POS-ARI-ER Observational Study of Acute Respiratory Infections
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorEuropean Clinical Research Alliance for Infectious Diseases (ECRAID)
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
Adult patients with community acquired acute respiratory infections presenting to acute hospital settings in Europe.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Data collection
Other interventionData collection from study participants to characterise diagnostic and therapeutic practices.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Proportion of adult patients undergoing ARI-relevant microbiology and virology investigations.
Calculate the proportion of types of ARI-relevant microbiology and virology investigations performed.
Time frame
Four years2
Proportion of adult patients receiving antibiotics, antivirals, antifungals and/or immunomodulators.
Calculate the proportion of cases receiving antibiotics, antivirals, antifungals and/or immunomodulators.
Time frame
Four years3
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.
Time frame
Last day in hospital, at death or 28 days after admission, whichever comes first.4
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.
Time frame
Last day in hospital, at death or 28 days after admission, whichever comes first.Secondary outcomes
1
Patient demographics of the adult patient population with ARI presenting to acute hospital settings in Europe.
Evaluate demographics of patient population with ARI.
Time frame
Four years2
Comorbidities in the adult patient population with ARI presenting to acute hospital settings in Europe.
Evaluation of comorbidities in patient population with ARI.
Time frame
Four years3
Presenting symptoms in the adult patient population with ARI presenting to acute hospital settings in Europe.
Evaluation of presenting symptoms in the adult patient population with ARI.
Time frame
Four years4
Physiological measurements in the adult patient population with ARI presenting to acute hospital settings in Europe.
Evaluation of the physiological measurements in the adult patient population with ARI.
Time frame
Four yearsOther 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.
Maximal score on 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, stratified by pathogen.
Time frame
Last day in hospital, at death or 28 days after admission, whichever comes first.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
European Clinical Research Alliance for Infectious Diseases (ECRAID)
Lead sponsor
UMC Utrecht
Collaborator
University of Oxford
Collaborator
Source ClinicalTrials.gov