POS-ARI-ER Observational Study of Acute Respiratory Infections

NCT ID: NCT05814237

Last Updated: 2024-09-19

Study Results

Results pending

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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Recruitment Status

RECRUITING

Total Enrollment

11750 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-06-20

Study Completion Date

2026-02-28

Brief Summary

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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

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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.

Conditions

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Acute Respiratory Infection Acute Respiratory Tract Infection

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Data collection

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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UMC Utrecht

OTHER

Sponsor Role collaborator

University of Oxford

OTHER

Sponsor Role collaborator

European Clinical Research Alliance for Infectious Diseases (ECRAID)

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Erasme Hospital

Brussels, , Belgium

Site Status RECRUITING

University Hospital for Infectious Diseases, Zagreb

Zagreb, , Croatia

Site Status RECRUITING

CHU Grenoble

Grenoble, , France

Site Status RECRUITING

CHU Limoges

Limoges, , France

Site Status RECRUITING

CHU Lyon

Lyon, , France

Site Status RECRUITING

CHU de Tours

Tours, , France

Site Status RECRUITING

General University Hospital of Patras

Pátrai, , Greece

Site Status RECRUITING

Azienda Ospedaliera Policlinico di Bari

Bari, , Italy

Site Status RECRUITING

Noordwest Ziekenhuisgroep

Alkmaar, , Netherlands

Site Status RECRUITING

Radboud University Medical Center

Nijmegen, , Netherlands

Site Status RECRUITING

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

Bucharest, , Romania

Site Status RECRUITING

Infectious and Tropical Diseases Hospital "Dr. Victor Babes"

Bucharest, , Romania

Site Status RECRUITING

Cluj Napoca Infectious Disease Clinical Hospital

Cluj-Napoca, , Romania

Site Status RECRUITING

General Hospital, Kragujevac

Kragujevac, , Serbia

Site Status RECRUITING

Hospital General Universitario de Alicante

Alicante, , Spain

Site Status RECRUITING

Hospital Universitario Virgen Macarena

Seville, , Spain

Site Status RECRUITING

Craigavon Area Hospital

Craigavon, , United Kingdom

Site Status RECRUITING

NHS Lothian- Royal Infirmary of Edinburgh and St Johns Hospital

Edinburgh, , United Kingdom

Site Status RECRUITING

Gateshead Health NHS Foundation Trust

Gateshead, , United Kingdom

Site Status RECRUITING

Liverpool University Hospitals NHS Foundation Trust

Liverpool, , United Kingdom

Site Status RECRUITING

Royal Free London NHS Foundation Trust - Royal Free Hospital

London, , United Kingdom

Site Status RECRUITING

Sheffield Teaching Hospitals NSH Foundation Trust

Sheffield, , United Kingdom

Site Status RECRUITING

South Tyneside and Sunderland NHS Foundation

Sunderland, , United Kingdom

Site Status RECRUITING

Countries

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Belgium Croatia France Greece Italy Netherlands Romania Serbia Spain United Kingdom

Central Contacts

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Yrene Themistocleous

Role: CONTACT

01865 612979

Other Identifiers

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ECRAID-Base POS-ARI-ER

Identifier Type: -

Identifier Source: org_study_id

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