POS-ARI-ER Observational Study of Acute Respiratory Infections

Acute Respiratory Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05814237
• Other study ID #: ECRAID-Base POS-ARI-ER
• Status: Not yet recruiting
• Start date: April 24, 2023
• Est. completion date: February 28, 2026

Study information

• Verified date: April 2023
• Source: European Clinical Research Alliance for Infectious Diseases (ECRAID)
• Contact: Yrene Themistocleous
• Phone: 01865 612979
• Email: pos-ari-er[@]ndm.ox.ac.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 11750
• Est. completion date: February 28, 2026
• Est. primary completion date: February 28, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Respiratory Infection
• Acute Respiratory Tract Infection
• Communicable Diseases
• Infections
• Respiratory Tract Infections

Intervention

Other:
• Data collection
Data collection from study participants to characterise diagnostic and therapeutic practices.

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
European Clinical Research Alliance for Infectious Diseases (ECRAID)	UMC Utrecht, University of Oxford

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.
Primary	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
Primary	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
Primary	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.
Primary	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.
Primary	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.
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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