Clinical Trial: Aseptic Meningoencephalitis in Slovenia

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

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

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

Detailed Summary:
Sponsor: University Medical Centre Ljubljana

Current Primary Outcome:

  • 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: University Medical Centre Ljubljana

Dates:
Date Received: May 27, 2014
Date Started: June 2014
Date Completion: June 2017
Last Updated: May 11, 2016
Last Verified: May 2016