Infections of the Central Nervous System

Study Overview
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Brief Summary
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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
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The specific aims of the study include: To assess the incidence, the diagnostic workup, and the treatment characteristics of patients with suspected and confirmed ME. To examine clinical differences between patients with initially suspected and confirmed infectious Meningitis (ME) versus those with suspected but not confirmed infectious ME. To evaluate potentially prognostic factors for pathological CT findings (especially expanding cerebral mass lesions) in patients with suspected infectious ME. To identify a specific group of patients that benefit from cranial CT prior to LP. To examine possible complications (e.g., hematoma, postpuncture headache, cerebral herniation, …) of lumbal punction (LP) and their correlations to pathologic signs on cranial CT. To compare the outcome between patients with suspected infectious ME and cranial CT prior to LP versus patients without prior cranial CT.

Official Title
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Infections of the Central Nervous System - an Observational Cohort Study

Conditions
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Adult Patients With Suspected Meningitis and/or Encephalitis

Intervention / Treatment
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* Other: collection of patient data


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|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)|

What is the study measuring?
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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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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meningitis, encephalitis