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Central Nervous System InfectionsDASGIBNCT03418441

Central Nervous System Infections in Denmark

An observational study of Central Nervous System Infections and Bacterial Meningitis, run by Aalborg University Hospital at 8 sites in Denmark.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Community-acquired CNS infections
How many people
1,900 participants
Where
8 sitesDenmark
Study dates
1 Jan 2015to 1 Jan 2030
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

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.

Trial locations and contacts

8 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Jacob Bodilsen, MD contact

+45 99663920

jacob.bodilsen@rn.dk

Henrik Nielsen, Professor contact

+45 99663920

henrik.nielsen@rn.dk

8 sites in 1 country

Denmark8 sites, 8 recruiting

  • Department of Infectious Diseases, Aalborg University Hospital

    Aalborg, 9000

    Jacob Bodilsen, MD, +45 99663920, jacob.bodilsen@rn.dk

    Henrik Nielsen, Professor, +45 99663920, henrik.nielsen@rn.dk

    Recruiting

  • Department of Infectious Diseases, Aarhus University Hospital Skejby

    Aarhus, 8000

    Merete Storgaard, MD, merestor@rm.dk

    Recruiting

  • Department of Infectious Diseases, Rigshospitalet

    Copenhagen, 2100

    Jannik Helweg-Larsen, MD, Jannik.Helweg-Larsen@regionh.dk

    Recruiting

  • Herlev-Gentofte Hospital

    Copenhagen

    Hans Rudolf Lüttichau, MD

    Recruiting

  • Department of Pulmonary and Infectious Diseases, Nordsjællands Hospital Hillerød

    Hillerød, 3400

    Christian T Brandt, MD, christian.thomas.brandt01@regionh.dk

    Recruiting

  • Department of Infectious Diseases, Hvidovre Hospital

    Hvidovre, 2650

    Birgitte R Hansen, MD, birgitte.roende.hansen@regionh.dk

    Hanse

    Recruiting

  • Department of Infectious Diseases, Odense University Hospital

    Odense, 5100

    Lykke Larsen, MD, lykke.larsen@rsyd.dk

    Recruiting

  • Department of Pulmonary and Infectious Diseases, Sjællands University Hospital Roskilde

    Roskilde, 4000

    Lothar Wiese, MD, low@regionsjaelland.dk

    Recruiting

Other trials in Denmark

About this study

Official title: 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

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.

Read the 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

Being tested
Community-acquired CNS infections
Keywords
Nationwide prospective observational cohort study, Epidemiology, Central Nervous System Infections, Meningitis, Encephalitis, Brain abscess, Lyme disease, Neuroborreliosis, Neurosyphilis, Tertiary syphilis
Medical subject headings
Central Nervous System Infections, Meningitis, Bacterial, Meningitis, Viral, Meningitis, Aseptic, Encephalitis, Brain Abscess, Neurosyphilis, Lyme Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Community-acquired CNS infectionsOther

    Also called bacterial meningitis, viral meningitis, encephalitis, brain abscess

    Prospective observational registration of clinical characteristics and outcome

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence

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

    Measured: One year

Secondary outcomes (7)

  1. 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

    Measured: One month after end of treatment

  2. 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

    Measured: 30 days

  3. 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

    Measured: 30 days

  4. 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

    Measured: 30 days

  5. 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

    Measured: 2 weeks

  6. 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

    Measured: 2 weeks

  7. 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

    Measured: 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Feb 2018
  2. Study start1 Jan 2015
  3. Primary completion1 Jan 2030 (estimated)
  4. Study completion1 Jan 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
1,900 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03418441
Sponsor's protocol ID
DASGIB
Acronym
DASGIB
Status last verified
May 2024
First submitted
12 Jan 2018
Last updated
16 May 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Central Nervous System Infections and Bacterial Meningitis, run by Aalborg University Hospital at 8 sites in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 16 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jacob Bodilsen, MD (+45 99663920, jacob.bodilsen@rn.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence (time frame: One year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03418441.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2024.

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