Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:58 AM
Ignite Modification Date:
2025-12-25 @ 4:58 AM
NCT ID:
NCT06282718
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Patients will not be eligible for if they have withdrawn their consent for anonymous data collection for research by their health care facility.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.
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT06282718
Study Brief:
Protocol Section:
NCT06282718