Central Nervous System Infections in Denmark

NCT03418441 | Recruiting

• 1 other identifier: DASGIB
• Study Type: observational
• Target: 1,900
• Locations: 1 country
• Sites: 8

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Incidence

  Incidence of CNS infections in the adult population (\>17 years of age) in Denmark.

  One year

Secondary Outcomes (7)

• Glasgow Outcome Scale score

  One month after end of treatment

• Glasgow Outcome Scale score for viral meningitis

  30 days

• Glasgow Outcome Scale score for bacterial meningitis

  30 days

• Glasgow Outcome Scale score for encephalitis

  30 days

• Glasgow Outcome Scale score for neurosyphilis

  2 weeks

Interventions

Community-acquired CNS infections OTHER

Prospective observational registration of clinical characteristics and outcome

Also known as: bacterial meningitis, viral meningitis, encephalitis, brain abscess, neuroborreliosis, neurosyphilis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• \- 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.
• 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.

You may not qualify if:

• \- We exclude cases of proven or suspected autoimmune encephalitis.
• \- 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
• \- Aspiration of pus from the brain abscess
• \- Response to antimicrobial treatment
• \- Tumour ruled out
• \- Tumour thought less probable than abscess on MRI using diffusion weighted imaging (DWI) and apparent diffusion coefficient (ADC) sequences.
• \- A clinical presentation consistent with neuroborreliosis (e.g. radiculopathy)
• and
• \- CSF pleocytosis\>10 leukocytes/mL
• and
• \- Positive intrathecal B.burgdorferi antibody production index.
• and either
• \- Positive syphilis serology in serum combined with CSF leukocytes\>10/mL

Sponsors & Collaborators

• Aalborg University Hospital: lead
• Danish Study Group of Infections of the Brain: collaborator

Study Sites (8)

Department of Infectious Diseases, Aalborg University Hospital

Aalborg, 9000, Denmark

RECRUITING

Department of Infectious Diseases, Aarhus University Hospital Skejby

Aarhus, 8000, Denmark

RECRUITING

Department of Infectious Diseases, Rigshospitalet

Copenhagen, 2100, Denmark

RECRUITING

Herlev-Gentofte Hospital

Copenhagen, Denmark

RECRUITING

Department of Pulmonary and Infectious Diseases, Nordsjællands Hospital Hillerød

Hillerød, 3400, Denmark

RECRUITING

Department of Infectious Diseases, Hvidovre Hospital

Hvidovre, 2650, Denmark

RECRUITING

Department of Infectious Diseases, Odense University Hospital

Odense, 5100, Denmark

RECRUITING

Department of Pulmonary and Infectious Diseases, Sjællands University Hospital Roskilde

Roskilde, 4000, Denmark

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood and CSF samples are stored whenever available

MeSH Terms

Conditions

Central Nervous System Infections; Meningitis, Bacterial; Meningitis, Viral; Meningitis, Aseptic; Encephalitis; Brain Abscess; Neurosyphilis; Lyme Disease; Syphilis, tertiary; Meningitis

Condition Hierarchy (Ancestors)

Infections; Central Nervous System Diseases; Nervous System Diseases; Central Nervous System Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Neuroinflammatory Diseases; Central Nervous System Viral Diseases; Virus Diseases; Brain Diseases; Abscess; Suppuration; Syphilis; Treponemal Infections; Spirochaetales Infections; Gram-Negative Bacterial Infections; Borrelia Infections; Tick-Borne Diseases; Vector Borne Diseases

Study Officials

• Henrik Nielsen, Professor

  Aalborg University Hospital

  STUDY CHAIR

Central Study Contacts

Jacob Bodilsen, MD

CONTACT

+45 99663920; jacob.bodilsen@rn.dk

Henrik Nielsen, Professor

CONTACT

+45 99663920; henrik.nielsen@rn.dk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: January 12, 2018
• First Posted: February 1, 2018
• Study Start: January 1, 2015
• Primary Completion (Estimated): January 1, 2030
• Study Completion (Estimated): January 1, 2030
• Last Updated: May 16, 2024

Record last verified: 2024-05

Locations

DK (8)