POS-ARI-ER Observational Study of Acute Respiratory Infections

NCT05814237 | Recruiting DMC

• 1 other identifier: ECRAID-Base POS-ARI-ER
• Study Type: observational
• Target: 11,750
• Locations: 10 countries
• Sites: 23

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.

Conditions

Acute Respiratory Infection; Acute Respiratory Tract Infection

Keywords

Infections; Communicable Diseases

Outcome Measures

Primary Outcomes (6)

• Proportion of adult patients undergoing ARI-relevant microbiology and virology investigations.

  Calculate the proportion of types of ARI-relevant microbiology and virology investigations performed.

  Four years

• Proportion of adult patients receiving antibiotics, antivirals, antifungals and/or immunomodulators.

  Calculate the proportion of cases receiving antibiotics, antivirals, antifungals and/or immunomodulators.

  Four years

• Clinical outcome of adults with community acquired ARI in acute hospital settings in Europe.

  Maximal score using the ordinal scale assessed at discharge, death or at 28 days after hospital admission: 6= death, 5= hospitalisation requiring extracorporeal membrane oxygenation (ECMO) and/or invasive mechanical ventilation, 4= hospitalisation requiring non invasive ventilation (NIV) and/or high flow nasal cannula (HFNC) oxygen therapy, 3= requiring supplemental oxygen (but not NIV/HFNC), 2= hospitalisation not requiring supplemental oxygen, 1= not hospitalised.

  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.

  Number of days patient admitted to hospital or ICU.

  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.

  Number of days patients receiving NIV and IMV/ECMO.

  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.

  Total number of deaths for each ARI-related pathogen.

  Last day in hospital, at death or 28 days after admission, whichever comes first.

Secondary Outcomes (5)

• Patient demographics of the adult patient population with ARI presenting to acute hospital settings in Europe.

  Four years

• Comorbidities in the adult patient population with ARI presenting to acute hospital settings in Europe.

  Four years

• Presenting symptoms in the adult patient population with ARI presenting to acute hospital settings in Europe.

  Four years

• Physiological measurements in the adult patient population with ARI presenting to acute hospital settings in Europe.

  Four years

• Aetiology of ARI in adults presenting to acute hospital settings in Europe.

  Four years

Other Outcomes (1)

• Association between clinical outcomes and diagnostic or treatment related variables, for different aetiologies of community acquired ARI in adults presenting to hospital across Europe.

  Last day in hospital, at death or 28 days after admission, whichever comes first.

Interventions

Data collection OTHER

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients with community acquired acute respiratory infections presenting to acute hospital settings in Europe.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• European Clinical Research Alliance for Infectious Diseases (ECRAID): lead
• UMC Utrecht: collaborator
• University of Oxford: collaborator

Study Sites (23)

Erasme Hospital

Brussels, Belgium

RECRUITING

University Hospital for Infectious Diseases, Zagreb

Zagreb, Croatia

RECRUITING

CHU Grenoble

Grenoble, France

RECRUITING

CHU Limoges

Limoges, France

RECRUITING

CHU Lyon

Lyon, France

RECRUITING

CHU de Tours

Tours, France

RECRUITING

General University Hospital of Patras

Pátrai, Greece

RECRUITING

Azienda Ospedaliera Policlinico di Bari

Bari, Italy

RECRUITING

Noordwest Ziekenhuisgroep

Alkmaar, Netherlands

RECRUITING

Radboud University Medical Center

Nijmegen, Netherlands

RECRUITING

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

Bucharest, Romania

RECRUITING

Infectious and Tropical Diseases Hospital "Dr. Victor Babes"

Bucharest, Romania

RECRUITING

Cluj Napoca Infectious Disease Clinical Hospital

Cluj-Napoca, Romania

RECRUITING

General Hospital, Kragujevac

Kragujevac, Serbia

RECRUITING

Hospital General Universitario de Alicante

Alicante, Spain

RECRUITING

Hospital Universitario Virgen Macarena

Seville, Spain

RECRUITING

Craigavon Area Hospital

Craigavon, United Kingdom

RECRUITING

NHS Lothian- Royal Infirmary of Edinburgh and St Johns Hospital

Edinburgh, United Kingdom

RECRUITING

Gateshead Health NHS Foundation Trust

Gateshead, United Kingdom

RECRUITING

Liverpool University Hospitals NHS Foundation Trust

Liverpool, United Kingdom

RECRUITING

Royal Free London NHS Foundation Trust - Royal Free Hospital

London, United Kingdom

RECRUITING

Sheffield Teaching Hospitals NSH Foundation Trust

Sheffield, United Kingdom

RECRUITING

South Tyneside and Sunderland NHS Foundation

Sunderland, United Kingdom

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Nasal and throat swab

MeSH Terms

Conditions

Infections; Communicable Diseases

Interventions

Data Collection

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Central Study Contacts

Yrene Themistocleous

CONTACT

01865 612979; pos-ari-er@ndm.ox.ac.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2023
• First Posted: April 14, 2023
• Study Start: June 20, 2023
• Primary Completion: February 28, 2026
• Study Completion: February 28, 2026
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1); NL (2); ES (2); RO (3); CR (1); IT (1); FR (4); BE (1); GR (1); GB (7)