Ignite Creation Date:
2025-12-25 @ 4:58 AM
Ignite Modification Date:
2025-12-26 @ 3:59 AM
Study NCT ID:
NCT06282718
Status:
RECRUITING
Last Update Posted:
2024-10-18
First Post:
2024-01-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Long-term Observational Study Evaluating the Presentation and Management of Acute Respiratory Tract Infections in Primary Care Across Europe
Sponsor:
European Clinical Research Alliance for Infectious Diseases (ECRAID)
Organization:
Study Overview
Official Title:
Perpetual Observational Study (POS) of Acute Respiratory Infections (ARI) in Primary Care Settings (PC) Across Europe
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
POS-ARI-PC
Brief Summary:
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.
Detailed Description:
The main aim for POS-ARI-PC is to provide a platform for continuous data capture for patients with ARI presenting to primary care settings across Europe, covering cases caused by known and emerging respiratory pathogens with epidemic and pandemic potential, in order to generate observational evidence to inform care and maintain study- readiness for RCT evaluations. The POS-ARI-PC platform will thereby support the efficient set-up of new clinical studies and trials, which will be embedded into the platform.
We have developed two overarching protocols for the POS-ARI-PC. The POS-ARI-PC AUDIT protocol allows for a flexible annual anonymous prospective audit-type registration to describe the presentation and management of patients presenting in primary care with ARI. This provides the infrastructure for patient sampling and follow-up, and in which randomisation can be activated for platform trials to evaluate a range of interventions that can be added and replaced over time. This has resulted in the POS-ARI-PC CORE protocol.
POS-ARI-PC AUDIT:
This is a flexible annual anonymous prospective audit-type registration to describe the presentation and management of patients presenting in primary care with ARI. POS-ARI-PC AUDIT will be delivered through a prospective, multi-country, audit-type anonymous registration of presentation and management of approximately 2,000 patients presenting to PC annually across Europe. This audit will benchmark the case mix and care of patients consulting in PC. These can include general practice, urgent care centres, accident and emergency and other acute services in hospitals, for adult and paediatric patients, both in and out of office hours.
POS-ARI-PC CORE:
This is a non-randomised, prospective, observational study of the presentation, management, microbiology and outcome of acute respiratory tract infection in primary care.
POS-ARI-PC CORE has the following three objectives:
Objective 1. A prospective, observational study of ARI patients in primary care to undergo study-specific sampling upon inclusion and be followed up for 28 days to capture the aetiology of their ARI and describe clinical outcomes.
Objective 2. A qualitative study with research professionals, clinicians, and patients to a) gain a deep understanding of the research process, and the meaning of results and to identify barriers and opportunities for implementation of changes considering findings, and b) explore the views and experiences of patients who consult European primary care services for ARI symptoms since the COVID-19 pandemic.
Objectives 3. 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. When a new embedded observational study or RCT is added to the POS-ARI-PC a study-specific appendix (SSA) or an intervention-specific appendix (ISA) will be developed which details the (changes in) the study population, the research question, objectives, outcomes, study-specific processes and analysis. This will be appended to the POS-ARI-PC CORE Protocol and all appropriate approvals will be gained for each SSA or ISA.
Participation in the study will last for 28 days. Once consented to the study, a member of the study team will complete a short questionnaire collecting the participants' names and contact information, some details about them, and the symptoms they have been experiencing. A combined throat/nose swab will be collected from the patient for study purposes.
Participants will also be asked to tell us about how they are feeling today and for the next 14 days via an online or paper daily diary. They might be telephoned to ask some questions if they are unable to complete the daily diary. Their GP will be contacted after day 28 to collect information about their consultations and hospital referrals in the 28-day period.
A small number of enrolled participants who consented (optional) to be contacted by the research team about the nested qualitative study will be invited for a process evaluation interview.
POS-ARI-PC-001:
The first embedded study, POS-ARI-PC-001, will be conducted as a prospective observational study to estimate the incidence of medically-attended RSV, HMPV, HPIV and RV infections in an elderly population. This embedded study is appended to the POS-ARI-PC CORE Protocol as a study specific appendix (SSA).
We have developed two overarching protocols for the POS-ARI-PC. The POS-ARI-PC AUDIT protocol allows for a flexible annual anonymous prospective audit-type registration to describe the presentation and management of patients presenting in primary care with ARI. This provides the infrastructure for patient sampling and follow-up, and in which randomisation can be activated for platform trials to evaluate a range of interventions that can be added and replaced over time. This has resulted in the POS-ARI-PC CORE protocol.
POS-ARI-PC AUDIT:
This is a flexible annual anonymous prospective audit-type registration to describe the presentation and management of patients presenting in primary care with ARI. POS-ARI-PC AUDIT will be delivered through a prospective, multi-country, audit-type anonymous registration of presentation and management of approximately 2,000 patients presenting to PC annually across Europe. This audit will benchmark the case mix and care of patients consulting in PC. These can include general practice, urgent care centres, accident and emergency and other acute services in hospitals, for adult and paediatric patients, both in and out of office hours.
POS-ARI-PC CORE:
This is a non-randomised, prospective, observational study of the presentation, management, microbiology and outcome of acute respiratory tract infection in primary care.
POS-ARI-PC CORE has the following three objectives:
Objective 1. A prospective, observational study of ARI patients in primary care to undergo study-specific sampling upon inclusion and be followed up for 28 days to capture the aetiology of their ARI and describe clinical outcomes.
Objective 2. A qualitative study with research professionals, clinicians, and patients to a) gain a deep understanding of the research process, and the meaning of results and to identify barriers and opportunities for implementation of changes considering findings, and b) explore the views and experiences of patients who consult European primary care services for ARI symptoms since the COVID-19 pandemic.
Objectives 3. 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. When a new embedded observational study or RCT is added to the POS-ARI-PC a study-specific appendix (SSA) or an intervention-specific appendix (ISA) will be developed which details the (changes in) the study population, the research question, objectives, outcomes, study-specific processes and analysis. This will be appended to the POS-ARI-PC CORE Protocol and all appropriate approvals will be gained for each SSA or ISA.
Participation in the study will last for 28 days. Once consented to the study, a member of the study team will complete a short questionnaire collecting the participants' names and contact information, some details about them, and the symptoms they have been experiencing. A combined throat/nose swab will be collected from the patient for study purposes.
Participants will also be asked to tell us about how they are feeling today and for the next 14 days via an online or paper daily diary. They might be telephoned to ask some questions if they are unable to complete the daily diary. Their GP will be contacted after day 28 to collect information about their consultations and hospital referrals in the 28-day period.
A small number of enrolled participants who consented (optional) to be contacted by the research team about the nested qualitative study will be invited for a process evaluation interview.
POS-ARI-PC-001:
The first embedded study, POS-ARI-PC-001, will be conducted as a prospective observational study to estimate the incidence of medically-attended RSV, HMPV, HPIV and RV infections in an elderly population. This embedded study is appended to the POS-ARI-PC CORE Protocol as a study specific appendix (SSA).
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: