Adult Patients With Suspected Meningitis and/or EncephalitisNCT03856528
Infections of the Central Nervous System
An observational study of Adult Patients With Suspected Meningitis and/or Encephalitis, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
This study is to describe the incidence of infectious meningitis and/or encephalitis, and to analyze clinical, diagnostic and treatment characteristics of patients with suspected (and subsequently verified and not verified) infection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adult Patients With Suspected Meningitis and/or Encephalitis
- What is being tested?
- collection of patient data
- How many people
- 0 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Mar 2019to 31 Dec 2024
- 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
- No healthy volunteers
- Adult, Older adult
Study population: All patients admitted to the University Hospital Basel with suspected or confirmed infectious meningitis/encephalitis over a 10-year period (from January 2006 to December 2021).
Who may be able to join
- All patients aged ≥18 years admitted to the University Hospital Basel with confirmed infectious meningitis and/or encephalitis as principal and/or secondary diagnosis from January 2006 to December 2021 with or without cranial CT prior to LP
- All patients aged ≥18 years admitted to the University Hospital Basel over the same time period with suspected infectious meningitis and/or encephalitis as principal and/or secondary diagnosis with or without cranial CT
Who cannot join
- Patients without suspected infectious meningitis and/or encephalitis.
- Patients with the diagnosis of meningitis/encephalitis confirmed prior to hospital admission
- Patients who have refused "General Consent" (i.e., written agreement of patients which allows the further use of their collected medical data for research purposes in encoded form).
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Clinic for Intensive Care Medicine, University Hospital Basel
Basel, 4031
About this study
Official title: Infections of the Central Nervous System - an Observational Cohort Study
This study is to describe the incidence of infectious meningitis and/or encephalitis, and to analyze clinical, diagnostic and treatment characteristics of patients with suspected (and subsequently verified and not verified) infection.
Read the detailed description
The specific aims of the study include:
- To assess the incidence, the diagnostic workup, and the treatment characteristics of patients with suspected and confirmed ME.
- To examine clinical differences between patients with initially suspected and confirmed infectious Meningitis (ME) versus those with suspected but not confirmed infectious ME.
- To evaluate potentially prognostic factors for pathological CT findings (especially expanding cerebral mass lesions) in patients with suspected infectious ME.
- To identify a specific group of patients that benefit from cranial CT prior to LP.
- To examine possible complications (e.g., hematoma, postpuncture headache, cerebral herniation, …) of lumbal punction (LP) and their correlations to pathologic signs on cranial CT.
- To compare the outcome between patients with suspected infectious ME and cranial CT prior to LP versus patients without prior cranial CT.
- Being tested
- collection of patient data
- Keywords
- meningitis, encephalitis
- Medical subject headings
- Meningitis, Encephalitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
collection of patient dataOther
Patient data will be obtained using digital patients records systems. The following data will be assessed: Demographics and baseline patient characteristics (e.g., gender, age, hospital admission and discharge dates), diagnoses, comorbidities (history of meningitis and/or encephalitis, epileptic disorders, remote stroke, remote intracranial bleeding, remote autoimmune disease, neurodegenerative disorders), laboratory features (blood cultures, lumbar puncture), features of neuroimaging (e.g., time admission-to-CT), therapeutic features (incl. time admission-to-treatment), Patients' outcome measures (Glasgow Outcome Score)
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of patients with suspected and confirmed ME (number)
assessment of number of patients with suspected and confirmed ME
Measured: single time point assessment during hospital stay (up to 4 weeks)
Pathologic CT findings
assessment of number of patients with pathologic CT findings
Measured: single time point assessment during hospital stay (up to 4 weeks)
Pathologic CT findings constituting a risk factor for herniation after performance of LP
assessment of number of patients with pathologic CT findings constituting a risk factor for herniation after performance of LP
Measured: single time point assessment during hospital stay (up to 4 weeks)
Secondary outcomes (9)
hematoma (number)
hematoma as a complication of LP
Measured: single time point assessment during hospital stay (up to 4 weeks)
Glasgow Outcome Score
scale of patients with brain injuries that groups victims by the objective degree of recovery.The scale consists of five ordinal outcome categories: good recovery (able to live independently, able to return to work or school), moderate disability (able to live independently, unable to return to work or school), severe disability (able to follow commands, unable to live independently), persistent vegetative state (unable to interact with the environment, unresponsive), and death.
Measured: single time point assessment during hospital stay (up to 4 weeks)
postpuncture headache (number)
postpuncture headache as a complication of LP
Measured: single time point assessment during hospital stay (up to 4 weeks)
cerebral herniation (number)
cerebral herniation as a complication of LP
Measured: single time point assessment during hospital stay (up to 4 weeks)
pathological CT findings (number)
number and evaluation of pathological CT findings (especially expanding cerebral mass lesions) in patients with suspected infectious ME
Measured: single time point assessment at hospitalisation (Day1)
kind of medication
assessment of medication (treatment characteristics ) of patients with suspected and confirmed ME
Measured: single time point assessment during hospital stay (up to 4 weeks)
Intensive Care Delirium Screening Checklist (ICDSC)
The ICDSC is a screening instrument including eight items specifically designed for the intensive care setting with two points: absent or present. The items include the assessment of: (1) consciousness (comatose, soporose, awake, or hypervigilant); (2) orientation; (3) hallucinations or delusions; (4) psychomotor activity; (5) inappropriate speech or mood; (6) attentiveness; (7) sleep-wake cycle disturbances; and (8) fluctuation of symptomatology. The maximum score is eight; scores of ≥4 indicate the presence of Delirium.
Measured: single time point assessment during hospital stay (up to 4 weeks)
Death during hospital stay
assessment of number of patients with in-hospital death
Measured: single time point assessment during hospital stay (up to 4 weeks)
Return to premorbid functional baseline
assessment of number of patients with return to premorbid functional baseline
Measured: single time point assessment during hospital stay (up to 4 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2019
- Study start1 Mar 2019
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Why it stopped: due to personal changes
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Adult Patients With Suspected Meningitis and/or EncephalitisStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Raoul Sutter, PD Dr. med, Principal investigator, Clinic for Intensive Care Medicine, University Hospital Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03856528
- Sponsor's protocol ID
- 2016-01244; me19Sutter2
- Other IDs
- 2016
- Status last verified
- Feb 2025
- First submitted
- 26 Feb 2019
- Last updated
- 19 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Dittrich T, Marsch S, Egli A, Ruegg S, De Marchis GM, Tschudin-Sutter S, Sutter R. Predictors of infectious meningitis or encephalitis: the yield of cerebrospinal fluid in a cross-sectional study. BMC Infect Dis. 2020 Apr 23;20(1):304. doi: 10.1186/s12879-020-05022-6.
PubMed 32326881
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Infections of the Central Nervous System - an Observational Cohort Study
- ClinicalTrials.gov ID
- NCT03856528
- Acronym / sponsor ID
- 2016-01244; me19Sutter2
- Keywords
- meningitis, encephalitis
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: due to personal changes
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 27 Feb 2019 (actual)
- 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.
This study is to describe the incidence of infectious meningitis and/or encephalitis, and to analyze clinical, diagnostic and treatment characteristics of patients with suspected (and subsequently verified and not verified) infection.
Detailed description
The specific aims of the study include:
- To assess the incidence, the diagnostic workup, and the treatment characteristics of patients with suspected and confirmed ME.
- To examine clinical differences between patients with initially suspected and confirmed infectious Meningitis (ME) versus those with suspected but not confirmed infectious ME.
- To evaluate potentially prognostic factors for pathological CT findings (especially expanding cerebral mass lesions) in patients with suspected infectious ME.
- To identify a specific group of patients that benefit from cranial CT prior to LP.
- To examine possible complications (e.g., hematoma, postpuncture headache, cerebral herniation, …) of lumbal punction (LP) and their correlations to pathologic signs on cranial CT.
- To compare the outcome between patients with suspected infectious ME and cranial CT prior to LP versus patients without prior cranial CT.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients admitted to the University Hospital Basel with suspected or confirmed infectious meningitis/encephalitis over a 10-year period (from January 2006 to December 2021).
Key inclusion criteria (2 listed)
- All patients aged ≥18 years admitted to the University Hospital Basel with confirmed infectious meningitis and/or encephalitis as principal and/or secondary diagnosis from January 2006 to December 2021 with or without cranial CT prior to LP
- All patients aged ≥18 years admitted to the University Hospital Basel over the same time period with suspected infectious meningitis and/or encephalitis as principal and/or secondary diagnosis with or without cranial CT
Key exclusion criteria (3 listed)
- Patients without suspected infectious meningitis and/or encephalitis.
- Patients with the diagnosis of meningitis/encephalitis confirmed prior to hospital admission
- Patients who have refused "General Consent" (i.e., written agreement of patients which allows the further use of their collected medical data for research purposes in encoded form).
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 |
|---|---|---|
| collection of patient dataPatient data will be obtained using digital patients records systems. The following data will be assessed: Demographics and baseline patient characteristics (e.g., gender, age, hospital admission and discharge dates), diagnoses, comorbidities (history of meningitis and/or encephalitis, epileptic disorders, remote stroke, remote intracranial bleeding, remote autoimmune disease, neurodegenerative disorders), laboratory features (blood cultures, lumbar puncture), features of neuroimaging (e.g., time admission-to-CT), therapeutic features (incl. time admission-to-treatment), Patients' outcome measures (Glasgow Outcome Score) | Other | – |
Primary outcome
incidence of patients with suspected and confirmed ME (number)
Time frame: single time point assessment during hospital stay (up to 4 weeks)
assessment of number of patients with suspected and confirmed ME
Pathologic CT findings
Time frame: single time point assessment during hospital stay (up to 4 weeks)
assessment of number of patients with pathologic CT findings
Pathologic CT findings constituting a risk factor for herniation after performance of LP
Time frame: single time point assessment during hospital stay (up to 4 weeks)
assessment of number of patients with pathologic CT findings constituting a risk factor for herniation after performance of LP
9 secondary outcomes
hematoma (number)
Time frame: single time point assessment during hospital stay (up to 4 weeks)
Glasgow Outcome Score
Time frame: single time point assessment during hospital stay (up to 4 weeks)
postpuncture headache (number)
Time frame: single time point assessment during hospital stay (up to 4 weeks)
cerebral herniation (number)
Time frame: single time point assessment during hospital stay (up to 4 weeks)
pathological CT findings (number)
Time frame: single time point assessment at hospitalisation (Day1)
kind of medication
Time frame: single time point assessment during hospital stay (up to 4 weeks)
Intensive Care Delirium Screening Checklist (ICDSC)
Time frame: single time point assessment during hospital stay (up to 4 weeks)
Death during hospital stay
Time frame: single time point assessment during hospital stay (up to 4 weeks)
Return to premorbid functional baseline
Time frame: single time point assessment during hospital stay (up to 4 weeks)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2025.
- Derived from this study: PubMed 32326881Dittrich T, Marsch S, Egli A, Ruegg S, De Marchis GM, Tschudin-Sutter S, Sutter R. Predictors of infectious meningitis or encephalitis: the yield of cerebrospinal fluid in a cross-sectional study. BMC Infect Dis. 2020 Apr 23;20(1):304. doi: 10.1186/s12879-020-05022-6.
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.
Raoul Sutter, PD Dr. med principal investigator
Clinic for Intensive Care Medicine, University Hospital Basel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adult Patients With Suspected Meningitis and/or Encephalitis, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
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 2 inclusion and 3 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: withdrawn, as of the sponsor's last update on 19 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of patients with suspected and confirmed ME (number) (time frame: single time point assessment during hospital stay (up to 4 weeks)). 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?
On the ClinicalTrials.gov record for NCT03856528, which also lists 1 linked publication.
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 19 Feb 2025; AzTrials last refreshed its copy on 6 Nov 2026.