Severe Acute Respiratory Infections (SARI) in Belgium (2011-2020) (SARIpreSC2)

September 5, 2023 updated by: Cyril Barbezange, Sciensano

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

12145

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
SARI case
Diagnostic test: respiratory specimen
nasopharyngeal swab or nasal aspiration or broncho-alveolar lavage

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants positive for influenza viruses
Time Frame: within 10 days after symptom onset
result of influenza PCR detection test (typing and subtyping)
within 10 days after symptom onset
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)
within 10 days after symptom onset (only routinely tested since influenza season 2015-2016)
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
from date of hospital admission until date of death during hospitalization or date of hospital exit

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sciensano

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 20, 2012

Primary Completion (Actual)

April 2, 2020

Study Completion (Actual)

April 2, 2020

Study Registration Dates

First Submitted

November 9, 2022

First Submitted That Met QC Criteria

November 11, 2022

First Posted (Actual)

November 17, 2022

Study Record Updates

Last Update Posted (Actual)

September 8, 2023

Last Update Submitted That Met QC Criteria

September 5, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SARI-11-20

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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