Clinical trial NCT03856528: Infections of the Central Nervous System
Official title: Infections of the Central Nervous System - an Observational Cohort Study
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Adult Patients With Suspected Meningitis and/or Encephalitis
Keywords: meningitis
encephalitis
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2019-02-27
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_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).

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.

Eligibility criteria: 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).

Primary outcomes:
measure: incidence of patients with suspected and confirmed ME (number)
timeFrame: single time point assessment during hospital stay (up to 4 weeks)
measure: Pathologic CT findings
timeFrame: single time point assessment during hospital stay (up to 4 weeks)
measure: Pathologic CT findings constituting a risk factor for herniation after performance of LP
timeFrame: single time point assessment during hospital stay (up to 4 weeks)
Secondary outcomes:
measure: hematoma (number)
timeFrame: single time point assessment during hospital stay (up to 4 weeks)
measure: Glasgow Outcome Score
timeFrame: single time point assessment during hospital stay (up to 4 weeks)
measure: postpuncture headache (number)
timeFrame: single time point assessment during hospital stay (up to 4 weeks)
measure: cerebral herniation (number)
timeFrame: single time point assessment during hospital stay (up to 4 weeks)
measure: pathological CT findings (number)
timeFrame: single time point assessment at hospitalisation (Day1)
measure: kind of medication
timeFrame: single time point assessment during hospital stay (up to 4 weeks)
measure: Intensive Care Delirium Screening Checklist (ICDSC)
timeFrame: single time point assessment during hospital stay (up to 4 weeks)
measure: Death during hospital stay
timeFrame: single time point assessment during hospital stay (up to 4 weeks)
measure: Return to premorbid functional baseline
timeFrame: single time point assessment during hospital stay (up to 4 weeks)
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Clinic for Intensive Care Medicine, University Hospital Basel
Study officials:
affiliation: Clinic for Intensive Care Medicine, University Hospital Basel
name: Raoul Sutter, PD Dr. med
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.