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Trial record 34 of 64 for:    lyme

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:
Information provided by (Responsible Party):

May 27, 2014
December 31, 2014
May 12, 2016
June 2014
June 2017   (Final data collection date for primary outcome measure)
  • 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.
  • 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.
  • 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.
Same as current
Complete list of historical versions of study NCT02328469 on ClinicalTrials.gov Archive Site
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Aseptic Meningoencephalitis in Slovenia
Prospective Study of the Etiology, Pathogenesis, Clinical Picture and Outcome of Aseptic Meningitis in Slovenia

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
Not Provided
Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:
Samples of full blood, serum and plasma will be collected and retained in deep freezer for further analyses.
Non-Probability Sample
adult patients with acute aseptic meningitis/meningoencephalitis
Aseptic Meningitis
  • 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.
  • Drug: Acyclovir
    Patients will be treated with intravenous acyclovir 10 mg per kg three times daily for 14 to 21 days.
  • unidentified aseptic meningitis
    Patients with etiologically unidentified aseptic meningitis will be treated with symptomatic therapy and will be asked to complete a questionnaire.
    Interventions:
    • 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.
    Interventions:
    • 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.
    Interventions:
    • 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.
    Interventions:
    • 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.
    Interventions:
    • Drug: symptomatic therapy
    • Other: questionnaire
    • Drug: Acyclovir
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
800
June 2017
June 2017   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Yes
Contact: Daša Stupica, MD, PhD +386 1 5222110 dasa.stupica@kclj.si
Contact: Franc Strle, MD, PhD +386 1 5222610 franc.strle@kclj.si
Slovenia
 
 
NCT02328469
mgt-0614
No
Not Provided
Not Provided
Franc Strle, University Medical Centre Ljubljana
University Medical Centre Ljubljana
  • Slovenian Research Agency
  • University of Ljubljana School of Medicine, Slovenia
  • Harvard University
Study Chair: Franc Strle, MD, PhD UMC Ljubljana
Principal Investigator: Daša Stupica, MD, PhD UMC Ljubljana
University Medical Centre Ljubljana
May 2016