Aseptic Meningitis
Conditions
Keywords
aseptic meningitis, tick-borne encephalitis, Lyme neuroborreliosis, inflammation, outcome
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
Interventions
patients will receive symptomatic therapy with antipyretics, analgetics, antiemetics and parenteral hydration: metamizole, paracetamol, thiethylperazine, saline
DRUGCeftriaxone 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
OTHERquestionnaire
Control subjects will be asked to answer a questionnaire asking about the presence and frequency of nonspecific symptoms.
DRUGAcyclovir
Patients will be treated with intravenous acyclovir 10 mg per kg three times daily for 14 to 21 days.
Sponsors
Slovenian Research Agency
University of Ljubljana School of Medicine, Slovenia
Harvard University
University Medical Centre Ljubljana
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Slovenia
Contacts
Primary ContactDaša Stupica, MD, PhD
Backup ContactFranc Strle, MD, PhD
Outcome results
None listed