NCT07599449

Brief Summary

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25,000

participants targeted

Target at P75+ for all trials

Timeline
61mo left

Started May 2026

Longer than P75 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 6, 2026

Completed
9 days until next milestone

Study Start

First participant enrolled

May 15, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 20, 2026

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2031

Expected
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 20, 2031

Last Updated

May 20, 2026

Status Verified

May 1, 2026

Enrollment Period

5 years

First QC Date

May 6, 2026

Last Update Submit

May 13, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

    Baseline

Secondary Outcomes (2)

  • Weekly incidence rate of acute respiratory infections caused by influenza viruses and SARS-CoV-2 seen in general practice

    Baseline

  • Proportion of patients included vaccinated against influenza

    Baseline

Study Arms (1)

Individuals with an ARI consulting a GP or a private pediatrician in mainland France

Diagnostic Test: saliva samplingDiagnostic Test: Nasopharyngeal swab

Interventions

saliva samplingDIAGNOSTIC_TEST

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.

Individuals with an ARI consulting a GP or a private pediatrician in mainland France
Nasopharyngeal swabDIAGNOSTIC_TEST

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).

Individuals with an ARI consulting a GP or a private pediatrician in mainland France

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients seen in GPs' consultation with an acute respiratory infection

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

nasopharyngeal swab

MeSH Terms

Conditions

Respiratory Tract InfectionsInfluenza, HumanCOVID-19Respiratory Syncytial Virus Infections

Condition Hierarchy (Ancestors)

InfectionsRespiratory Tract DiseasesOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesPneumonia, ViralPneumoniaCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsLung DiseasesPneumovirus InfectionsParamyxoviridae InfectionsMononegavirales Infections

Study Officials

  • Thierry BLANCHON, MD, PhD

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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Thierry BLANCHON, MD, PhD

CONTACT

Olivier STEICHEN, MD, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 6, 2026

First Posted

May 20, 2026

Study Start

May 15, 2026

Primary Completion (Estimated)

May 15, 2031

Study Completion (Estimated)

May 20, 2031

Last Updated

May 20, 2026

Record last verified: 2026-05