Influenza Viral InfectionsSARIpreSC2NCT05620953
Severe Acute Respiratory Infections (SARI) in Belgium (2011-2020)
An observational study of Influenza Viral Infections and Respiratory Viral Infection, run by Sciensano.
Trial summary
The Belgian Severe Acute Respiratory Infections network (BELSARI-net) was implemented during the influenza season 2011-2012 following the recommendations of the World Health Organization (WHO) to monitor severity of influenza viruses in hospitals. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Influenza Viral Infections, Respiratory Viral Infection, Severe Acute Respiratory Infection
- What is being tested?
- respiratory specimen
- How many people
- 12,145 participants
- Where
- No sites listed yet
- Study dates
- 20 Jan 2012to 2 Apr 2020
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients admitted to one of the 6 participating hospital during the season surveillance dates.
Who may be able to join
- All pediatric and adult patients admitted to one of the 6 sentinel hospitals during the active surveillance and fulfilling the case definition of acute respiratory infection with onset within the last ten days, with history of fever or measured fever of ≥38°C, with cough and/or dyspnea, and overnight hospitalization.
Who cannot join
- nosocomial infection, i.e. symptoms appearing after admission
About this study
Official title: Severe Acute Respiratory Infections Surveillance in Belgium (2011-2020, Prior to COVID-19 Pandemic)
The Belgian Severe Acute Respiratory Infections network (BELSARI-net) was implemented during the influenza season 2011-2012 following the recommendations of the World Health Organization (WHO) to monitor severity of influenza viruses in hospitals. The network is composed of 6 hospitals throughout the country, two in each administrative region (Flanders, Wallonia and Brussels-Capital), and operates during the influenza epidemic period (from the last week of December or first/second week of January to the third/last week of April, depending on when influenza virus circulation is detected by the general population, based on the Influenza-like illness (ILI) network of general practitioners).
Enrollment is performed for all cases matching the SARI case definition (based on WHO's case definition) and accepting to take part. A respiratory specimen is sampled systematically from each participant, and detailed clinico-epidemiological data, such as information on age, sex, symptoms and potential risk factors such as pregnancy or comorbidities (chronic respiratory diseases, asthma, chronic cardiovascular diseases, renal insufficiency, obesity, diabetes, hepatic or renal insufficiency, immunodeficiency, neuromuscular disease, pregnancy) is also collected. Participants are followed up during hospitalization for the occurrence of complications (detection of pneumonia based on chest radiography, development of acute respiratory distress syndrome (ARDS), requirement for respiratory assistance and/or for extracorporeal membrane oxygenation (ECMO), admission in intensive care unit (ICU)), or death (all-cause death).
The current project includes all the samples received by the Belgian National Influenza Centre (NIC) during the influenza seasons 2011-2012 till 2019-2020.
- Conditions
- Influenza Viral Infections, Respiratory Viral Infection, Severe Acute Respiratory Infection
- Being tested
- respiratory specimen
- Keywords
- sentinel surveillance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
respiratory specimenDiagnostic test
nasopharyngeal swab or nasal aspiration or broncho-alveolar lavage
| Study group | Role | What they receive |
|---|---|---|
| SARI case | Not described Receives: Diagnostic Test: respiratory specimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants positive for influenza viruses
result of influenza PCR detection test (typing and subtyping)
Measured: within 10 days after symptom onset
Number of participants positive for non-influenza viruses
results of non-influenza multiplex PCR detection test (16 targets)
Measured: within 10 days after symptom onset (only routinely tested since influenza season 2015-2016)
Number of participants who died during hospitalization
alive or dead
Measured: from date of hospital admission until date of death during hospitalization or date of hospital exit
Secondary outcomes (2)
Number of participants with at least one known risk factor
existence of co-morbidities or known risk factors among a list provided on form
Measured: on date of hospital admission
Number of participants who experienced at least one complication
occurence of complications (among a list provided on form) during hospitalisation stay
Measured: from date of hospital admission until date of death during hospitalization or date of hospital exit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2022
- Study start20 Jan 2012
- Primary completion2 Apr 2020
- Study completion2 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Influenza Viral InfectionsStudies 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 12,145 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sciensano
- Sponsor type
- Other government
- Collaborators
- Belgian Federal Public Service, Food Chain Safety and Environment, Centre Hospitalier Universitaire Saint Pierre, AZ Sint-Jan AV, Universitair Ziekenhuis Brussel, Grand Hôpital de Charleroi, Jessa Hospital, Centre Hospitalier Universitaire UCLouvain Namur
- Responsible party
- Principal investigator, Cyril Barbezange, Sciensano
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05620953
- Sponsor's protocol ID
- SARI-11-20
- Acronym
- SARIpreSC2
- Status last verified
- Sep 2023
- First submitted
- 9 Nov 2022
- Last updated
- 8 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Subissi L, Bossuyt N, Reynders M, Gerard M, Dauby N, Lacor P, Daelemans S, Lissoir B, Holemans X, Magerman K, Jouck D, Bourgeois M, Delaere B, Quoilin S, Van Gucht S, Thomas I, Barbezange C. Spotlight influenza: Extending influenza surveillance to detect non-influenza respiratory viruses of public health relevance: analysis of surveillance data, Belgium, 2015 to 2019. Euro Surveill. 2021 Sep;26(38):2001104. doi: 10.2807/1560-7917.ES.2021.26.38.2001104.
PubMed 34558405Fischer N, Dauby N, Bossuyt N, Reynders M, Gerard M, Lacor P, Daelemans S, Lissoir B, Holemans X, Magerman K, Jouck D, Bourgeois M, Delaere B, Quoilin S, Van Gucht S, Thomas I, Barbezange C, Subissi L. Monitoring of human coronaviruses in Belgian primary care and hospitals, 2015-20: a surveillance study. Lancet Microbe. 2021 Mar;2(3):e105-e114. doi: 10.1016/S2666-5247(20)30221-4. Epub 2021 Jan 27.
PubMed 33937883Subissi L, Bossuyt N, Reynders M, Gerard M, Dauby N, Bourgeois M, Delaere B, Quoilin S, Van Gucht S, Thomas I, Barbezange C. Capturing respiratory syncytial virus season in Belgium using the influenza severe acute respiratory infection surveillance network, season 2018/19. Euro Surveill. 2020 Oct;25(39):1900627. doi: 10.2807/1560-7917.ES.2020.25.39.1900627.
PubMed 33006303Fischer N, Moreels S, Dauby N, Reynders M, Petit E, Gerard M, Lacor P, Daelemans S, Lissoir B, Holemans X, Magerman K, Jouck D, Bourgeois M, Delaere B, Quoilin S, Van Gucht S, Thomas I, Bossuyt N, Barbezange C. Influenza versus other respiratory viruses - assessing severity among hospitalised children, Belgium, 2011 to 2020. Euro Surveill. 2023 Jul;28(29):2300056. doi: 10.2807/1560-7917.ES.2023.28.29.2300056.
PubMed 37470740
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Severe Acute Respiratory Infections Surveillance in Belgium (2011-2020, Prior to COVID-19 Pandemic)
- ClinicalTrials.gov ID
- NCT05620953
- Acronym / sponsor ID
- SARIpreSC2 / SARI-11-20
- Conditions
- Influenza Viral Infections, Respiratory Viral Infection, Severe Acute Respiratory Infection
- Keywords
- sentinel surveillance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12,145 participants (actual)
- Lead sponsor
- SciensanoOther government
- Collaborators
- Belgian Federal Public Service, Food Chain Safety and Environment, Centre Hospitalier Universitaire Saint Pierre, AZ Sint-Jan AV, Universitair Ziekenhuis Brussel, Grand Hôpital de Charleroi, Jessa Hospital, Centre Hospitalier Universitaire UCLouvain Namur
- Study start
- 20 Jan 2012 (actual)
- Primary completion
- 2 Apr 2020 (actual)
- Study completion
- 2 Apr 2020 (actual)
- First posted
- 17 Nov 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.
The Belgian Severe Acute Respiratory Infections network (BELSARI-net) was implemented during the influenza season 2011-2012 following the recommendations of the World Health Organization (WHO) to monitor severity of influenza viruses in hospitals. The network is composed of 6 hospitals throughout the country, two in each administrative region (Flanders, Wallonia and Brussels-Capital), and operates during the influenza epidemic period (from the last week of December or first/second week of January to the third/last week of April, depending on when influenza virus circulation is detected by the general population, based on the Influenza-like illness (ILI) network of general practitioners).
Enrollment is performed for all cases matching the SARI case definition (based on WHO's case definition) and accepting to take part. A respiratory specimen is sampled systematically from each participant, and detailed clinico-epidemiological data, such as information on age, sex, symptoms and potential risk factors such as pregnancy or comorbidities (chronic respiratory diseases, asthma, chronic cardiovascular diseases, renal insufficiency, obesity, diabetes, hepatic or renal insufficiency, immunodeficiency, neuromuscular disease, pregnancy) is also collected. Participants are followed up during hospitalization for the occurrence of complications (detection of pneumonia based on chest radiography, development of acute respiratory distress syndrome (ARDS), requirement for respiratory assistance and/or for extracorporeal membrane oxygenation (ECMO), admission in intensive care unit (ICU)), or death (all-cause death).
The current project includes all the samples received by the Belgian National Influenza Centre (NIC) during the influenza seasons 2011-2012 till 2019-2020.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SARI case | – | Diagnostic Test: respiratory specimen |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients admitted to one of the 6 participating hospital during the season surveillance dates.
Key inclusion criteria (1 listed)
- All pediatric and adult patients admitted to one of the 6 sentinel hospitals during the active surveillance and fulfilling the case definition of acute respiratory infection with onset within the last ten days, with history of fever or measured fever of ≥38°C, with cough and/or dyspnea, and overnight hospitalization.
Key exclusion criteria (1 listed)
- nosocomial infection, i.e. symptoms appearing after admission
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 |
|---|---|---|
| respiratory specimennasopharyngeal swab or nasal aspiration or broncho-alveolar lavage | Diagnostic test | SARI case |
Primary outcome
Number of participants positive for influenza viruses
Time frame: within 10 days after symptom onset
result of influenza PCR detection test (typing and subtyping)
Number of participants positive for non-influenza viruses
Time frame: within 10 days after symptom onset (only routinely tested since influenza season 2015-2016)
results of non-influenza multiplex PCR detection test (16 targets)
Number of participants who died during hospitalization
Time frame: from date of hospital admission until date of death during hospitalization or date of hospital exit
alive or dead
2 secondary outcomes
Number of participants with at least one known risk factor
Time frame: on date of hospital admission
Number of participants who experienced at least one complication
Time frame: from date of hospital admission until date of death during hospitalization or date of hospital exit
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 8 Sep 2023.
- Results publication: PubMed 34558405Subissi L, Bossuyt N, Reynders M, Gerard M, Dauby N, Lacor P, Daelemans S, Lissoir B, Holemans X, Magerman K, Jouck D, Bourgeois M, Delaere B, Quoilin S, Van Gucht S, Thomas I, Barbezange C. Spotlight influenza: Extending influenza surveillance to detect non-influenza respiratory viruses of public health relevance: analysis of surveillance data, Belgium, 2015 to 2019. Euro Surveill. 2021 Sep;26(38):2001104. doi: 10.2807/1560-7917.ES.2021.26.38.2001104.
- Results publication: PubMed 33937883Fischer N, Dauby N, Bossuyt N, Reynders M, Gerard M, Lacor P, Daelemans S, Lissoir B, Holemans X, Magerman K, Jouck D, Bourgeois M, Delaere B, Quoilin S, Van Gucht S, Thomas I, Barbezange C, Subissi L. Monitoring of human coronaviruses in Belgian primary care and hospitals, 2015-20: a surveillance study. Lancet Microbe. 2021 Mar;2(3):e105-e114. doi: 10.1016/S2666-5247(20)30221-4. Epub 2021 Jan 27.
- Results publication: PubMed 33006303Subissi L, Bossuyt N, Reynders M, Gerard M, Dauby N, Bourgeois M, Delaere B, Quoilin S, Van Gucht S, Thomas I, Barbezange C. Capturing respiratory syncytial virus season in Belgium using the influenza severe acute respiratory infection surveillance network, season 2018/19. Euro Surveill. 2020 Oct;25(39):1900627. doi: 10.2807/1560-7917.ES.2020.25.39.1900627.
- Results publication: PubMed 37470740Fischer N, Moreels S, Dauby N, Reynders M, Petit E, Gerard M, Lacor P, Daelemans S, Lissoir B, Holemans X, Magerman K, Jouck D, Bourgeois M, Delaere B, Quoilin S, Van Gucht S, Thomas I, Bossuyt N, Barbezange C. Influenza versus other respiratory viruses - assessing severity among hospitalised children, Belgium, 2011 to 2020. Euro Surveill. 2023 Jul;28(29):2300056. doi: 10.2807/1560-7917.ES.2023.28.29.2300056.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Influenza Viral Infections and Respiratory Viral Infection, run by Sciensano.
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 1 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 8 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Number of participants positive for influenza viruses (time frame: within 10 days after symptom onset). The study lists 3 primary outcomes in all. 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 NCT05620953, which also lists 4 linked publications.
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 8 Sep 2023.