NCT03856528

Brief 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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Mar 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 26, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 27, 2019

Completed
2 days until next milestone

Study Start

First participant enrolled

March 1, 2019

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

February 19, 2025

Status Verified

February 1, 2025

Enrollment Period

5.8 years

First QC Date

February 26, 2019

Last Update Submit

February 14, 2025

Conditions

Keywords

meningitisencephalitis

Outcome Measures

Primary Outcomes (3)

  • incidence of patients with suspected and confirmed ME (number)

    assessment of number of patients with suspected and confirmed ME

    single time point assessment during hospital stay (up to 4 weeks)

  • Pathologic CT findings

    assessment of number of patients with pathologic CT findings

    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

    single time point assessment during hospital stay (up to 4 weeks)

Secondary Outcomes (9)

  • hematoma (number)

    single time point assessment during hospital stay (up to 4 weeks)

  • Glasgow Outcome Score

    single time point assessment during hospital stay (up to 4 weeks)

  • postpuncture headache (number)

    single time point assessment during hospital stay (up to 4 weeks)

  • cerebral herniation (number)

    single time point assessment during hospital stay (up to 4 weeks)

  • pathological CT findings (number)

    single time point assessment at hospitalisation (Day1)

  • +4 more secondary outcomes

Interventions

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)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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).

You may qualify if:

  • 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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinic for Intensive Care Medicine, University Hospital Basel

Basel, 4031, Switzerland

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

MeningitisEncephalitis

Condition Hierarchy (Ancestors)

Neuroinflammatory DiseasesNervous System DiseasesBrain DiseasesCentral Nervous System Diseases

Study Officials

  • Raoul Sutter, PD Dr. med

    Clinic for Intensive Care Medicine, University Hospital Basel

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 26, 2019

First Posted

February 27, 2019

Study Start

March 1, 2019

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

February 19, 2025

Record last verified: 2025-02

Locations