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Central Nervous System Infections in Denmark

Launched by AALBORG UNIVERSITY HOSPITAL · Jan 25, 2018

Trial Information

Current as of June 27, 2025

Recruiting

Keywords

Nationwide Prospective Observational Cohort Study Epidemiology Central Nervous System Infections Meningitis Encephalitis Brain Abscess Lyme Disease Neuroborreliosis Neurosyphilis Tertiary Syphilis

ClinConnect Summary

The Central Nervous System Infections study in Denmark is looking to understand infections that affect the brain and spinal cord, such as meningitis and encephalitis. Researchers are collecting information about adult patients (ages 17 and older) who have been diagnosed with these infections since January 2015. This study aims to track trends and outcomes to improve treatment and care for these serious conditions.

To participate, individuals must have symptoms consistent with certain types of infections, like fever, headache, or confusion, and meet specific medical criteria. For example, those with viral meningitis need to show signs of the illness and have a certain level of white blood cells in their spinal fluid. Participants can expect to undergo tests and evaluations as part of their diagnosis and treatment, and their health information will be carefully monitored throughout the study. This research is important because it helps doctors better understand and manage central nervous system infections, ultimately aiming to enhance patient care and outcomes.

Gender

ALL

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.

About Aalborg University Hospital

Aalborg University Hospital is a leading healthcare institution in Denmark, renowned for its commitment to advancing medical research and patient care. As a prominent clinical trial sponsor, the hospital actively engages in innovative studies aimed at improving health outcomes across various medical disciplines. With a focus on collaboration and interdisciplinary approaches, Aalborg University Hospital leverages its state-of-the-art facilities and expertise to conduct rigorous clinical trials, ensuring adherence to the highest ethical standards and regulatory requirements. The institution is dedicated to fostering a culture of research excellence, contributing valuable insights to the medical community and enhancing treatment options for patients.

Locations

Copenhagen, , Denmark

Aalborg, , Denmark

Aarhus, , Denmark

Copenhagen, , Denmark

Hillerød, , Denmark

Hvidovre, , Denmark

Odense, , Denmark

Roskilde, , Denmark

Patients applied

0 patients applied

Trial Officials

Henrik Nielsen, Professor

Study Chair

Aalborg University Hospital

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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