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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.
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
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
Pátrai, Greece
Azienda Ospedaliera Policlinico di Bari
Bari, Italy
Noordwest Ziekenhuisgroep
Alkmaar, Netherlands
Radboud University Medical Center
Nijmegen, Netherlands
Start Date
June 20, 2023
Primary Completion Date
February 28, 2026
Completion Date
February 28, 2026
Last Updated
September 19, 2024
11,750
ESTIMATED participants
Data collection
OTHER
Lead Sponsor
European Clinical Research Alliance for Infectious Diseases (ECRAID)
Collaborators
NCT07396428
NCT07278700
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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