Actively Recruiting
Danish Study Group of Infections of the Brain: Nationwide Observational Study of Adult Central Nervous System Infections in Denmark
Led by Aalborg University Hospital · Updated on 2024-05-16
1900
Participants Needed
8
Research Sites
N/A
Total Duration
On this page
Sponsors
A
Aalborg University Hospital
Lead Sponsor
D
Danish Study Group of Infections of the Brain
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are conducting a nationwide observational study in Denmark to track and understand infections of the central nervous system (CNS) among adults aged 18 years and older. This study systematically registers clinical characteristics and outcomes of all community-acquired CNS infections diagnosed or treated at infectious disease departments across the country since January 1, 2015. The aim is to monitor trends in infections such as bacterial meningitis, viral meningitis, encephalitis, brain abscess, neuroborreliosis, and neurosyphilis, among others. The study involves collecting detailed information on diagnosis at admission, symptoms, timing and type of diagnostic tests like lumbar puncture and cranial imaging, and treatments given. These treatments and diagnostic procedures are determined by local physicians and are not standardized across sites. The study ensures data quality through regular case reviews and annual checks of hospital records using specific diagnosis codes to identify CNS infection cases. Participants are monitored for outcomes using the Glasgow Outcome Scale at various time points depending on the infection type, such as 2 weeks for neurosyphilis and 8 weeks for brain abscess. Data on timing of hospital admission, diagnostic procedures, and antibiotic treatment are collected from hospital records. The study's main measure is the yearly incidence of CNS infections, capturing clinical course and patient outcomes to improve understanding of these serious infections over time.
CONDITIONS
Brief Title
Central Nervous System Infections in Denmark
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Diagnosis of community-acquired central nervous system infection
- Clinical presentation consistent with viral meningitis, bacterial meningitis, encephalitis, brain abscess, neuroborreliosis, or neurosyphilis
- Specific diagnostic criteria met for each infection type, including cerebrospinal fluid leukocytes count and positive microbiological or serological tests as applicable
- No alternative diagnosis more likely than CNS infection after multidisciplinary work-up
You will not qualify if you...
- Diagnosis of autoimmune encephalitis
- Cases where an alternative diagnosis is considered more probable than CNS infection
- Patients not meeting clinical or laboratory criteria for defined CNS infections
- Lack of sufficient diagnostic work-up to confirm CNS infection
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - At admission and shortly thereafter
Participants undergo diagnostic work-up including timing of lumbar puncture, cranial imaging, and evaluation of clinical symptoms to confirm CNS infection diagnosis.
1 visit at hospital admission
Duration - Up to 8 weeks or longer depending on infection type
Participants are observed for clinical outcomes including Glasgow Outcome Scale scores at various time points depending on infection type.
Follow-up assessments at approximately 2 weeks, 4 weeks, and 8 weeks depending on infection
Trial Site Locations
Total: 8 locations
1
Department of Infectious Diseases, Aalborg University Hospital
Aalborg, Denmark, 9000
Actively Recruiting
2
Department of Infectious Diseases, Aarhus University Hospital Skejby
Aarhus, Denmark, 8000
Actively Recruiting
3
Department of Infectious Diseases, Rigshospitalet
Copenhagen, Denmark, 2100
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4
Herlev-Gentofte Hospital
Copenhagen, Denmark
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5
Department of Pulmonary and Infectious Diseases, Nordsjællands Hospital Hillerød
Hillerød, Denmark, 3400
Actively Recruiting
6
Department of Infectious Diseases, Hvidovre Hospital
Hvidovre, Denmark, 2650
Actively Recruiting
7
Department of Infectious Diseases, Odense University Hospital
Odense, Denmark, 5100
Actively Recruiting
8
Department of Pulmonary and Infectious Diseases, Sjællands University Hospital Roskilde
Roskilde, Denmark, 4000
Actively Recruiting
Research Team
J
Jacob Bodilsen, MD
H
Henrik Nielsen, Professor
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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