Acute Respiratory InfectionPOS-ARI-ERNCT05814237
POS-ARI-ER Observational Study of Acute Respiratory Infections
An observational study of Acute Respiratory Infection and Acute Respiratory Tract Infection, run by European Clinical Research Alliance for Infectious Diseases (ECRAID) at 27 sites in 10 countries.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Acute Respiratory Infection, Acute Respiratory Tract Infection
- What is being tested?
- Data collection
- How many people
- 11,750 participants
- Where
- 27 sitesin 10 countries
- Study dates
- 20 Jun 2023to 28 Feb 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Group 1: Adults (≥ 18 years old) presenting to acute hospital services with suspected community-acquired acute respiratory tract infection Group 2: Infants, children and adolescents (< 18 years old) presenting to acute hospital services with suspected community-acquired acute respiratory tract infection
Who may be able to join
- Age ≥ 18 years
- 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
Who cannot join
- 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 locations and contacts
27 sites in 10 countries. Contact the study team or a site near you to ask about taking part.
27 sites in 10 countries
United Kingdom7 sites, 2 recruiting
- Recruiting
Craigavon Area Hospital
Craigavon
- Completed
NHS Lothian- Royal Infirmary of Edinburgh and St Johns Hospital
Edinburgh
- Completed
Gateshead Health NHS Foundation Trust
Gateshead
- Completed
Liverpool University Hospitals NHS Foundation Trust
Liverpool
- Completed
Royal Free London NHS Foundation Trust - Royal Free Hospital
London
- Completed
Sheffield Teaching Hospitals NSH Foundation Trust
Sheffield
- Recruiting
South Tyneside and Sunderland NHS Foundation
Sunderland
France4 sites, 1 recruiting
- Completed
CHU Grenoble
Grenoble
- Recruiting
CHU Limoges
Limoges
- Completed
CHU Lyon
Lyon
- Completed
CHU de Tours
Tours
Romania4 sites, 1 recruiting
- Completed
Agrippa Ionescu Hospital, Carol Davila University of Medicine and Pharmacy Bucharest
Bucharest
- Recruiting
Carol Davila University of Medicine and Pharmacy Bucharest
Bucharest
- Completed
Infectious and Tropical Diseases Hospital "Dr. Victor Babes"
Bucharest
- Completed
Cluj Napoca Infectious Disease Clinical Hospital
Cluj-Napoca
Netherlands3 sites, 2 recruiting
- Recruiting
Noordwest Ziekenhuisgroep
Alkmaar
- Recruiting
Amsterdam UMC
Amsterdam
- Completed
Radboud University Medical Center
Nijmegen
Spain3 sites, 3 recruiting
- Recruiting
Hospital General Universitario de Alicante
Alicante
- Recruiting
Hospital Universitario Vall d'Hebron
Barcelona
- Recruiting
Hospital Universitario Virgen Macarena
Seville
Belgium2 sites, 1 recruiting
- Recruiting
Universitair Ziekenhuis Antwerpen
Antwerp
- Completed
Erasme Hospital
Brussels
Croatia1 site
- Completed
University Hospital for Infectious Diseases, Zagreb
Zagreb
About this study
Official title: Perpetual Observational Study of Acute Respiratory Infections Presenting Via Emergency Rooms and Other Acute Hospital Care Settings
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 and paediatric patient populations with ARI presenting to acute hospital settings in Europe, and the aetiology of ARI in these patients.
Read the 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.
- Being tested
- Data collection
- Keywords
- Infections, Communicable Diseases
- Medical subject headings
- Infections, Communicable Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data collectionOther
Data collection from study participants to characterise diagnostic and therapeutic practices.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Adults ≥ 18 years old Receives: Other: Data collection | |
| Group 2 | Infants, children and adolescents < 18 years old Receives: Other: Data collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of adult patients undergoing ARI-relevant microbiology and virology investigations.
Calculate the proportion of types of ARI-relevant microbiology and virology investigations performed.
Measured: Five years
Proportion of adult patients receiving antibiotics, antivirals, antifungals and/or immunomodulators.
Calculate the proportion of cases receiving antibiotics, antivirals, antifungals and/or immunomodulators.
Measured: Five 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Evaluate demographics of patient population with ARI.
Measured: Five years
Comorbidities in the adult patient population with ARI presenting to acute hospital settings in Europe.
Evaluation of comorbidities in patient population with ARI.
Measured: Five years
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.
Measured: Five years
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.
Measured: Five years
Aetiology of ARI in adults presenting to acute hospital settings in Europe.
Detection of putative pathogens in respiratory tract samples (research upper respiratory tract sample at presentation and ARI-relevant microbiology/virology results obtained through routine clinical care).
Measured: Five years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2023
- Study start20 Jun 2023
- Primary completion28 Feb 2027 (estimated)
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Respiratory InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 11,750 participants (estimated)
Sponsor and investigators
- Lead sponsor
- European Clinical Research Alliance for Infectious Diseases (ECRAID)
- Sponsor type
- University, hospital or other
- Collaborators
- UMC Utrecht, University of Oxford
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05814237
- Sponsor's protocol ID
- ECRAID-Base POS-ARI-ER
- Acronym
- POS-ARI-ER
- Status last verified
- Apr 2026
- First submitted
- 27 Feb 2023
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perpetual Observational Study of Acute Respiratory Infections Presenting Via Emergency Rooms and Other Acute Hospital Care Settings
- ClinicalTrials.gov ID
- NCT05814237
- Acronym / sponsor ID
- POS-ARI-ER / ECRAID-Base POS-ARI-ER
- Keywords
- Infections, Communicable Diseases
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 11,750 participants (estimated)
- Lead sponsor
- European Clinical Research Alliance for Infectious Diseases (ECRAID)University, hospital or other
- Collaborators
- UMC Utrecht, University of Oxford
- Study start
- 20 Jun 2023 (actual)
- Primary completion
- 28 Feb 2027 (estimated)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 14 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 and paediatric patient populations 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Other: Data collectionAdults ≥ 18 years old |
| Group 2 | – | Other: Data collectionInfants, children and adolescents < 18 years old |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Group 1: Adults (≥ 18 years old) presenting to acute hospital services with suspected community-acquired acute respiratory tract infection Group 2: Infants, children and adolescents (< 18 years old) presenting to acute hospital services with suspected community-acquired acute respiratory tract infection
Key inclusion criteria (5 listed)
- Age ≥ 18 years
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Data collectionData collection from study participants to characterise diagnostic and therapeutic practices. | Other | Group 1, Group 2 |
Primary outcome
Proportion of adult patients undergoing ARI-relevant microbiology and virology investigations.
Time frame: Five years
Calculate the proportion of types of ARI-relevant microbiology and virology investigations performed.
Proportion of adult patients receiving antibiotics, antivirals, antifungals and/or immunomodulators.
Time frame: Five years
Calculate the proportion of cases receiving antibiotics, antivirals, antifungals and/or immunomodulators.
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.
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.
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.
Number of days patient admitted to hospital or ICU.
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.
Number of days patients receiving NIV and IMV/ECMO.
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.
Total number of deaths for each ARI-related pathogen.
5 secondary outcomes
Patient demographics of the adult patient population with ARI presenting to acute hospital settings in Europe.
Time frame: Five years
Comorbidities in the adult patient population with ARI presenting to acute hospital settings in Europe.
Time frame: Five years
Presenting symptoms in the adult patient population with ARI presenting to acute hospital settings in Europe.
Time frame: Five years
Physiological measurements in the adult patient population with ARI presenting to acute hospital settings in Europe.
Time frame: Five years
Aetiology of ARI in adults presenting to acute hospital settings in Europe.
Time frame: Five years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
27 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Respiratory Infection and Acute Respiratory Tract Infection, run by European Clinical Research Alliance for Infectious Diseases (ECRAID) at 27 sites in 10 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites in United Kingdom, France, Romania, Netherlands, Spain and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jake Dunning (01865 612974, pos-ari-er@ndm.ox.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of adult patients undergoing ARI-relevant microbiology and virology investigations. (time frame: Five years). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.