Status:
COMPLETED
Brazil ICU Encephalitis Surveillance
Lead Sponsor:
D'Or Institute for Research and Education
Collaborating Sponsors:
Oswaldo Cruz Foundation
Centers for Disease Control and Prevention
Conditions:
Encephalitis
Central Nervous System Infections and Inflammations
Eligibility:
All Genders
1+ years
Brief Summary
Our proposal is to develop a sentinel syndromic surveillance strategy to identify encephalitis cases possibly related to emerging pathogens admitted to ICUs in Brazil. "Sentinel" to allow a diagnostic...
Detailed Description
Our proposal is to develop a sentinel syndromic surveillance strategy to identify encephalitis cases possibly related to emerging pathogens admitted to Intensive Care Units (ICUs) in Brazil. "Sentinel...
Eligibility Criteria
Inclusion
- Identification of suspected case of central nervous system infections in the Epimed Database of non-surgical and non-neonatal ICU admissions: risk greater or equal to 10% - sensitivity of 88.69%, a specificity of 85.57%, area under the Receiver Operating Characteristics (ROC) curve of 0.892 (95% confidence interval 0.864 - 0.921, P\<0.0001) - by a diagnostic prediction tool for central nervous system infection (CNSI) developed by the authors for this study. Suspected cases had their medical records reviewed. Those who fulfilled the diagnostic criteria of CNSI as follows were included as a case:
- Brain abscess or suppurative intracranial infections: diagnosis of brain abscess requires at least one of the following criteria:
- Organism identified from brain tissue
- Abscess on gross anatomic or histopathologic exam
- Two of the following: headache, dizziness, fever, localizing neurological signs, changing level of consciousness or confusion; and one of the following: organism on microscopic examination of brain or abscess tissue, neuroimaging evidence of infection, or diagnostic serology.
- Encephalitis: Involvement of the brain parenchyma by the infectious agent. Diagnosis of encephalitis by Venkatesan et al19 requires:
- Major criteria: Presence of decreased or altered level of consciousness, lethargy or personality change lasting at least 24 hours and exclusion of encephalopathy due to other non-infectious aetiologies
- Two of the following for possible encephalitis, three of the following for probable or confirmed encephalitis: fever, seizures, new onset focal neurological findings, cerebrospinal fluid (CSF) white blood cell (WBC) count \>10x106/L, abnormal neuroimaging and electroencephalography.
- Meningitis: Patients without criteria for encephalitis, and at least one of the following criteria:
- Organism identified from CSF
- The presence of two of the following: fever or headache, meningeal signs or cranial nerve signs (and hypothermia, apnoea, bradycardia or irritability for those under \<1 year of age); and one of the following: increased WBC count (≥5 cells/mm3), increased protein and/or decreased glucose in CSF, an organism on Gram stain or culture, or diagnostic serology.
Exclusion
- Participants without CNSI case definition, readmissions during the period of data collection (only the first admission was evaluated), evidence of nosocomial or postoperative neuroinfection, diseases of inflammatory or autoimmune etiology, missing important data for analysis or diagnosis.
Key Trial Info
Start Date :
June 1 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 1 2022
Estimated Enrollment :
451 Patients enrolled
Trial Details
Trial ID
NCT05370573
Start Date
June 1 2019
End Date
January 1 2022
Last Update
May 11 2022
Active Locations (1)
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1
Instituto Nacional de Infectologia
Rio de Janeiro, Rio de Janeiro, Brazil, 21040-900