Clinical trial NCT05814237: POS-ARI-ER Observational Study of Acute Respiratory Infections
Official title: Perpetual Observational Study of Acute Respiratory Infections Presenting Via Emergency Rooms and Other Acute Hospital Care Settings
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Acute Respiratory Infection
Acute Respiratory Tract Infection
Keywords: Infections
Communicable Diseases
Lead sponsor: European Clinical Research Alliance for Infectious Diseases (ECRAID)
Sponsor class: OTHER
Collaborators: name: UMC Utrecht
name: University of Oxford
First posted: 2023-04-14
Enrollment: 11750
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with community acquired acute respiratory infections presenting to acute hospital settings in Europe.

Brief 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.

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.

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

Primary outcomes:
measure: Proportion of adult patients undergoing ARI-relevant microbiology and virology investigations.
timeFrame: Four years
measure: Proportion of adult patients receiving antibiotics, antivirals, antifungals and/or immunomodulators.
timeFrame: Four years
measure: Clinical outcome of adults with community acquired ARI in acute hospital settings in Europe.
timeFrame: Last day in hospital, at death or 28 days after admission, whichever comes first.
measure: Length of hospital and/or ICU stay in adults with community acquired ARI in acute hospital settings in Europe.
timeFrame: Last day in hospital, at death or 28 days after admission, whichever comes first.
measure: Duration of NIV and IMV/ECMO in adults with community acquired ARI in acute hospital settings in Europe.
timeFrame: Last day in hospital, at death or 28 days after admission, whichever comes first.
measure: All cause mortality in adults with community acquired ARI in acute hospital settings in Europe.
timeFrame: Last day in hospital, at death or 28 days after admission, whichever comes first.
Secondary outcomes:
measure: Patient demographics of the adult patient population with ARI presenting to acute hospital settings in Europe.
timeFrame: Four years
measure: Comorbidities in the adult patient population with ARI presenting to acute hospital settings in Europe.
timeFrame: Four years
measure: Presenting symptoms in the adult patient population with ARI presenting to acute hospital settings in Europe.
timeFrame: Four years
measure: Physiological measurements in the adult patient population with ARI presenting to acute hospital settings in Europe.
timeFrame: Four years
measure: Aetiology of ARI in adults presenting to acute hospital settings in Europe.
timeFrame: Four years
Other outcomes:
measure: Association between clinical outcomes and diagnostic or treatment related variables, for different aetiologies of community acquired ARI in adults presenting to hospital across Europe.
timeFrame: Last day in hospital, at death or 28 days after admission, whichever comes first.
Locations:
city: Brussels
country: Belgium
facility: Erasme Hospital
city: Zagreb
country: Croatia
facility: University Hospital for Infectious Diseases, Zagreb
city: Grenoble
country: France
facility: CHU Grenoble
city: Limoges
country: France
facility: CHU Limoges
city: Lyon
country: France
facility: CHU Lyon
city: Tours
country: France
facility: CHU de Tours
city: Patras
country: Greece
facility: General University Hospital of Patras
city: Bari
country: Italy
facility: Azienda Ospedaliera Policlinico di Bari
city: Alkmaar
country: Netherlands
facility: Noordwest Ziekenhuisgroep
city: Nijmegen
country: Netherlands
facility: Radboud University Medical Center
city: Bucharest
country: Romania
facility: Agrippa Ionescu Hospital, Carol Davila University of Medicine and Pharmacy Bucharest
city: Bucharest
country: Romania
facility: Infectious and Tropical Diseases Hospital "Dr. Victor Babes"
city: Cluj Napoca
country: Romania
facility: Cluj Napoca Infectious Disease Clinical Hospital
city: Kragujevac
country: Serbia
facility: General Hospital, Kragujevac
city: Alicante
country: Spain
facility: Hospital General Universitario de Alicante
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Macarena
city: Craigavon
country: United Kingdom
facility: Craigavon Area Hospital
city: Edinburgh
country: United Kingdom
facility: NHS Lothian- Royal Infirmary of Edinburgh and St Johns Hospital
city: Gateshead
country: United Kingdom
facility: Gateshead Health NHS Foundation Trust
city: Liverpool
country: United Kingdom
facility: Liverpool University Hospitals NHS Foundation Trust
city: London
country: United Kingdom
facility: Royal Free London NHS Foundation Trust - Royal Free Hospital
city: Sheffield
country: United Kingdom
facility: Sheffield Teaching Hospitals NSH Foundation Trust
city: Sunderland
country: United Kingdom
facility: South Tyneside and Sunderland NHS Foundation
Study officials:
References: