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Aseptic Meningoencephalitis in Slovenia

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ClinicalTrials.gov Identifier: NCT02328469
Recruitment Status : Recruiting
First Posted : December 31, 2014
Last Update Posted : May 12, 2016
Sponsor:
Collaborators:
Slovenian Research Agency
University of Ljubljana School of Medicine, Slovenia
Harvard University
Information provided by (Responsible Party):
Franc Strle, University Medical Centre Ljubljana

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

Study Type : Observational
Estimated 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 : June 2014
Estimated Primary Completion Date : June 2017
Estimated Study Completion Date : June 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Meningitis
U.S. FDA Resources

Group/Cohort 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.



Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Biospecimen Retention:   Samples With DNA
Samples of full blood, serum and plasma will be collected and retained in deep freezer for further analyses.


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
adult patients with acute aseptic meningitis/meningoencephalitis
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02328469


Contacts
Contact: Daša Stupica, MD, PhD +386 1 5222110 dasa.stupica@kclj.si
Contact: Franc Strle, MD, PhD +386 1 5222610 franc.strle@kclj.si

Locations
Slovenia
Department of Infectious Diseases, University Medical Center Ljubljana, Ljubljana, Slovenia Recruiting
Ljubljana, Slovenia, 1525
Contact: Daša Stupica, MD    +386 1 522 2110    dasa.stupica@kclj.si   
Contact: Franc Strle, MD    +386 1 5222610    franc.strle@kclj.si   
Principal Investigator: Daša Stupica, MD         
Sub-Investigator: Franc Strle, MD         
UMC Ljubljana, Department of Infectious Diseases Recruiting
Ljubljana, Slovenia, 1525
Contact: Daša Stupica, MD, PhD    +386 1 522 2110    dasa.stupica@kclj.si   
Contact: Franc Strle, MD, PhD    +386 1 522 2610    franc.strle@kclj.si   
Sponsors and Collaborators
University Medical Centre Ljubljana
Slovenian Research Agency
University of Ljubljana School of Medicine, Slovenia
Harvard University
Investigators
Study Chair: Franc Strle, MD, PhD UMC Ljubljana
Principal Investigator: Daša Stupica, MD, PhD UMC Ljubljana

Responsible Party: Franc Strle, MD PhD, University Medical Centre Ljubljana
ClinicalTrials.gov Identifier: NCT02328469     History of Changes
Other Study ID Numbers: mgt-0614
First Posted: December 31, 2014    Key Record Dates
Last Update Posted: May 12, 2016
Last Verified: May 2016

Keywords provided by Franc Strle, University Medical Centre Ljubljana:
aseptic meningitis
tick-borne encephalitis
Lyme neuroborreliosis
inflammation
outcome

Additional relevant MeSH terms:
Meningitis
Meningitis, Aseptic
Central Nervous System Diseases
Nervous System Diseases
Doxycycline
Ceftriaxone
Acyclovir
Thiethylperazine
Anti-Bacterial Agents
Anti-Infective Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Antiviral Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Dopamine Antagonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action