Infections of the Central Nervous System

Adult Patients With Suspected Meningitis and/or Encephalitis Clinical Trial

Official title:

Infections of the Central Nervous System - an Observational Cohort Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03856528
• Other study ID #: 2016-01244; me19Sutter2
• Status: Recruiting
• Start date: March 1, 2019
• Est. completion date: February 1, 2025

Study information

• Verified date: January 2024
• Source: University Hospital, Basel, Switzerland
• Contact: Raoul Sutter, PD Dr. med
• Phone: +41 61 265 25 25
• Email: Raoul.Sutter[@]usb.ch
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: February 1, 2025
• Est. primary completion date: February 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Adult Patients With Suspected Meningitis and/or Encephalitis
• Encephalitis
• Meningitis

Intervention

Other:
• collection of patient data
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)

Locations

Country	Name	City	State
Switzerland	Clinic for Intensive Care Medicine, University Hospital Basel	Basel

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	Pathologic CT findings	assessment of number of patients with pathologic CT findings	single time point assessment during hospital stay (up to 4 weeks)
Primary	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	hematoma (number)	hematoma as a complication of LP	single time point assessment during hospital stay (up to 4 weeks)
Secondary	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)
Secondary	postpuncture headache (number)	postpuncture headache as a complication of LP	single time point assessment during hospital stay (up to 4 weeks)
Secondary	cerebral herniation (number)	cerebral herniation as a complication of LP	single time point assessment during hospital stay (up to 4 weeks)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	Death during hospital stay	assessment of number of patients with in-hospital death	single time point assessment during hospital stay (up to 4 weeks)
Secondary	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)