Central Nervous System Infections in Denmark

Recruiting

• Conditions: Central Nervous System Infections; Neuroborreliosis; Bacterial Meningitis; Meningitis; Viral Meningitis; Aseptic Meningitis; Brain Abscess; Cerebral Abscess; Encephalitis; Neurosyphilis

• Registration Number: NCT03418441
• Lead Sponsor: Aalborg University Hospital

Brief Summary

The Danish Study Group of Infections of the Brain is a collaboration between all departments of infectious diseases in Denmark. The investigators aim to monitor epidemiological trends in central nervous system (CNS) infections by a prospective registration of clinical characteristics and outcome of all adult (\>17 years of age) patients with community-acquired CNS infections diagnosed and/or treated at departments of infectious diseases in Denmark since 1st of January 2015.

Detailed Description

The investigators include data on diagnosis at admission, symptoms and signs on admission, character and timing of diagnostic work-up and treatment and outcome assessed by the Glasgow Outcome Score (GOS).

Diagnostic work-up and treatment is left at the discretion of the local physician and therefore not standardised

In general any symptoms/deficits should only be listed if they are 'new' to the patient, e.g. a known palsy of the facial nerve should not be listed as a new relevant finding at admission. On the other hand, worsening of a known neurological deficit should be listed under signs in the given instrument (bacterial meningitis, encephalitis, neuroborreliosis etc). Likewise, for outcome only changes in pre-morbid conditions should be listed including place of residence, functional status, neurological deficits etc.

Time of admission is obtained in prioritized order from the ambulance charts or notifications of arrival by secretaries or nurses in the emergency departments. Timing of lumbar puncture and cranial imaging is extracted from the electronic records at the departments of biochemistry or radiology while timing of antibiotic therapy for meningitis is identified in electronic medication systems. Time to lumbar puncture, cranial imaging and antibiotic therapy is calculated as time from arrival at hospital to each of the above events.

Quality control of case enrollment is ensured by ad hoc case-to-case discussions and at study group meetings 2-3 times a year

To ensure completeness of reported CNS infections annual searches of selected International Classification of Diseases version 10 (ICD-10) codes are performed in local administrative databases at each department:

A17 A32.1 A32.7 A39.0 A52.1-52.3 A69.2 (neuroborreliosis) A83 A84 A85 A87 A89 B00.3-00.4 B01.0-01.1 B02.0-02.0 B582 B451 B375 G00 G01 G02 G03 G04 G05 G06 G07

Study Timeline

• Study Start: 2015-01-01
• Study First Submitted: 2018-01-12
• Study First Submitted QC: 2018-01-25
• Study First Posted: 2018-02-01
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-15
• Last Update Posted: 2024-05-16
• Primary Completion: 2030-01-01
• Study Completion: 2030-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1900

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence	One year	Incidence of CNS infections in the adult population (\>17 years of age) in Denmark.

Secondary Outcome Measures

Name	Time	Method
Glasgow Outcome Scale score for encephalitis	30 days	A five tier assessment of functional status, 1=Death, 2=vegetative state, 3=dependency on others for daily activities, 4=some sequelae but able to live independently, 5= No or only minor sequelae
Glasgow Outcome Scale score for neuroborreliosis	2 weeks	A five tier assessment of functional status, 1=Death, 2=vegetative state, 3=dependency on others for daily activities, 4=some sequelae but able to live independently, 5= No or only minor sequelae
Glasgow Outcome Scale score for brain abscess	8 weeks	A five tier assessment of functional status, 1=Death, 2=vegetative state, 3=dependency on others for daily activities, 4=some sequelae but able to live independently, 5= No or only minor sequelae
Glasgow Outcome Scale score	One month after end of treatment	A five tier assessment of functional status, 1=Death, 2=vegetative state, 3=dependency on others for daily activities, 4=some sequelae but able to live independently, 5= No or only minor sequelae
Glasgow Outcome Scale score for viral meningitis	30 days	A five tier assessment of functional status, 1=Death, 2=vegetative state, 3=dependency on others for daily activities, 4=some sequelae but able to live independently, 5= No or only minor sequelae
Glasgow Outcome Scale score for bacterial meningitis	30 days	A five tier assessment of functional status, 1=Death, 2=vegetative state, 3=dependency on others for daily activities, 4=some sequelae but able to live independently, 5= No or only minor sequelae
Glasgow Outcome Scale score for neurosyphilis	2 weeks	A five tier assessment of functional status, 1=Death, 2=vegetative state, 3=dependency on others for daily activities, 4=some sequelae but able to live independently, 5= No or only minor sequelae

Trial Locations

Locations (8)

Herlev-Gentofte Hospital; 🇩🇰 Copenhagen, Denmark

Department of Infectious Diseases, Aalborg University Hospital; 🇩🇰 Aalborg, Denmark

Department of Infectious Diseases, Aarhus University Hospital Skejby; 🇩🇰 Aarhus, Denmark

Department of Pulmonary and Infectious Diseases, Nordsjællands Hospital Hillerød; 🇩🇰 Hillerød, Denmark

Department of Infectious Diseases, Hvidovre Hospital; 🇩🇰 Hvidovre, Denmark

Department of Infectious Diseases, Odense University Hospital; 🇩🇰 Odense, Denmark

Department of Pulmonary and Infectious Diseases, Sjællands University Hospital Roskilde; 🇩🇰 Roskilde, Denmark

Department of Infectious Diseases, Rigshospitalet; 🇩🇰 Copenhagen, Denmark