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

Completed

• Conditions: Severe Acute Respiratory Infection; Influenza Viral Infections; Respiratory Viral Infection

• Registration Number: NCT05620953
• Lead Sponsor: Sciensano

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01-20
• Primary Completion: 2020-04-02
• Study Completion: 2020-04-02
• Study First Submitted: 2022-11-09
• Study First Submitted QC: 2022-11-11
• Study First Posted: 2022-11-17
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-05
• Last Update Posted: 2023-09-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12145

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of participants positive for influenza viruses	within 10 days after symptom onset	result of influenza PCR detection test (typing and subtyping)
Number of participants positive for non-influenza viruses	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	from date of hospital admission until date of death during hospitalization or date of hospital exit	alive or dead

Secondary Outcome Measures

Name	Time	Method
Number of participants with at least one known risk factor	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	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