A Long-term Observational Study Evaluating the Presentation and Management of Acute Respiratory Tract Infections in Primary Care Across Europe

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorEuropean Clinical Research Alliance for Infectious Diseases (ECRAID)

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

2,000 Participants
are grouped into 1 trial group
Group A: POS-ARI-PC

Trial outcomes

Primary outcomes

1

Age Bands

Participant age recorded at baseline by site study team.

Time frame
Baseline (Day 0)
2

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.

Time frame
Baseline (Day 0)
3

Overall illness severity rating

Overall illness severity (clinician's impression) recorded at baseline (mild, moderate or severe) by site study team.

Time frame
Baseline (Day 0)
4

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.

Time frame
Baseline (Day 0)

Secondary outcomes

1

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.

Time frame
After day 28
2

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.

Time frame
After day 28
3

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

Time frame
After day 28
4

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.

Time frame
Through study completion

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

European Clinical Research Alliance for Infectious Diseases (ECRAID)

Lead sponsor

UMC Utrecht

Collaborator

University of Oxford

Collaborator

Universiteit Antwerpen

Collaborator