Aseptic Meningoencephalitis in Slovenia

Aseptic Meningitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02328469
• Other study ID #: mgt-0614
• Status: Recruiting
• Start date: June 2014
• Est. completion date: June 2020

Study information

• Verified date: May 2018
• Source: University Medical Centre Ljubljana
• Contact: Daša Stupica, MD, PhD
• Phone: +386 1 5222110
• Email: dasa.stupica[@]kclj.si
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 800
• Est. completion date: June 2020
• Est. primary completion date: June 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aseptic Meningitis
• Meningitis

Intervention

Drug:
• symptomatic therapy
patients will receive symptomatic therapy with antipyretics, analgetics, antiemetics and parenteral hydration: metamizole, paracetamol, thiethylperazine, saline
• 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.

Locations

Country	Name	City	State
Slovenia	Department of Infectious Diseases, University Medical Center Ljubljana, Ljubljana, Slovenia	Ljubljana
Slovenia	UMC Ljubljana, Department of Infectious Diseases	Ljubljana

Sponsors (4)

Lead Sponsor	Collaborator
University Medical Centre Ljubljana	Harvard University, Slovenian Research Agency, University of Ljubljana School of Medicine, Slovenia

Country where clinical trial is conducted

Slovenia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in selected clinical parameters in patients with acute aseptic meningitis/meningoencephalitis	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.	at enrollment and during 12 months follow-up
Primary	Changes in selected laboratory parameters in patients with acute aseptic meningitis/meningoencephalitis	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.	at enrollment and during 12 months follow-up
Primary	Changes in selected microbiologic parameters in patients with acute aseptic meningitis/meningoencephalitis	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.	at enrollment and during 12 months follow-up