Aseptic MeningitisNCT02328469
Aseptic Meningoencephalitis in Slovenia
An observational study of Aseptic Meningitis, run by University Medical Centre Ljubljana at 2 sites in Slovenia.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aseptic Meningitis
- What is being tested?
- symptomatic therapy, Ceftriaxone or Doxycycline and questionnaire
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 800 participants
- Where
- 2 sitesSlovenia
- Study dates
- Jun 2014to Jun 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: adult patients with acute aseptic meningitis/meningoencephalitis
Who may be able to join
- 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)
Who cannot join
- younger than 18 years
- pregnant women
Trial locations and contacts
2 sites in 1 country.
Slovenia2 sites, 2 recruiting
- Recruiting
Department of Infectious Diseases, University Medical Center Ljubljana, Ljubljana, Slovenia
Ljubljana, 1525
Daša Stupica, MD, +386 1 522 2110, dasa.stupica@kclj.si
Franc Strle, MD, +386 1 5222610, franc.strle@kclj.si
- Recruiting
UMC Ljubljana, Department of Infectious Diseases
Ljubljana, 1525
Daša Stupica, MD, PhD, +386 1 522 2110, dasa.stupica@kclj.si
Franc Strle, MD, PhD, +386 1 522 2610, franc.strle@kclj.si
About this study
Official title: 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
- Conditions
- Aseptic Meningitis
- Being tested
- symptomatic therapy, Ceftriaxone or Doxycycline, questionnaire, Acyclovir
- Keywords
- aseptic meningitis, tick-borne encephalitis, Lyme neuroborreliosis, inflammation, outcome
- Medical subject headings
- Meningitis, Aseptic, Encephalitis, Tick-Borne, Lyme Neuroborreliosis, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
symptomatic therapyDrug
patients will receive symptomatic therapy with antipyretics, analgetics, antiemetics and parenteral hydration: metamizole, paracetamol, thiethylperazine, saline
Ceftriaxone or DoxycyclineDrug
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
questionnaireOther
Control subjects will be asked to answer a questionnaire asking about the presence and frequency of nonspecific symptoms.
AcyclovirDrug
Patients will be treated with intravenous acyclovir 10 mg per kg three times daily for 14 to 21 days.
| Study group | Role | What they receive |
|---|---|---|
| unidentified aseptic meningitis | Patients with etiologically unidentified aseptic meningitis will be treated with symptomatic therapy and will be asked to complete a questionnaire. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: Drug: symptomatic therapy; Other: questionnaire; Drug: Acyclovir |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at enrollment and during 12 months follow-up
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.
Measured: at enrollment and during 12 months follow-up
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.
Measured: at enrollment and during 12 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2014 (estimated)
- Study startJun 2014
- Primary completionJun 2020 (estimated)
- Study completionJun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aseptic MeningitisStudies of the same condition, open and under way.
- More trials run by University Medical Centre LjubljanaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Centre Ljubljana
- Sponsor type
- University, hospital or other
- Collaborators
- Slovenian Research Agency, University of Ljubljana School of Medicine, Slovenia, Harvard University
- Responsible party
- Principal investigator, Franc Strle, University Medical Centre Ljubljana
- Investigators
- Franc Strle, MD, PhD, Study chair, UMC LjubljanaDaša Stupica, MD, PhD, Principal investigator, UMC Ljubljana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02328469
- Sponsor's protocol ID
- mgt-0614
- Status last verified
- May 2018
- First submitted
- 27 May 2014
- Last updated
- 4 May 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study of the Etiology, Pathogenesis, Clinical Picture and Outcome of Aseptic Meningitis in Slovenia
- ClinicalTrials.gov ID
- NCT02328469
- Acronym / sponsor ID
- mgt-0614
- Conditions
- Aseptic Meningitis
- Keywords
- aseptic meningitis, tick-borne encephalitis, Lyme neuroborreliosis, inflammation, outcome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- University Medical Centre LjubljanaUniversity, hospital or other
- Collaborators
- Slovenian Research Agency, University of Ljubljana School of Medicine, Slovenia, Harvard University
- Study start
- Jun 2014
- Primary completion
- Jun 2020 (estimated)
- Study completion
- Jun 2020 (estimated)
- First posted
- 31 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| unidentified aseptic meningitis | – | Drug: symptomatic therapy, Other: questionnairePatients with etiologically unidentified aseptic meningitis will be treated with symptomatic therapy and will be asked to complete a questionnaire. |
| tick-borne encephalitis | – | Drug: symptomatic therapy, Other: questionnairePatient 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. |
| Lyme neuroborreliosis | – | Drug: symptomatic therapy, Drug: Ceftriaxone or Doxycycline, Other: questionnairePatients 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. |
| healthy controls | – | Drug: symptomatic therapy, Other: questionnairePatients 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. |
| identified aseptic meningitis | – | Drug: symptomatic therapy, Other: questionnaire, Drug: AcyclovirPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- adult patients with acute aseptic meningitis/meningoencephalitis
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (2 listed)
- younger than 18 years
- pregnant women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| symptomatic therapypatients will receive symptomatic therapy with antipyretics, analgetics, antiemetics and parenteral hydration: metamizole, paracetamol, thiethylperazine, saline | Drug | Lyme neuroborreliosis, healthy controls, identified aseptic meningitis, tick-borne encephalitis, unidentified aseptic meningitis |
| Ceftriaxone or Doxycyclinebeside 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 | Drug | Lyme neuroborreliosis |
| questionnaireControl subjects will be asked to answer a questionnaire asking about the presence and frequency of nonspecific symptoms. | Other | Lyme neuroborreliosis, healthy controls, identified aseptic meningitis, tick-borne encephalitis, unidentified aseptic meningitis |
| AcyclovirPatients will be treated with intravenous acyclovir 10 mg per kg three times daily for 14 to 21 days. | Drug | identified aseptic meningitis |
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Franc Strle, MD, PhD study chair
UMC Ljubljana
Daša Stupica, MD, PhD principal investigator
UMC Ljubljana
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aseptic Meningitis, run by University Medical Centre Ljubljana at 2 sites in Slovenia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Slovenia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Daša Stupica, MD, PhD (+386 1 5222110, dasa.stupica@kclj.si), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2018.