Infections of the Central Nervous System

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.

Study Overview

• Status: Withdrawn
• Conditions: Adult Patients With Suspected Meningitis and/or Encephalitis
• Intervention / Treatment: Other: collection of patient data

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.

• Study Type: Observational

Contacts and Locations

Study Locations

• Switzerland
  • Basel, Switzerland, 4031
    • Clinic for Intensive Care Medicine, University Hospital Basel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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).

Description

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).

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
hematoma (number)	hematoma as a complication of LP	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.	single time point assessment during hospital stay (up to 4 weeks)
postpuncture headache (number)	postpuncture headache as a complication of LP	single time point assessment during hospital stay (up to 4 weeks)
cerebral herniation (number)	cerebral herniation as a complication of LP	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	single time point assessment at hospitalisation (Day1)
kind of medication	assessment of medication (treatment characteristics ) of patients with suspected and confirmed ME	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.	single time point assessment during hospital stay (up to 4 weeks)
Death during hospital stay	assessment of number of patients with in-hospital death	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	single time point assessment during hospital stay (up to 4 weeks)

Collaborators and Investigators

• Sponsor: University Hospital, Basel, Switzerland
• Investigators: Principal Investigator: Raoul Sutter, PD Dr. med, Clinic for Intensive Care Medicine, University Hospital Basel

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2019
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: February 26, 2019
• First Submitted That Met QC Criteria: February 26, 2019
• First Posted (Actual): February 27, 2019

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 14, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: meningitis; encephalitis
• Additional Relevant MeSH Terms: Neuroinflammatory Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Meningitis; Encephalitis
• Other Study ID Numbers: 2016-01244; me19Sutter2

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No