About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial population
Patients of any age group presenting to primary care settings with an ARI.
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Age Bands
Participant age recorded at baseline by site study team.
The proportion with a preliminary diagnosis of various sub-categories of ARI (e.g. LRTI, URTI)
Working diagnosis recorded at baseline by site study team.
Overall illness severity rating
Overall illness severity (clinician's impression) recorded at baseline (mild, moderate or severe) by site study team.
Swab samples taken and retrospective viral/microbiological infection analysis performed (multiplex PCR) to identify potential causative pathogens.
Participants have a combined oropharyngeal and nasal swab taken at the baseline visit which will be subjected to PCR-based analysis to identify potential causative pathogens.
Secondary outcomes
Recommendations on how to improve study processes, recruitment and study communication based on shared understanding and insights from researchers, clinicians, and patients.
Using qualitative research methods, interviews conducted with research professionals, clinicians and patients to gain a deep understanding of the research process, meaning of results and to identify barriers and opportunities for implementation of findings. Capturing patients' views on their vulnerability towards ARI in the community since the COVID19 pandemic.
An understanding of the meaning of study results for European primary care, from the perspectives of clinicians and patients, and recommendations regarding the implementation of findings.
Using qualitative research methods, interviews conducted with research professionals, clinicians and patients to gain a deep understanding of the research process, meaning of results and to identify barriers and opportunities for implementation of findings. Capturing patients' views on their vulnerability towards ARI in the community since the COVID19 pandemic.
An understanding of changing health-seeking behaviour, management and expectations to inform clinical studies and trials
Measured using an interview conducted by the social science team after taking part in the main study and using a descriptive analysis
Approval for a study-specific appendix (SSA) or an intervention-specific appendix (ISA) of an embedded (non) randomised study for ARI in primary care associated with this POS, measured using the number of embedded studies to this POS-ARI-PC platform over
To ensure research readiness for including embedded observational and randomised evaluations to answer questions about the effectiveness of diagnostic, behavioural or therapeutic management strategies for ARI in PC.
Sponsors and contacts
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European Clinical Research Alliance for Infectious Diseases (ECRAID)
Lead sponsor
UMC Utrecht
Collaborator
University of Oxford
Collaborator
Universiteit Antwerpen
Collaborator