Infections of the Central Nervous System

February 14, 2025 updated by: University Hospital, Basel, Switzerland

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

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Sarah Tschudin Sutter, PD Dr. med

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
incidence of patients with suspected and confirmed ME (number)
Time Frame: single time point assessment during hospital stay (up to 4 weeks)
assessment of number of patients with suspected and confirmed ME
single time point assessment during hospital stay (up to 4 weeks)
Pathologic CT findings
Time Frame: single time point assessment during hospital stay (up to 4 weeks)
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
Time Frame: 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
single time point assessment during hospital stay (up to 4 weeks)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
hematoma (number)
Time Frame: single time point assessment during hospital stay (up to 4 weeks)
hematoma as a complication of LP
single time point assessment during hospital stay (up to 4 weeks)
Glasgow Outcome Score
Time Frame: 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.
single time point assessment during hospital stay (up to 4 weeks)
postpuncture headache (number)
Time Frame: single time point assessment during hospital stay (up to 4 weeks)
postpuncture headache as a complication of LP
single time point assessment during hospital stay (up to 4 weeks)
cerebral herniation (number)
Time Frame: single time point assessment during hospital stay (up to 4 weeks)
cerebral herniation as a complication of LP
single time point assessment during hospital stay (up to 4 weeks)
pathological CT findings (number)
Time Frame: 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
single time point assessment at hospitalisation (Day1)
kind of medication
Time Frame: single time point assessment during hospital stay (up to 4 weeks)
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)
Time Frame: 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.
single time point assessment during hospital stay (up to 4 weeks)
Death during hospital stay
Time Frame: single time point assessment during hospital stay (up to 4 weeks)
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
Time Frame: single time point assessment during hospital stay (up to 4 weeks)
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Basel, Switzerland

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Raoul Sutter, PD Dr. med, Clinic for Intensive Care Medicine, University Hospital Basel

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2019

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 26, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 26, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 27, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 14, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings