NCT03418441 Central Nervous System Infections in Denmark
| NCT ID | NCT03418441 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Aalborg University Hospital |
| Condition | Central Nervous System Infections |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,900 participants |
| Start Date | 2015-01-01 |
| Primary Completion | 2030-01-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,900 participants in total. It began in 2015-01-01 with a primary completion date of 2030-01-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Henrik Nielsen, Professor
STUDY CHAIR
Aalborg University Hospital
Frequently Asked Questions
Who can join the NCT03418441 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Central Nervous System Infections. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03418441 currently recruiting?
Yes, NCT03418441 is actively recruiting participants. Contact the research team at jacob.bodilsen@rn.dk for enrollment information.
Where is the NCT03418441 trial being conducted?
This trial is being conducted at Aalborg, Denmark, Aarhus, Denmark, Copenhagen, Denmark, Copenhagen, Denmark and 4 additional locations.
Who is sponsoring the NCT03418441 clinical trial?
NCT03418441 is sponsored by Aalborg University Hospital. The principal investigator is Henrik Nielsen, Professor at Aalborg University Hospital. The trial plans to enroll 1,900 participants.