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Central Nervous System Infections in Denmark

Danish Study Group of Infections of the Brain: A Nationwide Prospective Observational Cohort Study of All Central Nervous System Infections in Adults at Departments of Infectious Diseases in Denmark

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03418441
Acronym
DASGIB
Enrollment
1900
Registered
2018-02-01
Start date
2015-01-01
Completion date
2030-01-01
Last updated
2024-05-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aseptic Meningitis, Bacterial Meningitis, Brain Abscess, Central Nervous System Infections, Cerebral Abscess, Encephalitis, Lyme Disease, Meningitis, Neuroborreliosis, Neurosyphilis, Tertiary Syphilis, Viral Meningitis

Keywords

Nationwide prospective observational cohort study, Epidemiology, Central Nervous System Infections, Meningitis, Encephalitis, Brain abscess, Lyme disease, Neuroborreliosis, Neurosyphilis, Tertiary syphilis

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

Interventions

OTHERCommunity-acquired CNS infections

Prospective observational registration of clinical characteristics and outcome

Sponsors

Danish Study Group of Infections of the Brain
CollaboratorOTHER
Aalborg University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Definitions of central nervous system infections: For all cases with unproven aetiologies no alternative diagnosis than CNS infection is thought more likely after completed multidisciplinary diagnostic work-up. Viral meningitis inclusion criteria \- All patients have to have a clinical presentation consistent with non-bacterial meningitis (e.g. headache, neck stiffness, photo- or phonophobia, fever) and Cerebrospinal fluid leukocytes\>10 cells/ml Patients with viral meningitis with undetermined pathogen have to have: * CSF leukocytes\> 10/mL and no other more probable diagnosis assessed by the local investigator. In case of doubt, patients are discussed with the DASGIB secretary and chair or at meetings. Bacterial meningitis inclusion criteria - All patients have to have a clinical presentation consistent with bacterial meningitis (e.g. headache, neck stiffness, fever, altered mental status) and Proven bacterial aetiology (CSF or blood culture/DNA based technology or antigen tests) Patients with bacterial meningitis in whom the bacteria cannot not be cultured or identified by DNA-based technologies have to have: \- CSF leukocytes\> 10/mL and no other more probable diagnosis assessed by the local investigator. In case of doubt, patients are discussed with the DASGIB secretary and chair or at meetings. Encephalitis inclusion criteria - All patients have to have a clinical presentation consistent with encephalitis (e.g. headache, fever, focal neurological deficit, altered mental status \>24 hours) as defined by the International Encephalitis Consortium (Venkatesan A et al., Clin Infect Dis 2013; doi:10.1093/cid/cit458.). Encephalitis

Exclusion criteria

\- We exclude cases of proven or suspected autoimmune encephalitis. Primary brain abscess inclusion criteria \- All patient have a clinical presentation consistent with brain abscess (e.g. headache, focal neurological deficit, mass lesion on cranial imaging) and \- Proven microbiological aetiology by culture/DNA-based technology from pus from brain abscess or blood or CSF or \- Aspiration of pus from the brain abscess or \- Response to antimicrobial treatment or \- Tumour ruled out or \- Tumour thought less probable than abscess on MRI using diffusion weighted imaging (DWI) and apparent diffusion coefficient (ADC) sequences. Lyme neuroborreliosis inclusion criteria \- A clinical presentation consistent with neuroborreliosis (e.g. radiculopathy) and \- CSF pleocytosis\>10 leukocytes/mL and \- Positive intrathecal B.burgdorferi antibody production index. Neurosyphilis inclusion criteria - A clinical presentation consistent with neurosyphilis (e.g. 'encephalitis-like symptoms', dementia, ocular or otogenic syphilis) and either \- Positive syphilis serology in serum combined with CSF leukocytes\>10/mL or \- CSF syphilis antibodies.

Design outcomes

Primary

MeasureTime frameDescription
IncidenceOne yearIncidence of CNS infections in the adult population (\>17 years of age) in Denmark.

Secondary

MeasureTime frameDescription
Glasgow Outcome Scale score for viral meningitis30 daysA 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 meningitis30 daysA 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 encephalitis30 daysA 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 scoreOne month after end of treatmentA 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 neuroborreliosis2 weeksA 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 abscess8 weeksA 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 neurosyphilis2 weeksA 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

Countries

Denmark

Contacts

Primary ContactJacob Bodilsen, MD
jacob.bodilsen@rn.dk+45 99663920
Backup ContactHenrik Nielsen, Professor
henrik.nielsen@rn.dk+45 99663920

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026