A Long-term Observational Study Evaluating the Presentation and Management of Acute Respiratory Tract Infections in Primary Care Across Europe

NCT06282718 | Recruiting

• 5 other identifiers: POS-ARI-PC CORE and AUDIT9653131020412655487324504
• Study Type: observational
• Target: 2,000
• Locations: 3 countries
• Sites: 3

Brief 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.

Conditions

Acute Respiratory Tract Infection

Outcome Measures

Primary Outcomes (13)

• Age Bands

  Participant age recorded at baseline by site study team.

  Baseline (Day 0)

• The proportion with a preliminary diagnosis of various sub-categories of ARI (e.g. LRTI, URTI)

  Working diagnosis recorded at baseline by site study team.

  Baseline (Day 0)

• Overall illness severity rating

  Overall illness severity (clinician's impression) recorded at baseline (mild, moderate or severe) by site study team.

  Baseline (Day 0)

• Swab samples taken and retrospective viral/microbiological infection analysis performed (multiplex PCR) to identify potential causative pathogens.

  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.

  Baseline (Day 0)

• Proportion undergoing POC (with results) and lab-based investigations

  POC investigations recorded at baseline and results recorded at day 28 by site study team.

  Baseline (Day 0) and day 28.

• Details of prescriptions given on presentation of ARI

  Prescriptions given at presentation recorded at Baseline by site study team.

  Baseline (Day 0)

• Details of tests ordered on presentation of ARI

  Tests ordered at presentation recorded at Baseline by site study team.

  Baseline (Day 0)

• Return to usual daily activities

  Participants asked if they have returned to usual activities in daily diary.

  Day 1-14

• Feeling recovered from RTI

  Participants asked if they are feeling recovered from RTI in daily diary.

  Day 1-14

• Use of prescription medication

  Participants asked if they have used prescription medication for the RTI in daily diary.

  Day 1-14

• Use of over the counter medications

  Participants asked if they have used over the counter medication for the RTI in daily diary.

  Day 1-14

• Complications reported associated to ARI presentation

  Recorded at day 28 by a member of the site study team.

  Day 28

• Variation in practice and advice from national guidelines, to be fed back to national teams

  Practice and advise recorded at Baseline by site study team.

  Baseline (Day 0)

Secondary Outcomes (4)

• Recommendations on how to improve study processes, recruitment and study communication based on shared understanding and insights from researchers, clinicians, and patients.

  After day 28

• An understanding of the meaning of study results for European primary care, from the perspectives of clinicians and patients, and recommendations regarding the implementation of findings.

  After day 28

• An understanding of changing health-seeking behaviour, management and expectations to inform clinical studies and trials

  After day 28

• Approval for a study-specific appendix (SSA) or an intervention-specific appendix (ISA) of an embedded (non) randomised study for ARI in primary care associated with this POS, measured using the number of embedded studies to this POS-ARI-PC platform over

  Through study completion

Study Arms (1)

POS-ARI-PC

POS-ARI-PC AUDIT: Anonymous registration of patients of any age presenting at the participating primary care facility with ARI. POS-ARI-PC CORE: Patients of any age presenting at the participating primary care facility with ARI. POS-ARI-PC-001: Patients 60 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, presenting at the participating primary care facility with ARI.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients of any age group presenting to primary care settings with an ARI.

You may qualify if:

• 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.

You may not qualify if:

• 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:
• 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
• 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
• 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.
• 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.

Sponsors & Collaborators

• European Clinical Research Alliance for Infectious Diseases (ECRAID): lead
• UMC Utrecht: collaborator
• University of Oxford: collaborator
• Universiteit Antwerpen: collaborator

Study Sites (3)

Universiteit Antwerpen

Antwerp, Belgium

RECRUITING

Centre Hospitalier Universitaire de Limoges

Limoges, France

RECRUITING

University of Oxford

Oxford, United Kingdom

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

A combined throat/nose swab sample.

Central Study Contacts

Christopher Butler

CONTACT

+44 (0)1865 289670; christopher.butler@phc.ox.ac.uk

Nguyen Tran

CONTACT

ecraid-base@phc.ox.ac.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2024
• First Posted: February 28, 2024
• Study Start: February 22, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: April 14, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1); GB (1); BE (1)