POS-ARI-ER Observational Study of Acute Respiratory Infections
NCT ID: NCT05814237
Last Updated: 2024-09-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
11750 participants
OBSERVATIONAL
2023-06-20
2026-02-28
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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Data collection
Data collection from study participants to characterise diagnostic and therapeutic practices.
Eligibility Criteria
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Inclusion Criteria
* 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 admitted to hospital for \>2 days at the time of enrolment
* Patient has been previously enrolled in the POS-ARI-ER study
18 Years
ALL
No
Sponsors
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UMC Utrecht
OTHER
University of Oxford
OTHER
European Clinical Research Alliance for Infectious Diseases (ECRAID)
OTHER
Responsible Party
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Locations
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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
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
Seville, , 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
Countries
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Central Contacts
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Other Identifiers
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ECRAID-Base POS-ARI-ER
Identifier Type: -
Identifier Source: org_study_id
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