POS-ARI-ER Observational Study of Acute Respiratory Infections
- Conditions
- Acute Respiratory InfectionAcute Respiratory Tract Infection
- Registration Number
- NCT05814237
- Lead Sponsor
- European Clinical Research Alliance for Infectious Diseases (ECRAID)
- Brief 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.
- 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 11750
- 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
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of adult patients receiving antibiotics, antivirals, antifungals and/or immunomodulators. Four years Calculate the proportion of cases receiving antibiotics, antivirals, antifungals and/or immunomodulators.
All cause mortality in adults with community acquired ARI in acute hospital settings in Europe. Last day in hospital, at death or 28 days after admission, whichever comes first. Total number of deaths for each ARI-related pathogen.
Duration of NIV and IMV/ECMO in adults with community acquired ARI in acute hospital settings in Europe. Last day in hospital, at death or 28 days after admission, whichever comes first. Number of days patients receiving NIV and IMV/ECMO.
Proportion of adult patients undergoing ARI-relevant microbiology and virology investigations. Four years Calculate the proportion of types of ARI-relevant microbiology and virology investigations performed.
Length of hospital and/or ICU stay in adults with community acquired ARI in acute hospital settings in Europe. Last day in hospital, at death or 28 days after admission, whichever comes first. Number of days patient admitted to hospital or ICU.
Clinical outcome of adults with community acquired ARI in acute hospital settings in Europe. Last day in hospital, at death or 28 days after admission, whichever comes first. 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.
- Secondary Outcome Measures
Name Time Method Aetiology of ARI in adults presenting to acute hospital settings in Europe. Four years 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).
Presenting symptoms in the adult patient population with ARI presenting to acute hospital settings in Europe. Four years Evaluation of presenting symptoms in the adult patient population with ARI.
Physiological measurements in the adult patient population with ARI presenting to acute hospital settings in Europe. Four years Evaluation of the physiological measurements in the adult patient population with ARI.
Patient demographics of the adult patient population with ARI presenting to acute hospital settings in Europe. Four years Evaluate demographics of patient population with ARI.
Comorbidities in the adult patient population with ARI presenting to acute hospital settings in Europe. Four years Evaluation of comorbidities in patient population with ARI.
Trial Locations
- Locations (23)
Erasme Hospital
🇧🇪Brussels, Belgium
University Hospital for Infectious Diseases, Zagreb
🇭🇷Zagreb, Croatia
CHU Grenoble
🇫🇷Grenoble, France
CHU Limoges
🇫🇷Limoges, France
CHU Lyon
🇫🇷Lyon, France
CHU de Tours
🇫🇷Tours, France
General University Hospital of Patras
🇬🇷Patras, Greece
Azienda Ospedaliera Policlinico di Bari
🇮🇹Bari, Italy
Noordwest Ziekenhuisgroep
🇳🇱Alkmaar, Netherlands
Radboud University Medical Center
🇳🇱Nijmegen, Netherlands
Agrippa Ionescu Hospital, Carol Davila University of Medicine and Pharmacy Bucharest
🇷🇴Bucharest, Romania
Infectious and Tropical Diseases Hospital "Dr. Victor Babes"
🇷🇴Bucharest, Romania
Cluj Napoca Infectious Disease Clinical Hospital
🇷🇴Cluj Napoca, Romania
General Hospital, Kragujevac
🇷🇸Kragujevac, Serbia
Hospital General Universitario de Alicante
🇪🇸Alicante, Spain
Hospital Universitario Virgen Macarena
🇪🇸Sevilla, Spain
Craigavon Area Hospital
🇬🇧Craigavon, United Kingdom
NHS Lothian- Royal Infirmary of Edinburgh and St Johns Hospital
🇬🇧Edinburgh, United Kingdom
Gateshead Health NHS Foundation Trust
🇬🇧Gateshead, United Kingdom
Liverpool University Hospitals NHS Foundation Trust
🇬🇧Liverpool, United Kingdom
Royal Free London NHS Foundation Trust - Royal Free Hospital
🇬🇧London, United Kingdom
Sheffield Teaching Hospitals NSH Foundation Trust
🇬🇧Sheffield, United Kingdom
South Tyneside and Sunderland NHS Foundation
🇬🇧Sunderland, United Kingdom