Clinical Trials in France / NCT06282718
Recruiting
Observational
A Long-term Observational Study Evaluating the Presentation and Management of Acute Respiratory Tract Infections in Primary Care Across Europe
NCT06282718 · tracked via the Priya Life Science France tracker
Condition(s) studied
Acute Respiratory Tract Infection
Study summary
Acute respiratory infection (ARI) is the commonest reason for consulting in community care. Furthermore, new and re-emerging pathogens are often first noticed in primary care (PC). The POS-ARI-PC study is a long-term study, with the aim of describing the nature of ARI in adults and children presenting to PC across Europe. The POS-ARI-PC study will provide critically important data on the presentation and management of ARI, and build a research-ready infrastructure for studies related to the treatment, diagnosis, and prevention of ARI in primary care settings. Additional observational studies will be embedded and use the infrastructure developed in POS-ARI-PC.
Eligibility
POS-ARI-PC AUDIT:
Inclusion Criteria:
Eligible patients will be of any age consulting (telephone, video, face-to-face) with a participating health care facility with:
* Symptoms suggestive of an acute lower RTI with cough as predominant symptom and with illness duration less than 28 days, AND/OR
* Symptoms suggestive of an acute upper RTI with sore throat and/or coryza as predominant symptom and with illness duration of less than 14 days AND/OR
* Patients otherwise suspected of COVID-19, influenza or RSV.
Exclusion Criteria:
Patients will not be eligible for if they have withdrawn their consent for anonymous data collection for research by their health care facility.
POS-ARI-PC CORE:
Inclusion criteria:
Eligible patients will be of any age consulting (telephone, video, face to face) with a participating primary health care facility with:
* Symptoms suggestive of an acute lower respiratory infection with cough as the predominant symptom, with illness duration less than 28 days, AND/OR
* Symptoms suggestive of an acute upper respiratory infection with sore throat and/or coryza as the predominant symptom, with illness duration of less than 14 days AND/OR
* Other symptoms suggestive of COVID-19, Influenza, RSV AND
* Participant or legal guardian(s) willing and able to provide informed consent and comply with study procedures
Exclusion criteria:
Patients will not be eligible if:
* According to the judgement of the recruiting clinician, they will not be able comply with study procedures, for example because they do not understand the language in which the study is being conducted locally (and have no one to help and translate for them); have a serious psychiatric disorder; or are terminally ill
* Symptoms of presumed non-infective origin
* Participant requires admission to hospital on the day of inclusion
Additional in/exclusion criteria might apply to embedded studies and will be described in the SSA or ISA.
POS-ARI-PC-001:
Symptoms and Duration Symptoms suggestive of an acute lower RTI with new or increased cough as the predominant symptom, with illness duration ≤10 days; AND/OR Symptoms suggestive of an acute upper RTI with sore throat and/or coryza as the predominant symptom, with illness duration ≤10 days;
Age Aged 60 years and over OR Aged 50 to 59 years and have a long-term health condition which makes them eligible for the yearly influenza vaccination under the national influenza vaccination programme;
Consent Willing and able to provide informed consent and have a swab taken.
Exclusion Criteria:
As per the POS-ARI-PC CORE Protocol, with one exception: patients needing hospitalisation can be recruited into the study if timing allows. Patients can provide a swab and decide not to participate in the follow-up procedures.
Primary outcome measure(s)
- Age Bands — Baseline (Day 0)
Participant age recorded at baseline by site study team. - The proportion with a preliminary diagnosis of various sub-categories of ARI (e.g. LRTI, URTI) — Baseline (Day 0)
Working diagnosis recorded at baseline by site study team. - Overall illness severity rating — Baseline (Day 0)
Overall illness severity (clinician's impression) recorded at baseline (mild, moderate or severe) by site study team. - Swab samples taken and retrospective viral/microbiological infection analysis performed (multiplex PCR) to identify potential causative pathogens. — Baseline (Day 0)
Participants have a combined oropharyngeal and nasal swab taken at the baseline visit which will be subjected to PCR-based analysis to identify potential causative pathogens. - Proportion undergoing POC (with results) and lab-based investigations — Baseline (Day 0) and day 28.
POC investigations recorded at baseline and results recorded at day 28 by site study team. - Details of prescriptions given on presentation of ARI — Baseline (Day 0)
Prescriptions given at presentation recorded at Baseline by site study team. - Details of tests ordered on presentation of ARI — Baseline (Day 0)
Tests ordered at presentation recorded at Baseline by site study team. - Return to usual daily activities — Day 1-14
Participants asked if they have returned to usual activities in daily diary. - Feeling recovered from RTI — Day 1-14
Participants asked if they are feeling recovered from RTI in daily diary. - Use of prescription medication — Day 1-14
Participants asked if they have used prescription medication for the RTI in daily diary. - Use of over the counter medications — Day 1-14
Participants asked if they have used over the counter medication for the RTI in daily diary. - Complications reported associated to ARI presentation — Day 28
Recorded at day 28 by a member of the site study team. - Variation in practice and advice from national guidelines, to be fed back to national teams — Baseline (Day 0)
Practice and advise recorded at Baseline by site study team.
Trial sites (3)
| Facility | City | Region | Status |
|---|---|---|---|
| Universiteit Antwerpen | Antwerp | Belgium | Recruiting |
| Centre Hospitalier Universitaire de Limoges | Limoges | France | Recruiting |
| University of Oxford | Oxford | United Kingdom | Recruiting |
More European Clinical Research Alliance for Infectious Diseases (ECRAID) trials in France
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06282718 on ClinicalTrials.gov ↗ ← All trials in France