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Functional Impact of Acute Respiratory Viral Infections in Older Adults

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07388173
Acronym
AFIRI
Enrollment
1600
Registered
2026-02-04
Start date
2026-01-15
Completion date
2028-06-15
Last updated
2026-05-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Respiratory Infections in Old Age

Keywords

functional dependency, respiratory infection, elderly people

Brief 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. 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.

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.

Interventions

None listed

Sponsors

University Hospital, Grenoble
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
60 Years to No maximum

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

Design outcomes

Primary

MeasureTime frameDescription
Evolution of Functional Dependency assessed by Activities of Daily Living (ADL) ScoreBaseline, 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.
Evolution of Functional Dependency assessed by Instrumental Activities of Daily Living (IADL) ScoreBaseline, 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

MeasureTime frameDescription
Functional Status depending on Viral Etiology Assessed by Activities of Daily Living (ADL) ScoreBaseline, 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)).
Functional Status depending on Viral Etiology Assessed by Instrumental Activities of Daily Living (IADL) ScoreBaseline, 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)).
Medical Complications during and after hospitalizationFrom 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.
Health Care Resource Utilization (HCRU)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.
Length of Hospital Stay3 months after dischargeDuration of the index hospitalization, measured in days, calculated from hospital admission (Day 1) to hospital discharge.
Intensive Care Unit (ICU) Admission3 months after hospital discharge.Proportion of participants admitted to an intensive care unit during the index hospitalization.
Hospital Readmissions After DischargeFrom at hospital discharge to 6 months after discharge.Occurrence of hospital readmissions between discharge and 6 months after discharge.
New Medications InitiatedFrom hospital admission to 6 months after discharge.Initiation of new drug treatments during hospitalization or within 6 months after discharge.
Discharge Location after Hospitalization3 months after hospital discharge.Location at hospital discharge (e.g., home, rehabilitation facility, long-term care facility).
Living Situation at 6 Months after Discharge6 months after hospital discharge.Living situation of participants at 6 months after hospital discharge
Demographic Characteristics of ParticipantsBaseline.Baseline demographic characteristics of participants, including age and sex.
Living Situation at BaselineBaseline.Living situation of participants prior to hospital admission.
Prevalence of ComorbiditiesBaseline.Prevalence of pre-existing comorbidities at baseline.
Vaccination StatusBaseline.Proportion of participants vaccinated against influenza, SARS-CoV-2, and respiratory syncytial virus (RSV).
Time since last vaccinationBaseline.Time elapsed since the most recent vaccination against influenza, SARS-CoV-2, or RSV, measured in months.
Pneumonia Severity Index (PSI) ScoreBaselineSeverity of pneumonia assessed using the Pneumonia Severity Index (PSI) score at hospital admission.

Countries

France, Germany, Italy, Spain, United States

Contacts

CONTACTGaetan GAVAZZI, MD,PhD
GGavazzi@chu-grenoble.fr0033(0)476766760
CONTACTSaber TOUATI, PhD
stouati1@chu-grenoble.fr0033(0)476765805

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 9, 2026