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

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.

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Key information

Conditions

Influenza Viral Infections Respiratory Viral Infection Severe Acute Respiratory Infection

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

respiratory specimen

Diagnostic Test

nasopharyngeal swab or nasal aspiration or broncho-alveolar lavage

Primary outcomes

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

Secondary outcomes

Number of participants with at least one known risk factor

Time frame: on date of hospital admission

existence of co-morbidities or known risk factors among a list provided on form
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

occurence of complications (among a list provided on form) during hospitalisation stay

Sponsors and collaborators

Lead sponsor

Sciensano

Other Gov

Collaborators

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

Registry information

Official study title

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

Acronym: SARIpreSC2

Important dates

Study start: 2012
Primary completion: 2020
Study completion: 2020
First posted: Nov 17, 2022
Registry last updated: Sep 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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