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Respiratory Infections in Old AgeAFIRINCT07388173

Functional Impact of Acute Respiratory Viral Infections in Older Adults

An observational study of Respiratory Infections in Old Age, run by University Hospital, Grenoble at 24 sites in 5 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The prevention of infectious diseases in older adults remains a major public health challenge, as acute respiratory infections are a leading cause of hospitalisation, mortality, and functional decline worldwide. Read more about this study

Who is it for?
Ages 60 years and older
Conditions the study is for
Respiratory Infections in Old Age
How many people
1,600 participants
Where
24 sitesin 5 countries
Study dates
15 Jan 2026to 15 Jun 2028
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 60 years and older
  • All sexes
  • Adult, Older adult

Study population: The study population will include participants aged 60 years or older who are hospitalized with a serious acute respiratory infection in the departments of infectious diseases, geriatrics, internal medicine, pulmonology, or emergency medicine. Recruitment will be conducted by investigator physicians in each participating department. Potentially eligible participants will be identified by daily screening of admission records and results from standard of care respiratory samples. Each country will aim to recruit approximately 320 participants - 80 with each pathogen of interest. Efforts will be made to secure an equal distribution of participants aged 60-75 and >75 years age.

Who may be able to join

  • Male or female subjects aged 60 years or older
  • Hospitalized in a study center (emergency department, infectious disease, internal medicine or geriatric hospital wards…) for acute respiratory infection (refer to table 1 below for definition).
  • Confirmed positive PCR test for influenza, SARS-CoV-2, RSV, or human metapneumovirus (hMPV). Participants with co-infections with other viral or bacterial agents can be included.

Who cannot join

  • Participants with conditions significantly impacting short-term functional status, such as severe disability (ADL score ≤2 or Clinical Frailty Scale ≥7), terminal illness, palliative care needs, or inability to comprehend and complete study questionnaires due to severe stroke sequelae, complete sensory loss, advanced dementia, or similar impairments.
  • Participants that refuse or are unable to answer the 3- and 6-months follow-up phone call assessments
  • Positive laboratory test for single (mono-infection) virus other than influenza, SARS-CoV-2, RSV, or human metapneumovirus (HMPV)
  • Participant in exclusion period for another study using an investigational / unapproved medicinal product.
  • Participant referred to in articles L1121-5 to L1121-8 of the CSP (corresponding to all protected persons : pregnant woman, parturient, breastfeeding mother, person deprived of liberty by judicial or administrative decision, persons undergoing psychiatric care under articles L.3212-1 and L.3213-1 who do not fall under article L.1121-8, persons admitted to a healthcare or social institution for purposes other than research, minors, person under legal protection or unable to express consent).
  • Individuals opposed to participating in the research
  • Staff members with a hierarchical relationship to the principal investigator

Trial locations and contacts

24 sites in 5 countries. Contact the study team or a site near you to ask about taking part.

Gaetan GAVAZZI, MD,PhD contact

0033(0)476766760

GGavazzi@chu-grenoble.fr

Saber TOUATI, PhD contact

0033(0)476765805

stouati1@chu-grenoble.fr

24 sites in 5 countries

Italy9 sites, 9 recruiting

  • University of Bari, Bari

    Bari

    Francesco Di Gennaro, MD

    Not yet recruiting

  • Azienda Ospedaliero Universitaria "Renato Dulbecco", Catanzaro

    Catanzaro

    Elvira Bonacci, MD

    Not yet recruiting

  • ULSS 5 Polesana, Rovigo

    Rovigo

    Pierluigi Dal Santo, MD

    Not yet recruiting

  • ASL 1 Imperiese, Sanremo

    Sanremo

    Giovanni Cenderello, MD

    Not yet recruiting

  • Città di Torino, Torino

    Torino

    Antonino Maria Cotroneo, MD

    Not yet recruiting

  • APSS Trento, Geriatria, Trento

    Trento

    Anna Casanova, MD

    Not yet recruiting

  • ASUGI, Trieste

    Trieste

    Michela Zanetti, MD

    Not yet recruiting

  • ULSS 3 Serenissima, Venice

    Venice

    Ernesto Rampin, MD

    Not yet recruiting

  • ULSS 9 Scaligera, Legnago, Verona

    Verona

    Margherita Azzini, MD

    Not yet recruiting

Other trials in Italy

France6 sites, 1 recruiting

  • University Hospital of Amiens

    Amiens

    Active, not recruiting

  • Melun Hospital

    Melun

    Sylvain DIAMANTIS, MD

    Recruiting

  • Villeneuve Saint Georges Hospital

    Paris

    Active, not recruiting

  • University Hospital of Poitiers

    Poitiers

    Active, not recruiting

  • University Hospital of Reims

    Reims

    Active, not recruiting

  • University Hospital of Tours

    Tours

    Active, not recruiting

Other trials in France

Germany5 sites, 5 recruiting

  • Klinikum Bayreuth, Klinik für Geriatrie

    Bayreuth

    Hans-Jürgen Heppner, MD PhD

    Not yet recruiting

  • Abteilung Geriatrie Universitätsmedizin Göttingen, Abteilung Geriatrie

    Göttingen

    Christine Von Arnim, MD PhD

    Not yet recruiting

  • Uniklinikum Jena, Klinik für Geriatrie

    Jena

    Kristin Häseler-Ouart, MD

    Not yet recruiting

  • Universitätsmedizin Mannheim, IV. Medizinische Klinik (Geriatrie)

    Mannheim

    Heinrich Burkhardt, MD PhD

    Not yet recruiting

  • Klinikum Ulm, Geriatrisches Zentrum Agaplesion Bethesda

    Ulm

    Michael Denkinger, MD PhD

    Not yet recruiting

Other trials in Germany

Spain3 sites, 3 recruiting

  • Hospital Clínic Barcelona Servicio de Geriatría

    Barcelona

    Juan Manuel Pérez Castejón, MD

    Recruiting

  • Hospital Universitario Ramón y Cajal. Madrid Servicio de Geriatría

    Madrid

    Alfonso J. Cruz Jentoft, MD

    Not yet recruiting

  • Hospital Universitario Virgen de la Arrixaca Murcia Servicio de Geriatría

    Murcia

    Juan Dionisio Avilés Hernández, MD

    Not yet recruiting

Other trials in Spain

United States1 site, 1 recruiting

  • University of Rochester School of Medicine, Infectious Diseases Unit

    Rochester, New York, 14642

    Edward Walsh, MD PhD

    Recruiting

Other trials in United States

About this study

Official title: Assessment of Functional Impact of Acute Respiratory Viral Infections in Older Adults - An International Multi-center Study

The prevention of infectious diseases in older adults remains a major public health challenge, as acute respiratory infections are a leading cause of hospitalisation, mortality, and functional decline worldwide. Immunosenescence and environmental exposures increase susceptibility to infection and reduce vaccine effectiveness in this population. Respiratory viruses, including influenza, SARS-CoV-2, respiratory syncytial virus, and human metapneumovirus, account for a substantial share of this burden, much of which is vaccine-preventable. However, their impact on functional decline and recovery in older adults remains insufficiently characterized. This international study aims to assess the effect of hospitalization for major respiratory viral infections on loss of autonomy in individuals aged 60 years and older, to inform targeted prevention and vaccination strategies.

Read the detailed description

The prevention of infectious diseases in older adults represents a major public health challenge due to their substantial impact on morbidity, mortality, and loss of functional capacity. Acute respiratory infections are among the leading causes of hospitalization and death in this population worldwide.

Ageing is associated with a progressive decline in immune function, resulting in increased susceptibility to infections and reduced vaccine effectiveness. In addition, environmental factors such as residence in collective living settings and repeated exposure to healthcare environments further increase the risk of exposure to and transmission of infectious agents.

The pathogens most frequently involved include respiratory viruses namely influenza, SARS-CoV-2, respiratory syncytial virus, and human metapneumovirus as well as bacterial pathogens, particularly Streptococcus pneumoniae, and certain fungal agents. A substantial proportion of these infections are potentially preventable through vaccination.

Despite advances generated by the European IMI VITAL project and the AEQUI case-control study, data remain limited regarding the functional consequences of acute respiratory infections in older adults, particularly their impact on dependency, frailty, and post-infectious recovery.

This international study aims to address these knowledge gaps by evaluating the impact of hospitalizations related to influenza, SARS-CoV-2, respiratory syncytial virus, and human metapneumovirus on loss of autonomy in individuals aged 60 years and older. The findings are expected to strengthen the scientific evidence base needed to inform targeted vaccination and prevention strategies, ultimately contributing to healthier ageing.

Keywords
functional dependency, respiratory infection, elderly people
Medical subject headings
Respiratory Tract Infections

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Evolution of Functional Dependency assessed by Activities of Daily Living (ADL) Score

    Change in functional performance measured using the Activities of Daily Living (ADL) scale. The ADL score ranges from 0 to 6, where higher scores indicate better functional independence The ADL score ranges from 0 to 6, where higher scores indicate better functional independence.

    Measured: Baseline, at hospital discharge, 3 months after discharge, and 6 months after discharge.

  2. Evolution of Functional Dependency assessed by Instrumental Activities of Daily Living (IADL) Score

    Change in functional performance measured using the Instrumental Activities of Daily Living (IADL) scale. The IADL score ranges from 0 to 8, where higher scores indicate better functional independence.

    Measured: Baseline, Day 7, 3 months after discharge, and 6 months after discharge.

Secondary outcomes (16)

  1. Functional Status depending on Viral Etiology Assessed by Activities of Daily Living (ADL) Score

    Change in functional status measured using the Activities of Daily Living (ADL) scale.

    The ADL score ranges from 0 to 6, where higher scores indicate better functional independence. Changes in score will be assessed between baseline, hospital discharge, 3 months, and 6 months, and stratified by viral etiology (SARS-CoV-2, influenza, respiratory syncytial virus (RSV), and human metapneumovirus (hMPV)).

    Measured: Baseline, Day 7, 3 months after discharge, and 6 months after discharge.

  2. Functional Status depending on Viral Etiology Assessed by Instrumental Activities of Daily Living (IADL) Score

    Change in functional status measured using the Instrumental Activities of Daily Living (IADL) scale. The IADL score ranges from 0 to 8, where higher scores indicate better functional independence.

    Changes in score will be assessed between baseline, hospital discharge, 3 months, and 6 months, and stratified by viral etiology (SARS-CoV-2, influenza, respiratory syncytial virus (RSV), and human metapneumovirus (hMPV)).

    Measured: Baseline, Day 7, 3 months after discharge, and 6 months after discharge.

  3. Medical Complications during and after hospitalization

    Occurrence of medical complications during hospitalization and up to 6 months after discharge, including new diagnoses identified during follow-up.

    Measured: From hospital admission to 6 months after discharge.

  4. Health Care Resource Utilization (HCRU)

    Health care resource utilization, including hospital length of stay, intensive care unit (ICU) admission during index hospitalization, and hospital readmissions occurring between discharge and 6 months.

    Measured: From hospital admission to 6 months after discharge.

  5. Length of Hospital Stay

    Duration of the index hospitalization, measured in days, calculated from hospital admission (Day 1) to hospital discharge.

    Measured: 3 months after discharge

  6. Intensive Care Unit (ICU) Admission

    Proportion of participants admitted to an intensive care unit during the index hospitalization.

    Measured: 3 months after hospital discharge.

  7. Hospital Readmissions After Discharge

    Occurrence of hospital readmissions between discharge and 6 months after discharge.

    Measured: From at hospital discharge to 6 months after discharge.

  8. New Medications Initiated

    Initiation of new drug treatments during hospitalization or within 6 months after discharge.

    Measured: From hospital admission to 6 months after discharge.

  9. Discharge Location after Hospitalization

    Location at hospital discharge (e.g., home, rehabilitation facility, long-term care facility).

    Measured: 3 months after hospital discharge.

  10. Living Situation at 6 Months after Discharge

    Living situation of participants at 6 months after hospital discharge

    Measured: 6 months after hospital discharge.

  11. Demographic Characteristics of Participants

    Baseline demographic characteristics of participants, including age and sex.

    Measured: Baseline.

  12. Living Situation at Baseline

    Living situation of participants prior to hospital admission.

    Measured: Baseline.

  13. Prevalence of Comorbidities

    Prevalence of pre-existing comorbidities at baseline.

    Measured: Baseline.

  14. Vaccination Status

    Proportion of participants vaccinated against influenza, SARS-CoV-2, and respiratory syncytial virus (RSV).

    Measured: Baseline.

  15. Time since last vaccination

    Time elapsed since the most recent vaccination against influenza, SARS-CoV-2, or RSV, measured in months.

    Measured: Baseline.

  16. Pneumonia Severity Index (PSI) Score

    Severity of pneumonia assessed using the Pneumonia Severity Index (PSI) score at hospital admission.

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Feb 2026
  2. Study start15 Jan 2026
  3. Primary completion15 Jan 2028 (estimated)
  4. Study completion15 Jun 2028 (estimated)

Resources

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
Case only
Time perspective
Prospective
Enrolment
1,600 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07388173
Sponsor's protocol ID
38RC25.0367
Acronym
AFIRI
Status last verified
May 2026
First submitted
29 Dec 2025
Last updated
8 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Respiratory Infections in Old Age, run by University Hospital, Grenoble at 24 sites in 5 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 3 inclusion and 7 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 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 24 sites in Italy, France, Germany, Spain, United States. 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 Gaetan GAVAZZI, MD,PhD (0033(0)476766760, GGavazzi@chu-grenoble.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evolution of Functional Dependency assessed by Activities of Daily Living (ADL) Score (time frame: Baseline, at hospital discharge, 3 months after discharge, and 6 months after discharge.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07388173.

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 8 May 2026.

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