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Recruiting NCT07599449

Virological Surveillance of Acute Respiratory Infection in Primary Health Care in Metropolitan France

Observational Respiratory Tract Infections (RTI) Influenza -Like Illness Influenza COVID - 19

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: saliva sampling, Nasopharyngeal swab.
Who it may be relevant to
Registry conditions: Respiratory Tract Infections (RTI), Influenza -Like Illness, Influenza, COVID - 19. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • 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),
  • 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).

Primary outcome measures

  • 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]
Secondary outcome measures (2)
  • Weekly incidence rate of acute respiratory infections caused by influenza viruses and SARS-CoV-2 seen in general practice [Time frame: Baseline]
  • Proportion of patients included vaccinated against influenza [Time frame: Baseline]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-only

Study locations

France · 1 center
  • IPLESP - UMR S 1136, N° BC 2908, Faculté de médecine Sorbonne Université, site Saint Antoi — Paris

Identifiers

NCT: NCT07599449 · C21-62

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗