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NCT Number: NCT07388173

Functional Impact of Acute Respiratory Viral Infections in Older Adults

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.

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Key information

Age range

60 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital of Amiens, Amiens, France

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About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

Primary outcomes

  1. 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.

    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.

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

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

    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.

Secondary outcomes

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

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

    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)).

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

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

    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)).

  3. Medical Complications during and after hospitalization

    Time frame: From hospital admission to 6 months after discharge.

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

  4. Health Care Resource Utilization (HCRU)

    Time frame: From hospital admission to 6 months after discharge.

    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.

  5. Length of Hospital Stay

    Time frame: 3 months after discharge

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

  6. Intensive Care Unit (ICU) Admission

    Time frame: 3 months after hospital discharge.

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

  7. Hospital Readmissions After Discharge

    Time frame: From at hospital discharge to 6 months after discharge.

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

  8. New Medications Initiated

    Time frame: From hospital admission to 6 months after discharge.

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

  9. Discharge Location after Hospitalization

    Time frame: 3 months after hospital discharge.

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

  10. Living Situation at 6 Months after Discharge

    Time frame: 6 months after hospital discharge.

    Living situation of participants at 6 months after hospital discharge

  11. Demographic Characteristics of Participants

    Time frame: Baseline.

    Baseline demographic characteristics of participants, including age and sex.

  12. Living Situation at Baseline

    Time frame: Baseline.

    Living situation of participants prior to hospital admission.

  13. Prevalence of Comorbidities

    Time frame: Baseline.

    Prevalence of pre-existing comorbidities at baseline.

  14. Vaccination Status

    Time frame: Baseline.

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

  15. Time since last vaccination

    Time frame: Baseline.

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

  16. Pneumonia Severity Index (PSI) Score

    Time frame: Baseline

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

Study contacts

Contact information is provided by the study sponsor or research team.

Gaetan GAVAZZI, MD,PhD

CONTACT

[email protected]

0033(0)476766760

Saber TOUATI, PhD

CONTACT

[email protected]

0033(0)476765805

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Registry information

Official study title

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

Acronym: AFIRI

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Feb 4, 2026
Registry last updated
May 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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