Status:
RECRUITING
A Long-term Observational Study Evaluating the Presentation and Management of Acute Respiratory Tract Infections in Primary Care Across Europe
Lead Sponsor:
European Clinical Research Alliance for Infectious Diseases (ECRAID)
Collaborating Sponsors:
UMC Utrecht
University of Oxford
Conditions:
Acute Respiratory Tract Infection
Eligibility:
All Genders
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 stud...
Detailed Description
The main aim for POS-ARI-PC is to provide a platform for continuous data capture for patients with ARI presenting to primary care settings across Europe, covering cases caused by known and emerging re...
Eligibility Criteria
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Patients will not be eligible for if they have withdrawn their consent for anonymous data collection for research by their health care facility.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.
Key Trial Info
Start Date :
February 22 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
July 1 2026
Estimated Enrollment :
2000 Patients enrolled
Trial Details
Trial ID
NCT06282718
Start Date
February 22 2024
End Date
July 1 2026
Last Update
April 14 2026
Active Locations (3)
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1
Universiteit Antwerpen
Antwerp, Belgium
2
Centre Hospitalier Universitaire de Limoges
Limoges, France
3
University of Oxford
Oxford, United Kingdom