POS-ARI-ER Observational Study of Acute Respiratory Infections

Last updated: September 2, 2024
Sponsor: European Clinical Research Alliance for Infectious Diseases (ECRAID)
Overall Status: Active - Recruiting

Phase

N/A

Condition

Respiratory Syncytial Virus (Rsv) Infection

Covid-19

Common Cold

Treatment

Data collection

Clinical Study ID

NCT05814237
ECRAID-Base POS-ARI-ER
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age ≥ 18 years

  • Clinical suspicion of a new episode of acute respiratory tract infection, with onsetin 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

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 Design

Total Participants: 11750
Treatment Group(s): 1
Primary Treatment: Data collection
Phase:
Study Start date:
June 20, 2023
Estimated Completion Date:
February 28, 2026

Study 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.

Connect with a study center

  • Erasme Hospital

    Brussels,
    Belgium

    Active - Recruiting

  • University Hospital for Infectious Diseases, Zagreb

    Zagreb,
    Croatia

    Active - Recruiting

  • CHU Grenoble

    Grenoble,
    France

    Active - Recruiting

  • CHU Limoges

    Limoges,
    France

    Active - Recruiting

  • CHU Lyon

    Lyon,
    France

    Active - Recruiting

  • CHU de Tours

    Tours,
    France

    Active - Recruiting

  • General University Hospital of Patras

    Patras,
    Greece

    Active - Recruiting

  • Azienda Ospedaliera Policlinico di Bari

    Bari,
    Italy

    Active - Recruiting

  • Noordwest Ziekenhuisgroep

    Alkmaar,
    Netherlands

    Active - Recruiting

  • Radboud University Medical Center

    Nijmegen,
    Netherlands

    Active - Recruiting

  • Agrippa Ionescu Hospital, Carol Davila University of Medicine and Pharmacy Bucharest

    Bucharest,
    Romania

    Active - Recruiting

  • Infectious and Tropical Diseases Hospital "Dr. Victor Babes"

    Bucharest,
    Romania

    Active - Recruiting

  • Cluj Napoca Infectious Disease Clinical Hospital

    Cluj Napoca,
    Romania

    Active - Recruiting

  • General Hospital, Kragujevac

    Kragujevac,
    Serbia

    Active - Recruiting

  • Hospital General Universitario de Alicante

    Alicante,
    Spain

    Active - Recruiting

  • Hospital Universitario Virgen Macarena

    Sevilla,
    Spain

    Active - Recruiting

  • Craigavon Area Hospital

    Craigavon,
    United Kingdom

    Active - Recruiting

  • NHS Lothian- Royal Infirmary of Edinburgh and St Johns Hospital

    Edinburgh,
    United Kingdom

    Active - Recruiting

  • Gateshead Health NHS Foundation Trust

    Gateshead,
    United Kingdom

    Active - Recruiting

  • Liverpool University Hospitals NHS Foundation Trust

    Liverpool,
    United Kingdom

    Active - Recruiting

  • Royal Free London NHS Foundation Trust - Royal Free Hospital

    London,
    United Kingdom

    Active - Recruiting

  • Sheffield Teaching Hospitals NSH Foundation Trust

    Sheffield,
    United Kingdom

    Active - Recruiting

  • South Tyneside and Sunderland NHS Foundation

    Sunderland,
    United Kingdom

    Active - Recruiting

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