POS-ARI-ER Observational Study of Acute Respiratory Infections

Perpetual Observational Study of Acute Respiratory Infections Presenting Via Emergency Rooms and Other Acute Hospital Care Settings

Acute respiratory infections (ARI) are one of the most frequent reasons for hospital admission and antibiotic use, and can be caused by a broad range of pathogens, including respiratory viruses with proven epidemic potential, e.g. influenza and coronaviruses. The POS-ARI-ER study will focus on describing the different routine diagnostic and therapeutic practices in the work-up and treatment of ARI, as well as clinical outcomes across the patient population. In addition, POS-ARI-ER aims to characterise both the adult patient population with ARI presenting to acute hospital settings in Europe, and the aetiology of ARI in these patients.

Study Overview

• Status: Not yet recruiting
• Conditions: Acute Respiratory Infection; Acute Respiratory Tract Infection
• Intervention / Treatment: Other: Data collection

Detailed Description

The POS-ARI-ER study is a perpetual, observational study (POS), designed to provide data for clinical characterisation of acute respiratory infections (ARIs) in adults presenting to hospital settings across Europe.

Establishing the etiological cause of ARI at the time of presentation is difficult with currently available diagnostic approaches. Improvements in diagnosis and strategies for use of targeted antibiotic and antiviral treatment strategies are needed to improve patient outcomes, and to reduce selection of antimicrobial resistance (AMR) and antiviral resistance. Recent advances in routine diagnostics in secondary care settings include molecular tests that can detect multiple pathogens simultaneously, and highly sensitive and specific point of care tests that can provide attending clinicians with rapid results. However, the implementation of these technologies into routine clinical practice within hospitals, and any impact on treatment decisions or patient outcomes, has not been widely evaluated.

The aim is to accurately characterise cases of ARIs presenting to acute hospital services, such as emergency departments and acute medical assessment units, in Europe.

Characterisation will focus on identifying the routine diagnostic methods (laboratory and point of care testing) and pharmacological interventions employed by different centres in patients presenting with ARI. Data will be collected using standardised report forms that capture clinical, laboratory and prescribing information. Participants will include those who require admission to hospital, as well as patients who are discharged the same day from the emergency department or acute medical assessment unit. In addition, a subset of participants will have single upper respiratory tract research sample (e.g. nose/throat swab) obtained at enrolment (within 24 hours), for pathogen detection by molecular methods.

Describing the variations in routine practice provides a foundation both to improve patient care through currently available approaches, as well as to inform areas of focus for development of new strategies.

• Study Type: Observational
• Enrollment (Anticipated): 11750

Contacts and Locations

• Study Contact: Name: Yrene Themistocleous; Phone Number: 01865 612979; Email: pos-ari-er@ndm.ox.ac.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult patients with community acquired acute respiratory infections presenting to acute hospital settings in Europe.

Description

Inclusion Criteria:

• Age ≥ 18 years
• Clinical suspicion of a new episode of acute respiratory tract infection, with onset in the last 10 days
• Patient presents to an emergency room or secondary care setting
• Informed consent is provided by patient or their legal representative

Exclusion Criteria:

• Patient has been transferred from another hospital
• Patient admitted to hospital for >2 days at the time of enrolment
• Patient has been previously enrolled in the POS-ARI-ER study

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of adult patients undergoing ARI-relevant microbiology and virology investigations.	Calculate the proportion of types of ARI-relevant microbiology and virology investigations performed.	Four years
Proportion of adult patients receiving antibiotics, antivirals, antifungals and/or immunomodulators.	Calculate the proportion of cases receiving antibiotics, antivirals, antifungals and/or immunomodulators.	Four years
Clinical outcome of adults with community acquired ARI in acute hospital settings in Europe.	Maximal score using the ordinal scale assessed at discharge, death or at 28 days after hospital admission: 6= death, 5= hospitalisation requiring extracorporeal membrane oxygenation (ECMO) and/or invasive mechanical ventilation, 4= hospitalisation requiring non invasive ventilation (NIV) and/or high flow nasal cannula (HFNC) oxygen therapy, 3= requiring supplemental oxygen (but not NIV/HFNC), 2= hospitalisation not requiring supplemental oxygen, 1= not hospitalised.	Last day in hospital, at death or 28 days after admission, whichever comes first.
Length of hospital and/or ICU stay in adults with community acquired ARI in acute hospital settings in Europe.	Number of days patient admitted to hospital or ICU.	Last day in hospital, at death or 28 days after admission, whichever comes first.
Duration of NIV and IMV/ECMO in adults with community acquired ARI in acute hospital settings in Europe.	Number of days patients receiving NIV and IMV/ECMO.	Last day in hospital, at death or 28 days after admission, whichever comes first.
All cause mortality in adults with community acquired ARI in acute hospital settings in Europe.	Total number of deaths for each ARI-related pathogen.	Last day in hospital, at death or 28 days after admission, whichever comes first.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient demographics of the adult patient population with ARI presenting to acute hospital settings in Europe.	Evaluate demographics of patient population with ARI.	Four years
Comorbidities in the adult patient population with ARI presenting to acute hospital settings in Europe.	Evaluation of comorbidities in patient population with ARI.	Four years
Presenting symptoms in the adult patient population with ARI presenting to acute hospital settings in Europe.	Evaluation of presenting symptoms in the adult patient population with ARI.	Four years
Physiological measurements in the adult patient population with ARI presenting to acute hospital settings in Europe.	Evaluation of the physiological measurements in the adult patient population with ARI.	Four years
Aetiology of ARI in adults presenting to acute hospital settings in Europe.	Detection of putative pathogens in respiratory tract samples (research upper respiratory tract sample at presentation and ARI-relevant microbiology/virology results obtained through routine clinical care).	Four years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Association between clinical outcomes and diagnostic or treatment related variables, for different aetiologies of community acquired ARI in adults presenting to hospital across Europe.	Maximal score on ordinal scale assessed at discharge, death or at 28 days after hospital admission: 6= death, 5= hospitalisation requiring extracorporeal membrane oxygenation (ECMO) and/or invasive mechanical ventilation, 4= hospitalisation requiring non invasive ventilation (NIV) and/or high flow nasal cannula (HFNC) oxygen therapy, 3= requiring supplemental oxygen (but not NIV/HFNC), 2= hospitalisation not requiring supplemental oxygen, 1= not hospitalised, stratified by pathogen.	Last day in hospital, at death or 28 days after admission, whichever comes first.

Collaborators and Investigators

• Sponsor: European Clinical Research Alliance for Infectious Diseases (ECRAID)
• Collaborators: UMC Utrecht; University of Oxford

Study record dates

Study Major Dates

• Study Start (Anticipated): April 24, 2023
• Primary Completion (Anticipated): February 28, 2026
• Study Completion (Anticipated): February 28, 2026

Study Registration Dates

• First Submitted: February 27, 2023
• First Submitted That Met QC Criteria: April 13, 2023
• First Posted (Actual): April 14, 2023

Study Record Updates

• Last Update Posted (Actual): April 14, 2023
• Last Update Submitted That Met QC Criteria: April 13, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Infections; Communicable Diseases
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Disease Attributes; Infections; Communicable Diseases; Respiratory Tract Infections
• Other Study ID Numbers: ECRAID-Base POS-ARI-ER

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No