Central Nervous System Infections in Denmark

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAalborg University Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

CSF leukocytes> 10/mL and no other more probable diagnosis assessed by the local investigator.

Disqualifiers

None

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Community-acquired CNS infections

    Other intervention

    Prospective observational registration of clinical characteristics and outcome

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

Incidence

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

Time frame
One year

Secondary outcomes

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

Time frame
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

Time frame
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

Time frame
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

Time frame
30 days

Other outcomes

Sponsors and contacts

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Aalborg University Hospital

Lead sponsor

Danish Study Group of Infections of the Brain

Collaborator