; unidentified aseptic meningitis

Ceftriaxone or Doxycycline DRUG

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

Lyme neuroborreliosis

questionnaire OTHER

Control subjects will be asked to answer a questionnaire asking about the presence and frequency of nonspecific symptoms.

Lyme neuroborreliosis; healthy controls; identified aseptic meningitis; tick-borne encephalitis; unidentified aseptic meningitis

Acyclovir DRUG

Patients will be treated with intravenous acyclovir 10 mg per kg three times daily for 14 to 21 days.

identified aseptic meningitis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

adult patients with acute aseptic meningitis/meningoencephalitis

You may qualify if:

• 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)

You may not qualify if:

• younger than 18 years
• pregnant women

Sponsors & Collaborators

• University Medical Centre Ljubljana: lead
• Slovenian Research Agency: collaborator
• University of Ljubljana School of Medicine, Slovenia: collaborator
• Harvard University: collaborator

Study Sites (2)

Department of Infectious Diseases, University Medical Center Ljubljana, Ljubljana, Slovenia

Ljubljana, 1525, Slovenia

RECRUITING

UMC Ljubljana, Department of Infectious Diseases

Ljubljana, 1525, Slovenia

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Samples of full blood, serum and plasma will be collected and retained in deep freezer for further analyses.

MeSH Terms

Conditions

Meningitis, Aseptic; Encephalitis, Tick-Borne; Lyme Neuroborreliosis; Inflammation

Interventions

Ceftriaxone; Doxycycline; Surveys and Questionnaires; Acyclovir

Condition Hierarchy (Ancestors)

Meningitis; Neuroinflammatory Diseases; Nervous System Diseases; Encephalitis, Arbovirus; Encephalitis, Viral; Central Nervous System Viral Diseases; Central Nervous System Infections; Infections; Infectious Encephalitis; Arbovirus Infections; Vector Borne Diseases; Tick-Borne Diseases; Virus Diseases; RNA Virus Infections; Flavivirus Infections; Flaviviridae Infections; Encephalitis; Brain Diseases; Central Nervous System Diseases; Central Nervous System Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Lyme Disease; Gram-Negative Bacterial Infections; Borrelia Infections; Spirochaetales Infections; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cefotaxime; Cephacetrile; Cephalosporins; beta-Lactams; Lactams; Amides; Organic Chemicals; Thiazines; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Guanine; Hypoxanthines; Purinones; Purines

Study Officials

• Franc Strle, MD, PhD

  UMC Ljubljana

  STUDY CHAIR

• Daša Stupica, MD, PhD

  UMC Ljubljana

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Daša Stupica, MD, PhD

CONTACT

+386 1 5222110; dasa.stupica@kclj.si

Franc Strle, MD, PhD

CONTACT

+386 1 5222610; franc.strle@kclj.si

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD PhD

Study Record Dates

• First Submitted: May 27, 2014
• First Posted: December 31, 2014
• Study Start: June 1, 2014
• Primary Completion: June 1, 2020
• Study Completion: June 1, 2020
• Last Updated: May 4, 2018

Record last verified: 2018-05

Locations

SL (2)