Monitoring central nervous system infections in Denmark

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

This study is looking at how community-acquired central nervous system infections, like meningitis and encephalitis, affect adults in Denmark to better understand their symptoms, treatments, and recovery outcomes.

Quick facts

• Study type: Observational
• Enrollment: 1900 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Aalborg University Hospital (Academic / other)
• Locations: 8 sites (Aalborg and 7 other locations)
• Trial ID: NCT03418441 on ClinicalTrials.gov

What this trial studies

This observational study involves a nationwide prospective cohort of adult patients diagnosed with community-acquired central nervous system infections in Denmark. It aims to collect and analyze data on clinical characteristics, diagnostic work-up, treatment, and outcomes, specifically focusing on conditions like bacterial and viral meningitis and encephalitis. The study utilizes a collaborative approach among various infectious disease departments across the country to ensure comprehensive data collection and quality control. The outcomes will be assessed using the Glasgow Outcome Score to evaluate the impact of these infections on patients' health.

Who should consider this trial

Good fit: Ideal candidates for this study are adults over 17 years old who present with symptoms consistent with central nervous system infections.

Not a fit: Patients with alternative diagnoses that are more likely than a central nervous system infection will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance understanding of central nervous system infections, leading to improved diagnosis and treatment strategies for patients.

How similar studies have performed: Other studies have shown success in monitoring epidemiological trends in infectious diseases, suggesting that this approach could yield valuable insights.

Eligibility criteria

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.

Where this trial is running

Aalborg and 7 other locations

• Department of Infectious Diseases, Aalborg University Hospital — Aalborg, Denmark (Recruiting)
• Department of Infectious Diseases, Aarhus University Hospital Skejby — Aarhus, Denmark (Recruiting)
• Department of Infectious Diseases, Rigshospitalet — Copenhagen, Denmark (Recruiting)
• Herlev-Gentofte Hospital — Copenhagen, Denmark (Recruiting)
• Department of Pulmonary and Infectious Diseases, Nordsjællands Hospital Hillerød — Hillerød, Denmark (Recruiting)
• Department of Infectious Diseases, Hvidovre Hospital — Hvidovre, Denmark (Recruiting)
• Department of Infectious Diseases, Odense University Hospital — Odense, Denmark (Recruiting)
• Department of Pulmonary and Infectious Diseases, Sjællands University Hospital Roskilde — Roskilde, Denmark (Recruiting)

Study contacts

• Study coordinator: Jacob Bodilsen, MD

Conditions Central Nervous System Infections; Bacterial Meningitis; Viral Meningitis; Aseptic Meningitis; Encephalitis; Brain Abscess; Neuroborreliosis; Neurosyphilis