Respiratory Tract Infections (RTI)RS-viro IRANCT07599449
Virological Surveillance of Acute Respiratory Infection in Primary Health Care in Metropolitan France
An observational study of Respiratory Tract Infections (RTI) and Influenza -Like Illness, run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site in France.
Trial 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). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Respiratory Tract Infections (RTI), Influenza -Like Illness, Influenza
- What is being tested?
- saliva sampling and Nasopharyngeal swab
- How many people
- 25,000 participants
- Where
- 1 siteFrance
- Study dates
- 14 May 2026to 14 May 2031
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients seen in GPs' consultation with an acute respiratory infection
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Olivier STEICHEN, MD, PhD contact
France1 site, 1 recruiting
- Recruiting
IPLESP - UMR S 1136, N° BC 2908, Faculté de médecine Sorbonne Université, site Saint Antoine, 27 rue Chaligny
Paris
Thierry BLANCHON, +33 1 44 73 84 35, thierry.blanchon@upmc.fr
Thierry BLANCHON
About this study
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.
- Conditions
- Respiratory Tract Infections (RTI), Influenza -Like Illness, Influenza, COVID - 19, RSV Infections, Rhinovirus Infection
- Being tested
- saliva sampling, Nasopharyngeal swab
- Medical subject headings
- Respiratory Tract Infections, Influenza, Human, COVID-19, Respiratory Syncytial Virus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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).
| Study group | Role | What they receive |
|---|---|---|
| Individuals with an ARI consulting a GP or a private pediatrician in mainland France | Not described Receives: Diagnostic Test: saliva sampling; Diagnostic Test: Nasopharyngeal swab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline
Secondary outcomes (2)
Weekly incidence rate of acute respiratory infections caused by influenza viruses and SARS-CoV-2 seen in general practice
Measured: Baseline
Proportion of patients included vaccinated against influenza
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2026
- Study start14 May 2026
- Primary completion14 May 2031 (estimated)
- Study completion14 May 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Tract Infections (RTI)Studies of the same condition, open and under way.
- More trials run by Institut National de la Santé Et de la Recherche Médicale, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 25,000 participants (estimated)
Sponsor and investigators
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Thierry BLANCHON, MD, PhD, Principal investigator, Institut National de la Santé Et de la Recherche Médicale, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07599449
- Sponsor's protocol ID
- C21-62
- Acronym
- RS-viro IRA
- Status last verified
- Jul 2026
- First submitted
- 6 May 2026
- Last updated
- 3 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No