Virological Surveillance of Acute Respiratory Infection in Primary Health Care in Metropolitan France (RS-viro IRA)

May 13, 2026 updated by: Institut National de la Santé Et de la Recherche Médicale, France
Every year in the fall and winter, numerous respiratory viruses (such as influenza viruses, SARS-CoV-2 (COVID-19), RSV, rhinovirus, and metapneumovirus) circulate in mainland France, causing acute respiratory infections (ARIs). These viruses can cause epidemics of varying severity, requiring close monitoring to determine their circulation levels and adapt public health measures accordingly. In France, ARI surveillance relies on two networks: the Sentinelles network in primary care and the RENAL network in hospitals. The Sentinelles surveillance is conducted in collaboration with Santé publique France, the National Reference Center for Respiratory Infection Viruses (Institut Pasteur and Hospices Civils de Lyon), and the University of Corsica. As part of the virological surveillance of ARIs, Sentinelles physicians are asked to collect nasopharyngeal swabs or saliva samples from a sample of patients presenting with an ARI during their clinic visits. This surveillance makes it possible to identify respiratory viruses circulating in primary care (general practice and pediatrics), to describe confirmed cases for each of the circulating viruses, and to estimate the impact of each on general practice. This surveillance also allows for the evaluation of the effectiveness of vaccines against influenza and COVID-19.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

25000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

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 seen in GPs' consultation with an acute respiratory infection

Description

Inclusion Criteria:

  • be seen by a general practitioner or pediatrician participating in the Sentinelles surveillance program;
  • between week 40 (late September-early October) and week 15 (mid-April) of each year
  • have an acute respiratory infection (ARI) as defined below: Sudden onset of fever (or feeling of fever) and respiratory symptoms
  • have given oral consent to participate in this monitoring or, in the case of minors, oral consent given by the child's legal guardian(s) present at the consultation

Exclusion Criteria:

  • a person who is subject to a court-ordered protective measure;
  • a person who is under guardianship or conservatorship, unless accompanied by their legal guardian or unless the legal guardian objects to their participation;
  • a person who is not in a condition to receive information or give consent.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Individuals with an ARI consulting a GP or a private pediatrician in mainland France
Diagnostic test: saliva sampling

Based on the protocol, physicians perform either a nasopharyngeal swab or saliva collection on included patients. The method is determined by scientific data and epidemiological constraints, not by the patient.

Saliva collection:

The physician oversees the collection during the visit using the provided kit (pipette, tube, etc.).

Depending on constraints, the patient may perform the collection at home if agreed upon.

If the patient is unable to self-collect (e.g., infants, facial paralysis), the physician collects the saliva directly from under the tongue using the pipette.

Diagnostic test: Nasopharyngeal swab

Based on the protocol, physicians perform either a nasopharyngeal swab or saliva collection on included patients. The method is determined by scientific data and epidemiological constraints, not by the patient.

Nasopharyngeal sampling: During the consultation, the physician performs a deep nasal swab using the provided kit (FFP2 mask, swab, transport tube, absorbent, SafetyBag, and pre-paid envelope for partner labs).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of acute respiratory infection (ARI) cases seen in private practice (general practice and pediatrics) that tested positive for influenza viruses (by type and subtype), SARS-CoV-2, RSV, rhinovirus, and metapneumovirus
Time Frame: Baseline
Baseline

Secondary Outcome Measures

Outcome Measure
Time Frame
Weekly incidence rate of acute respiratory infections caused by influenza viruses and SARS-CoV-2 seen in general practice
Time Frame: Baseline
Baseline
Proportion of patients included vaccinated against influenza
Time Frame: Baseline
Baseline

Collaborators and Investigators

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

Sponsor

Institut National de la Santé Et de la Recherche Médicale, France

Investigators

  • Principal Investigator: Thierry BLANCHON, MD, PhD, Institut National de la Santé Et de la Recherche Médicale, France

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.

Helpful Links

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 (Estimated)

May 15, 2026

Primary Completion (Estimated)

May 15, 2031

Study Completion (Estimated)

May 20, 2031

Study Registration Dates

First Submitted

May 6, 2026

First Submitted That Met QC Criteria

May 13, 2026

First Posted (Actual)

May 20, 2026

Study Record Updates

Last Update Posted (Actual)

May 20, 2026

Last Update Submitted That Met QC Criteria

May 13, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C21-62

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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