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Infections of the Central Nervous System

Infections of the Central Nervous System - an Observational Cohort Study

Status
Withdrawn
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03856528
Enrollment
0
Registered
2019-02-27
Start date
2019-03-01
Completion date
2024-12-31
Last updated
2025-02-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adult Patients With Suspected Meningitis and/or Encephalitis

Keywords

meningitis, encephalitis

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.

Detailed description

The specific aims of the study include: 1. To assess the incidence, the diagnostic workup, and the treatment characteristics of patients with suspected and confirmed ME. 2. To examine clinical differences between patients with initially suspected and confirmed infectious Meningitis (ME) versus those with suspected but not confirmed infectious ME. 3. To evaluate potentially prognostic factors for pathological CT findings (especially expanding cerebral mass lesions) in patients with suspected infectious ME. 4. To identify a specific group of patients that benefit from cranial CT prior to LP. 5. To examine possible complications (e.g., hematoma, postpuncture headache, cerebral herniation, …) of lumbal punction (LP) and their correlations to pathologic signs on cranial CT. 6. To compare the outcome between patients with suspected infectious ME and cranial CT prior to LP versus patients without prior cranial CT.

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)

Sponsors

University Hospital, Basel, Switzerland
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* 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).

Design outcomes

Primary

MeasureTime frameDescription
incidence of patients with suspected and confirmed ME (number)single time point assessment during hospital stay (up to 4 weeks)assessment of number of patients with suspected and confirmed ME
Pathologic CT findingssingle 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 LPsingle 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

Secondary

MeasureTime frameDescription
cerebral herniation (number)single time point assessment during hospital stay (up to 4 weeks)cerebral herniation as a complication of LP
pathological CT findings (number)single time point assessment at hospitalisation (Day1)number and evaluation of pathological CT findings (especially expanding cerebral mass lesions) in patients with suspected infectious ME
kind of medicationsingle time point assessment during hospital stay (up to 4 weeks)assessment of medication (treatment characteristics ) of patients with suspected and confirmed ME
hematoma (number)single time point assessment during hospital stay (up to 4 weeks)hematoma as a complication of LP
Death during hospital staysingle time point assessment during hospital stay (up to 4 weeks)assessment of number of patients with in-hospital death
Return to premorbid functional baselinesingle time point assessment during hospital stay (up to 4 weeks)assessment of number of patients with return to premorbid functional baseline
Intensive Care Delirium Screening Checklist (ICDSC)single time point assessment during hospital stay (up to 4 weeks)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.
Glasgow Outcome Scoresingle time point assessment during hospital stay (up to 4 weeks)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.
postpuncture headache (number)single time point assessment during hospital stay (up to 4 weeks)postpuncture headache as a complication of LP

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 18, 2026