RecruitingNCT06282718

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

Perpetual Observational Study (POS) of Acute Respiratory Infections (ARI) in Primary Care Settings (PC) Across Europe

Sponsor

European Clinical Research Alliance for Infectious Diseases (ECRAID)

Enrollment

2,000 participants

Start Date

Feb 22, 2024

Study Type

OBSERVATIONAL

Conditions

Acute Respiratory Tract Infection

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

Inclusion Criteria10

POS-ARI-PC AUDIT:
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.
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 Criteria11

Patients will not be eligible for if they have withdrawn their consent for anonymous data collection for research by their health care facility.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:
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
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.

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