Functional Impact of Acute Respiratory Viral Infections in Older Adults

Official title

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

Overview

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.

Primary outcome measures

• 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.]
• 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.]

Secondary outcome measures (12)

• 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.]
• 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.]
• Medical Complications during and after hospitalization [Time frame: From hospital admission to 6 months after discharge.]
• Health Care Resource Utilization (HCRU) [Time frame: From hospital admission to 6 months after discharge.]
• Length of Hospital Stay [Time frame: 3 months after discharge]
• Intensive Care Unit (ICU) Admission [Time frame: 3 months after hospital discharge.]
• Hospital Readmissions After Discharge [Time frame: From at hospital discharge to 6 months after discharge.]
• New Medications Initiated [Time frame: From hospital admission to 6 months after discharge.]
• Discharge Location after Hospitalization [Time frame: 3 months after hospital discharge.]
• Living Situation at 6 Months after Discharge [Time frame: 6 months after hospital discharge.]
• Demographic Characteristics of Participants [Time frame: Baseline.]
• Living Situation at Baseline [Time frame: Baseline.]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model

Case-only

Study locations

Italy · 9 centers

• University of Bari, Bari — Bari
• Azienda Ospedaliero Universitaria "Renato Dulbecco", Catanzaro — Catanzaro
• ULSS 5 Polesana, Rovigo — Rovigo
• ASL 1 Imperiese, Sanremo — Sanremo
• Città di Torino, Torino — Torino
• APSS Trento, Geriatria, Trento — Trento
• ASUGI, Trieste — Trieste
• ULSS 3 Serenissima, Venice — Venice
• … and 1 more center

France · 6 centers

• University Hospital of Amiens — Amiens
• Melun Hospital — Melun
• Villeneuve Saint Georges Hospital — Paris
• University Hospital of Poitiers — Poitiers
• University Hospital of Reims — Reims
• University Hospital of Tours — Tours

Germany · 5 centers

• Klinikum Bayreuth, Klinik für Geriatrie — Bayreuth
• Abteilung Geriatrie Universitätsmedizin Göttingen, Abteilung Geriatrie — Göttingen
• Uniklinikum Jena, Klinik für Geriatrie — Jena
• Universitätsmedizin Mannheim, IV. Medizinische Klinik (Geriatrie) — Mannheim
• Klinikum Ulm, Geriatrisches Zentrum Agaplesion Bethesda — Ulm

Spain · 3 centers

• Hospital Clínic Barcelona Servicio de Geriatría — Barcelona
• Hospital Universitario Ramón y Cajal. Madrid Servicio de Geriatría — Madrid
• Hospital Universitario Virgen de la Arrixaca Murcia Servicio de Geriatría — Murcia

United States · 1 center

• University of Rochester School of Medicine, Infectious Diseases Unit — Rochester

Identifiers

NCT: NCT07388173 · 38RC25.0367

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗