Functional Impact of Acute Respiratory Viral Infections in Older Adults
ConditionRespiratory Infections in Old Age
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age60+
SponsorUniversity Hospital, Grenoble
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial 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.
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
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.
Time frame
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.
Time frame
Baseline, Day 7, 3 months after discharge, and 6 months after discharge.Secondary outcomes
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)).
Time frame
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)).
Time frame
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.
Time frame
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.
Time frame
From hospital admission to 6 months after discharge.Sponsors and contacts
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Source ClinicalTrials.gov