POS-ARI-ER Observational Study of Acute Respiratory Infections
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Data collection.
- Who it may be relevant to
- Registry conditions: Acute Respiratory Infection, Acute Respiratory Tract Infection. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Belgium, Croatia, France, Greece, Italy +5
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Perpetual Observational Study of Acute Respiratory Infections Presenting Via Emergency Rooms and Other Acute Hospital Care Settings
Overview
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.
Interventions
- Other Data collection
Data collection from study participants to characterise diagnostic and therapeutic practices.
Primary outcome measures
- Proportion of adult patients undergoing ARI-relevant microbiology and virology investigations. [Time frame: Four years]
- Proportion of adult patients receiving antibiotics, antivirals, antifungals and/or immunomodulators. [Time frame: Four years]
- Clinical outcome of adults with community acquired ARI in acute hospital settings in Europe. [Time frame: Last day in hospital, at death or 28 days after admission, whichever comes first.]
- Length of hospital and/or ICU stay in adults with community acquired ARI in acute hospital settings in Europe. [Time frame: Last day in hospital, at death or 28 days after admission, whichever comes first.]
- Duration of NIV and IMV/ECMO in adults with community acquired ARI in acute hospital settings in Europe. [Time frame: Last day in hospital, at death or 28 days after admission, whichever comes first.]
- All cause mortality in adults with community acquired ARI in acute hospital settings in Europe. [Time frame: Last day in hospital, at death or 28 days after admission, whichever comes first.]
Secondary outcome measures (5)
- Patient demographics of the adult patient population with ARI presenting to acute hospital settings in Europe. [Time frame: Four years]
- Comorbidities in the adult patient population with ARI presenting to acute hospital settings in Europe. [Time frame: Four years]
- Presenting symptoms in the adult patient population with ARI presenting to acute hospital settings in Europe. [Time frame: Four years]
- Physiological measurements in the adult patient population with ARI presenting to acute hospital settings in Europe. [Time frame: Four years]
- Aetiology of ARI in adults presenting to acute hospital settings in Europe. [Time frame: Four years]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United Kingdom · 7 centers
- Craigavon Area Hospital — Craigavon
- NHS Lothian- Royal Infirmary of Edinburgh and St Johns Hospital — Edinburgh
- Gateshead Health NHS Foundation Trust — Gateshead
- Liverpool University Hospitals NHS Foundation Trust — Liverpool
- Royal Free London NHS Foundation Trust - Royal Free Hospital — London
- Sheffield Teaching Hospitals NSH Foundation Trust — Sheffield
- South Tyneside and Sunderland NHS Foundation — Sunderland
France · 4 centers
- CHU Grenoble — Grenoble
- CHU Limoges — Limoges
- CHU Lyon — Lyon
- CHU de Tours — Tours
Romania · 3 centers
- Agrippa Ionescu Hospital, Carol Davila University of Medicine and Pharmacy Bucharest — Bucharest
- Infectious and Tropical Diseases Hospital "Dr. Victor Babes" — Bucharest
- Cluj Napoca Infectious Disease Clinical Hospital — Cluj-Napoca
Netherlands · 2 centers
- Noordwest Ziekenhuisgroep — Alkmaar
- Radboud University Medical Center — Nijmegen
Spain · 2 centers
- Hospital General Universitario de Alicante — Alicante
- Hospital Universitario Virgen Macarena — Seville
Belgium · 1 center
- Erasme Hospital — Brussels
Croatia · 1 center
- University Hospital for Infectious Diseases, Zagreb — Zagreb
Greece · 1 center
- General University Hospital of Patras — Pátrai
Italy · 1 center
- Azienda Ospedaliera Policlinico di Bari — Bari
Serbia · 1 center
- General Hospital, Kragujevac — Kragujevac
Identifiers
NCT: NCT05814237 · ECRAID-Base POS-ARI-ER