Observational study on acute respiratory infections in primary care across Europe

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

This study looks at how acute respiratory infections are treated in adults and children visiting primary care in Europe to help improve care and support future research.

Quick facts

• Study type: Observational
• Enrollment: 2000 (estimated)
• Sex: All
• Sponsor: European Clinical Research Alliance for Infectious Diseases (ECRAID) (Academic / other)
• Locations: 3 sites (Antwerp and 2 other locations)
• Trial ID: NCT06282718 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the presentation and management of acute respiratory tract infections (ARI) in both adults and children attending primary care across Europe. It will create a platform for continuous data collection on ARI cases caused by known and emerging pathogens, facilitating the generation of observational evidence to inform clinical care. The study will also support the setup of new clinical studies and trials related to ARI management by embedding additional observational studies within its infrastructure. Approximately 2,000 patients will be registered annually to benchmark care and case mix.

Who should consider this trial

Good fit: Ideal candidates include individuals of any age presenting with symptoms suggestive of acute respiratory infections at participating healthcare facilities.

Not a fit: Patients who have withdrawn consent for anonymous data collection will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance the understanding and management of acute respiratory infections, leading to improved patient outcomes.

How similar studies have performed: Other studies have shown success in similar observational approaches, indicating the potential for valuable insights in ARI management.

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.

Where this trial is running

Antwerp and 2 other locations

• Universiteit Antwerpen — Antwerp, Belgium (Recruiting)
• Centre Hospitalier Universitaire de Limoges — Limoges, France (Recruiting)
• University of Oxford — Oxford, United Kingdom (Recruiting)

Study contacts

• Study coordinator: Christopher Butler

Conditions Acute Respiratory Tract Infection