Infections of the Central Nervous System

Withdrawn

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

• Registration Number: NCT03856528
• Lead Sponsor: University Hospital, Basel, Switzerland

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.

Study Timeline

• Study First Submitted: 2019-02-26
• Study First Submitted QC: 2019-02-26
• Study First Posted: 2019-02-27
• Study Start: 2019-03-01
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-14
• Last Update Posted: 2025-02-19

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: 500

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pathologic CT findings	single 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 LP	single 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
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

Secondary Outcome Measures

Name	Time	Method
Glasgow Outcome Score	single 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.
cerebral herniation (number)	single time point assessment during hospital stay (up to 4 weeks)	cerebral herniation as a complication of LP
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.
hematoma (number)	single time point assessment during hospital stay (up to 4 weeks)	hematoma 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
postpuncture headache (number)	single time point assessment during hospital stay (up to 4 weeks)	postpuncture headache as a complication of LP
kind of medication	single time point assessment during hospital stay (up to 4 weeks)	assessment of medication (treatment characteristics ) of patients with suspected and confirmed ME
Death during hospital stay	single time point assessment during hospital stay (up to 4 weeks)	assessment of number of patients with in-hospital death
Return to premorbid functional baseline	single time point assessment during hospital stay (up to 4 weeks)	assessment of number of patients with return to premorbid functional baseline

Trial Locations

Locations (1)

Clinic for Intensive Care Medicine, University Hospital Basel; 🇨🇭 Basel, Switzerland