Central Nervous System Infections in Denmark

NCT ID: NCT03418441

Last Updated: 2024-05-16

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 1900 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-01-01
• Study Completion Date: 2030-01-01

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.

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

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Community-acquired CNS infections

Prospective observational registration of clinical characteristics and outcome

Intervention Type: OTHER

Other Intervention Names

bacterial meningitis; viral meningitis; encephalitis; brain abscess; neuroborreliosis; neurosyphilis

Eligibility Criteria

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.

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.

• 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.

• 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

or

• CSF syphilis antibodies.

Exclusion Criteria

• We exclude cases of proven or suspected autoimmune encephalitis.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Danish Study Group of Infections of the Brain

OTHER

Sponsor Role: collaborator

Aalborg University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jacob Bodilsen

Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Henrik Nielsen, Professor

Role: STUDY_CHAIR

Aalborg University Hospital

Locations

Department of Infectious Diseases, Aalborg University Hospital

Aalborg, , Denmark

Site Status: RECRUITING

Department of Infectious Diseases, Aarhus University Hospital Skejby

Aarhus, , Denmark

Site Status: RECRUITING

Department of Infectious Diseases, Rigshospitalet

Copenhagen, , Denmark

Site Status: RECRUITING

Herlev-Gentofte Hospital

Copenhagen, , Denmark

Site Status: RECRUITING

Department of Pulmonary and Infectious Diseases, Nordsjællands Hospital Hillerød

Hillerød, , Denmark

Site Status: RECRUITING

Department of Infectious Diseases, Hvidovre Hospital

Hvidovre, , Denmark

Site Status: RECRUITING

Department of Infectious Diseases, Odense University Hospital

Odense, , Denmark

Site Status: RECRUITING

Department of Pulmonary and Infectious Diseases, Sjællands University Hospital Roskilde

Roskilde, , Denmark

Site Status: RECRUITING

Countries

Denmark

Central Contacts

Jacob Bodilsen, MD

Role: CONTACT

jacob.bodilsen@rn.dk

+45 99663920

Henrik Nielsen, Professor

Role: CONTACT

henrik.nielsen@rn.dk

+45 99663920

Facility Contacts

Jacob Bodilsen, MD

Role: primary

jacob.bodilsen@rn.dk

+45 99663920

Henrik Nielsen, Professor

Role: backup

henrik.nielsen@rn.dk

+45 99663920

Merete Storgaard, MD

Role: primary

merestor@rm.dk

Jannik Helweg-Larsen, MD

Role: primary

Jannik.Helweg-Larsen@regionh.dk

Hans Rudolf Lüttichau, MD

Role: primary

Christian T Brandt, MD

Role: primary

christian.thomas.brandt01@regionh.dk

Birgitte R Hansen, MD

Role: primary

birgitte.roende.hansen@regionh.dk

Hanse

Role: backup

Lykke Larsen, MD

Role: primary

lykke.larsen@rsyd.dk

Lothar Wiese, MD

Role: primary

low@regionsjaelland.dk

Other Identifiers

DASGIB

Identifier Type: -

Identifier Source: org_study_id