NCT05620953

Brief 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. 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12,145

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2012

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 20, 2012

Completed
8.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 2, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 2, 2020

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

November 9, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 17, 2022

Completed
Last Updated

September 8, 2023

Status Verified

September 1, 2023

Enrollment Period

8.2 years

First QC Date

November 9, 2022

Last Update Submit

September 5, 2023

Conditions

Keywords

sentinel surveillance

Outcome Measures

Primary Outcomes (3)

  • Number of participants positive for influenza viruses

    result of influenza PCR detection test (typing and subtyping)

    within 10 days after symptom onset

  • Number of participants positive for non-influenza viruses

    results of non-influenza multiplex PCR detection test (16 targets)

    within 10 days after symptom onset (only routinely tested since influenza season 2015-2016)

  • Number of participants who died during hospitalization

    alive or dead

    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

    on date of hospital admission

  • Number of participants who experienced at least one complication

    from date of hospital admission until date of death during hospitalization or date of hospital exit

Study Arms (1)

SARI case

Diagnostic Test: respiratory specimen

Interventions

respiratory specimenDIAGNOSTIC_TEST

nasopharyngeal swab or nasal aspiration or broncho-alveolar lavage

SARI case

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients admitted to one of the 6 participating hospital during the season surveillance dates.

You may qualify if:

  • 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.

You may not qualify if:

  • nosocomial infection, i.e. symptoms appearing after admission

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • 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.

  • Fischer 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.

  • Subissi 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.

  • Fischer 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.

Biospecimen

Retention: SAMPLES WITH DNA

respiratory specimens (mainly nasopharyngeal swabs, but a few nasal aspirates and broncho-alveolar lavages)

MeSH Terms

Interventions

Respiratory Rate

Intervention Hierarchy (Ancestors)

Vital SignsPhysical ExaminationDiagnostic Techniques and ProceduresDiagnosisRespirationRespiratory Physiological PhenomenaCirculatory and Respiratory Physiological Phenomena

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
scientist

Study Record Dates

First Submitted

November 9, 2022

First Posted

November 17, 2022

Study Start

January 20, 2012

Primary Completion

April 2, 2020

Study Completion

April 2, 2020

Last Updated

September 8, 2023

Record last verified: 2023-09