EncephalitisNCT05370573
Brazil ICU Encephalitis Surveillance
An observational study of Encephalitis and Central Nervous System Infections and Inflammations, run by D'Or Institute for Research and Education at 1 site in Brazil.
Trial 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 intensive approach on a smaller number of cases, "syndromic" to guarantee a sensitive criterion to include new or… Read more about this study
- Who is it for?
- Ages 1 month and older
- Conditions the study is for
- Encephalitis, Central Nervous System Infections and Inflammations, Intensive Care Neurological Disorder
- How many people
- 451 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Jun 2019to 1 Jan 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: This multicentric retrospective cohort study in the metropolitan area of Rio de Janeiro RJ, Brazil, where lived 12 million inhabitants in 201814, involved 35 ICUs (600 beds) of eight hospitals covered with the Epimed Monitor database, which routinely registers most admissions in ICUs: the Evandro Chagas National Institute of Infectology (INI), from january 2012 to june 2019; the seven largest hospitals of the Rede D'Or private health corporation - Barra D'Or, Caxias D'Or, Copa D'Or, Niterói D'Or, Norte D'Or, Oeste D'Or and Quinta D'Or, from january 2015 to december 2019 -, and the Complexo Hospitalar de Niterói (CHN) hospital, a large private health complex, from january 2012 to december 2019.
Who may be able to join
- 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:
Show all 11Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Instituto Nacional de Infectologia
Rio de Janeiro, Rio de Janeiro, 21040-900
About this study
Official title: Encephalitis Sentinel Surveillance in Intensive Care Units in Brazil
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 intensive approach on a smaller number of cases, "syndromic" to guarantee a sensitive criterion to include new or unexpected pathogens, and in ICUs to prioritize potentially severe threats. In a resource-limited setting it won't be possible to monitor and investigate all cases of encephalitis, so a cost-effective algorithm for early identification of the cases that are most likely to be caused by unusual, unexpected or emerging pathogens must be developed. As universal surveillance of encephalitis is not recommended in Brazil, data on incidence, causes and prognosis is not available, leaving a gap in the understanding of the epidemiology of this central nervous system disease in the country. This study will review cases of encephalitis admitted in the last five years to ICUs in a large metropolitan area. Its results will help understand the epidemiology of encephalitis in Brazil and will provide data to build a strategy for early identification of outbreaks and of emerging infectious diseases.
Read the 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" to allow a diagnostic intensive approach on a smaller number of cases, "syndromic" to guarantee a sensitive criterion to include new or unexpected pathogens, and in ICUs to prioritize potentially severe threats. In a resource-limited setting it won't be possible to monitor and investigate all cases of encephalitis, so a cost-effective algorithm for early identification of the cases that are most likely to be caused by unusual, unexpected or emerging pathogens must be developed. As universal surveillance of encephalitis is not recommended in Brazil, data on incidence, causes and prognosis is not available, leaving a gap in the understanding of the epidemiology of this central nervous system disease in the country. This study will review cases of encephalitis admitted in the last five years to ICUs in a large metropolitan area. Its results will help understand the epidemiology of encephalitis in Brazil and will provide data to build a strategy for early identification of outbreaks and of emerging infectious diseases.
We will use data of a sentinel sample of 19 ICUs of nine of the largest hospitals in the metropolitan area of Rio de Janeiro - Brazil (12 million inhabitants in 2018), from 2015 to 2018, covered with the Epimed Monitor database, which routinely registers all admissions in ICUs. The Epimed Monitor system is present in more than 400 hospitals throughout Brazil, with 750 ICUs and 11,000 monitored beds, reaching over 1,000,000 patients within its base (http://www.utisbrasileiras.com.br/en/epimed/)(Zampieri et al. 2017). Based on previous studies (Boucher et al. 2017; Soares et al. 2011), we expect to identify between 100 and 250 cases of encephalitis.
- Conditions
- Encephalitis, Central Nervous System Infections and Inflammations, Intensive Care Neurological Disorder, Prognosis, Meningitis/Encephalitis, Meningitis
- Being tested
- No intervention
- Keywords
- central nervous system infections, encephalitis, surveillance, critical care, prognosis, meningitis
- Medical subject headings
- Encephalitis, Central Nervous System Infections, Inflammation, Meningitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
Observational - no interventions
| Study group | Role | What they receive |
|---|---|---|
| Patients with central nervous system infections admitted to intensive care | Not described Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
In-hospital mortality
Measured: January 2012 to December 2019
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2022
- Study start1 Jun 2019
- Primary completion1 Jun 2020
- Study completion1 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for EncephalitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 451 participants (actual)
Sponsor and investigators
- Lead sponsor
- D'Or Institute for Research and Education
- Sponsor type
- University, hospital or other
- Collaborators
- Oswaldo Cruz Foundation, Centers for Disease Control and Prevention
- Responsible party
- Principal investigator, Hugo Boechat, Oswaldo Cruz Foundation
- Investigators
- ANDRE M JAPIASSU, MD PDH, Principal investigator, Instituto Nacional de Infectologia Evandro Chagas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05370573
- Sponsor's protocol ID
- 16876819.9.0000.5262
- Status last verified
- May 2022
- First submitted
- 7 May 2022
- Last updated
- 11 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Andrade HB, da Silva IRF, Espinoza R, Ferreira MT, da Silva MST, Theodoro PHN, Detepo PJT, Varela MC, Ramos GV, da Silva AR, Soares J, Belay ED, Sejvar JJ, Bozza FA, Cerbino-Neto J, Japiassu AM. Clinical features, etiologies, and outcomes of central nervous system infections in intensive care: A multicentric retrospective study in a large Brazilian metropolitan area. J Crit Care. 2024 Feb;79:154451. doi: 10.1016/j.jcrc.2023.154451. Epub 2023 Oct 21.
PubMed 37871403
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Encephalitis Sentinel Surveillance in Intensive Care Units in Brazil
- ClinicalTrials.gov ID
- NCT05370573
- Acronym / sponsor ID
- 16876819.9.0000.5262
- Conditions
- Encephalitis, Central Nervous System Infections and Inflammations, Intensive Care Neurological Disorder, Prognosis, Meningitis/Encephalitis, Meningitis
- Keywords
- central nervous system infections, encephalitis, surveillance, critical care, prognosis, meningitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 451 participants (actual)
- Lead sponsor
- D'Or Institute for Research and EducationUniversity, hospital or other
- Collaborators
- Oswaldo Cruz Foundation, Centers for Disease Control and Prevention
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 1 Jun 2020 (actual)
- Study completion
- 1 Jan 2022 (actual)
- First posted
- 11 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 intensive approach on a smaller number of cases, "syndromic" to guarantee a sensitive criterion to include new or unexpected pathogens, and in ICUs to prioritize potentially severe threats. In a resource-limited setting it won't be possible to monitor and investigate all cases of encephalitis, so a cost-effective algorithm for early identification of the cases that are most likely to be caused by unusual, unexpected or emerging pathogens must be developed. As universal surveillance of encephalitis is not recommended in Brazil, data on incidence, causes and prognosis is not available, leaving a gap in the understanding of the epidemiology of this central nervous system disease in the country. This study will review cases of encephalitis admitted in the last five years to ICUs in a large metropolitan area. Its results will help understand the epidemiology of encephalitis in Brazil and will provide data to build a strategy for early identification of outbreaks and of emerging infectious diseases.
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" to allow a diagnostic intensive approach on a smaller number of cases, "syndromic" to guarantee a sensitive criterion to include new or unexpected pathogens, and in ICUs to prioritize potentially severe threats. In a resource-limited setting it won't be possible to monitor and investigate all cases of encephalitis, so a cost-effective algorithm for early identification of the cases that are most likely to be caused by unusual, unexpected or emerging pathogens must be developed. As universal surveillance of encephalitis is not recommended in Brazil, data on incidence, causes and prognosis is not available, leaving a gap in the understanding of the epidemiology of this central nervous system disease in the country. This study will review cases of encephalitis admitted in the last five years to ICUs in a large metropolitan area. Its results will help understand the epidemiology of encephalitis in Brazil and will provide data to build a strategy for early identification of outbreaks and of emerging infectious diseases.
We will use data of a sentinel sample of 19 ICUs of nine of the largest hospitals in the metropolitan area of Rio de Janeiro - Brazil (12 million inhabitants in 2018), from 2015 to 2018, covered with the Epimed Monitor database, which routinely registers all admissions in ICUs. The Epimed Monitor system is present in more than 400 hospitals throughout Brazil, with 750 ICUs and 11,000 monitored beds, reaching over 1,000,000 patients within its base (http://www.utisbrasileiras.com.br/en/epimed/)(Zampieri et al. 2017). Based on previous studies (Boucher et al. 2017; Soares et al. 2011), we expect to identify between 100 and 250 cases of encephalitis.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with central nervous system infections admitted to intensive care | – | Other: No intervention |
Who may qualify
- Ages
- 1 month and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- This multicentric retrospective cohort study in the metropolitan area of Rio de Janeiro RJ, Brazil, where lived 12 million inhabitants in 201814, involved 35 ICUs (600 beds) of eight hospitals covered with the Epimed Monitor database, which routinely registers most admissions in ICUs: the Evandro Chagas National Institute of Infectology (INI), from january 2012 to june 2019; the seven largest hospitals of the Rede D'Or private health corporation - Barra D'Or, Caxias D'Or, Copa D'Or, Niterói D'Or, Norte D'Or, Oeste D'Or and Quinta D'Or, from january 2015 to december 2019 -, and the Complexo Hospitalar de Niterói (CHN) hospital, a large private health complex, from january 2012 to december 2019.
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionObservational - no interventions | Other | Patients with central nervous system infections admitted to intensive care |
Primary outcome
In-hospital mortality
Time frame: January 2012 to December 2019
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2022.
- Derived from this study: PubMed 37871403Andrade HB, da Silva IRF, Espinoza R, Ferreira MT, da Silva MST, Theodoro PHN, Detepo PJT, Varela MC, Ramos GV, da Silva AR, Soares J, Belay ED, Sejvar JJ, Bozza FA, Cerbino-Neto J, Japiassu AM. Clinical features, etiologies, and outcomes of central nervous system infections in intensive care: A multicentric retrospective study in a large Brazilian metropolitan area. J Crit Care. 2024 Feb;79:154451. doi: 10.1016/j.jcrc.2023.154451. Epub 2023 Oct 21.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ANDRE M JAPIASSU, MD PDH principal investigator
Instituto Nacional de Infectologia Evandro Chagas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Encephalitis and Central Nervous System Infections and Inflammations, run by D'Or Institute for Research and Education at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
In-hospital mortality (time frame: January 2012 to December 2019). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05370573, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2022.