Aseptic Meningoencephalitis in Slovenia

Sponsor

University Medical Centre Ljubljana (Other)

Overall Status

Unknown status

CT.gov ID

NCT02328469

Collaborator

Slovenian Research Agency (Other), University of Ljubljana School of Medicine, Slovenia (Other), Harvard University (Other)

800

Enrollment

Locations

Duration (Months)

400

Patients Per Site

5.6

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Aseptic Meningitis	Drug: symptomatic therapy Drug: Ceftriaxone or Doxycycline Other: questionnaire Drug: Acyclovir

Study Design

Study Type:

Observational

Anticipated Enrollment :

800 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

Prospective Study of the Etiology, Pathogenesis, Clinical Picture and Outcome of Aseptic Meningitis in Slovenia

Study Start Date :

Jun 1, 2014

Anticipated Primary Completion Date :

Jun 1, 2020

Anticipated Study Completion Date :

Jun 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
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 patients will receive symptomatic therapy with antipyretics, analgetics, antiemetics and parenteral hydration: metamizole, paracetamol, thiethylperazine, saline Other: 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.	Drug: symptomatic therapy patients will receive symptomatic therapy with antipyretics, analgetics, antiemetics and parenteral hydration: metamizole, paracetamol, thiethylperazine, saline Other: 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.	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.
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 patients will receive symptomatic therapy with antipyretics, analgetics, antiemetics and parenteral hydration: metamizole, paracetamol, thiethylperazine, saline Other: 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.	Drug: symptomatic therapy patients will receive symptomatic therapy with antipyretics, analgetics, antiemetics and parenteral hydration: metamizole, paracetamol, thiethylperazine, saline 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.

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Infectious Diseases, University Medical Center Ljubljana, Ljubljana, Slovenia	Ljubljana		Slovenia	1525
2	UMC Ljubljana, Department of Infectious Diseases	Ljubljana		Slovenia	1525