An observational study in Central Nervous System Infections, Bacterial Meningitis and Viral Meningitis, sponsored by Aalborg University Hospital. Recruiting at 8 sites in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-05-16.
Sponsored by Aalborg University Hospital · Observational
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.
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
38 studies on the registry are indexed under Meningitis, Bacterial; 11 are open to participants now.
This study's planned enrollment of 1,900 is above the median of 555 across 15 observational studies indexed under Meningitis, Bacterial.
Browse Meningitis, Bacterial studies →Aalborg University Hospital is the lead sponsor of 198 studies on the registry; 41 are open to participants now.
Compared within Meningitis, Bacterial, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Central Nervous System Infections. The counts are of registry records indexed under each term, refreshed daily. How we classify →
All patients above 17 years of age are prospectively included in the DASGIB cohort by the principal investigator at each site if they have a clinical presentation suggestive of CNS infection (e.g. any combination of neck stiffness, fever, headache or altered mental status) and either (i) Positive CSF culture or positive bacterial/viral DNA-based analysis for (community-acquired) pathogens in the CSF or (ii) a positive blood culture and CSF leukocytes >10/mL or (iii) CSF leukocytes > 10/mL without any alternative diagnoses more likely to explain the patients' conditions. Exceptions apply for brain abscess, neurosyphilis and neuroborreliosis and exact definitions of included CNS infections are provided below.
We exclude patients with hospital-acquired CNS infections as defined by the Centers for Disease Control and Prevention (Garner et al, Am J Infect Control, 1988), or an implanted neurosurgical device.
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
and
Cerebrospinal fluid leukocytes>10 cells/ml
Patients with viral meningitis with undetermined pathogen have to have:
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:
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
Primary brain abscess inclusion criteria
and
or
or
or
or
Lyme neuroborreliosis inclusion criteria
and
and
Neurosyphilis inclusion criteria - A clinical presentation consistent with neurosyphilis (e.g. 'encephalitis-like symptoms', dementia, ocular or otogenic syphilis)
and either
or
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Prospective observational registration of clinical characteristics and outcome
Also known as: bacterial meningitis, viral meningitis, encephalitis, brain abscess, neuroborreliosis, neurosyphilis
Incidence
Incidence of CNS infections in the adult population (\>17 years of age) in Denmark.
Time frame: One year
Glasgow Outcome Scale score
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
Time frame: One month after end of treatment
Glasgow Outcome Scale score for viral meningitis
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
Time frame: 30 days
Glasgow Outcome Scale score for bacterial meningitis
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
Time frame: 30 days
Glasgow Outcome Scale score for encephalitis
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
Time frame: 30 days
Glasgow Outcome Scale score for neurosyphilis
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
Time frame: 2 weeks
Glasgow Outcome Scale score for neuroborreliosis
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
Time frame: 2 weeks
Glasgow Outcome Scale score for brain abscess
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
Time frame: 8 weeks
Plan to share: Undecided
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