Observational study on acute respiratory infections in primary care across Europe

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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Patients will not be eligible for if they have withdrawn their consent for anonymous data collection for research by their health care facility.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

• 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
• Email: christopher.butler@phc.ox.ac.uk
• Phone: +44 (0)1865 289670

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• CRP point-of-care testing to guide antibiotic use for adults with respiratory symptoms in eight Jakarta primary care centers

  This trial tests whether using a C-reactive protein point-of-care test can help doctors in Jakarta decide when antibiotics are needed for adults with acute respiratory infections.

  Recruiting at 7 sites Oxford University Clinical Research Unit Indonesia · Jakarta and 7 other locations · NCT07717372

• Observational study of acute respiratory infections in adults

  This study looks at how adults with acute respiratory infections are treated in hospitals across Europe to see what works best and improve patient care.

  Recruiting at 11 sites European Clinical Research Alliance for Infectious Diseases (ECRAID) · Antwerp and 26 other locations · NCT05814237

• Evaluating treatments for severe community-acquired pneumonia in ICU patients

  This study tests different treatment options for ICU patients with severe pneumonia to see which ones work best, including special strategies for those with COVID-19.

  Recruiting at 234 sites Phase 3 UMC Utrecht · Jacksonville, Florida and 407 other locations · NCT02735707

• V175 and V175A vaccines in healthy adults

  This study tests two RSV vaccines (V175 and V175A) in healthy adults to see if they are safe and well tolerated.

  Recruiting at 2 sites Phase 1 Merck Sharp & Dohme LLC · Brisbane, Queensland and 1 other locations · NCT07855510

• Reducing unnecessary antibiotic use in children with respiratory infections

  This study is testing whether using a new support system in hospitals can help reduce unnecessary antibiotic prescriptions for kids with respiratory infections like pneumonia and bronchiolitis.

  Recruiting Vanderbilt University Medical Center · Oakland, California and 2 other locations · NCT06788093

• Using MeMed BV to help manage lower respiratory infections in emergency settings

  This study is testing if the MeMed BV test can help doctors decide when to use antibiotics for adults with lower respiratory infections in emergency settings.

  Recruiting at 6 sites MeMed Diagnostics Ltd. · Jacksonville, Florida and 9 other locations · NCT05762302

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.