Severe Acute Respiratory Infections (SARI) in Belgium (2011-2020)

Respiratory Viral Infection Clinical Trial

— SARIpreSC2  

Official title:

Severe Acute Respiratory Infections Surveillance in Belgium (2011-2020, Prior to COVID-19 Pandemic)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05620953
• Other study ID #: SARI-11-20
• Status: Completed
• Start date: January 20, 2012
• Est. completion date: April 2, 2020

Study information

• Verified date: September 2023
• Source: Sciensano
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12145
• Est. completion date: April 2, 2020
• Est. primary completion date: April 2, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Communicable Diseases
• Infections
• Influenza Viral Infections
• Respiratory Tract Infections
• Respiratory Viral Infection
• Severe Acute Respiratory Infection
• Virus Diseases

Intervention

Diagnostic Test:
• respiratory specimen
nasopharyngeal swab or nasal aspiration or broncho-alveolar lavage

Locations

Country	Name	City	State
n/a

Sponsors (8)

Lead Sponsor	Collaborator
Sciensano	AZ Sint-Jan AV, Belgian Federal Public Service, Food Chain Safety and Environment, Centre Hospitalier Universitaire Saint Pierre, Centre Hospitalier Universitaire UCLouvain Namur, Grand Hôpital de Charleroi, Jessa Hospital, Universitair Ziekenhuis Brussel

References & Publications (4)

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 — View Citation

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 - — View Citation

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 networ — View Citation

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants positive for influenza viruses	result of influenza PCR detection test (typing and subtyping)	within 10 days after symptom onset
Primary	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)
Primary	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	Number of participants with at least one known risk factor	existence of co-morbidities or known risk factors among a list provided on form	on date of hospital admission
Secondary	Number of participants who experienced at least one complication	occurence of complications (among a list provided on form) during hospitalisation stay	from date of hospital admission until date of death during hospitalization or date of hospital exit