Functional Impact of Acute Respiratory Viral Infections in Older Adults

NCT07388173 | Not Yet Recruiting

• 1 other identifier: 38RC25.0367
• Study Type: observational
• Target: 1,600
• Locations: 5 countries
• Sites: 24

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.

Conditions

Respiratory Infections in Old Age

Keywords

functional dependency; respiratory infection; elderly people

Outcome Measures

Primary Outcomes (2)

• 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.

  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

  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.

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

Secondary Outcomes (16)

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

  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

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

• Medical Complications during and after hospitalization

  From hospital admission to 6 months after discharge.

• Health Care Resource Utilization (HCRU)

  From hospital admission to 6 months after discharge.

• Length of Hospital Stay

  3 months after discharge

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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 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

Sponsors & Collaborators

• University Hospital, Grenoble: lead

Study Sites (24)

University of Rochester School of Medicine, Infectious Diseases Unit

Rochester, New York, 14642, United States

Location

University Hospital of Amiens

Amiens, France

Location

Melun Hospital

Melun, France

Location

Villeneuve Saint Georges Hospital

Paris, France

Location

University Hospital of Poitiers

Poitiers, France

Location

University Hospital of Reims

Reims, France

Location

University Hospital of Tours

Tours, France

Location

Klinikum Bayreuth, Klinik für Geriatrie

Bayreuth, Germany

Location

Abteilung Geriatrie Universitätsmedizin Göttingen, Abteilung Geriatrie

Göttingen, Germany

Location

Uniklinikum Jena, Klinik für Geriatrie

Jena, Germany

Location

Universitätsmedizin Mannheim, IV. Medizinische Klinik (Geriatrie)

Mannheim, Germany

Location

Klinikum Ulm, Geriatrisches Zentrum Agaplesion Bethesda

Ulm, Germany

Location

University of Bari, Bari

Bari, Italy

Location

Azienda Ospedaliero Universitaria "Renato Dulbecco", Catanzaro

Catanzaro, Italy

Location

ULSS 5 Polesana, Rovigo

Rovigo, Italy

Location

ASL 1 Imperiese, Sanremo

Sanremo, Italy

Location

Città di Torino, Torino

Torino, Italy

Location

APSS Trento, Geriatria, Trento

Trento, Italy

Location

ASUGI, Trieste

Trieste, Italy

Location

ULSS 3 Serenissima, Venice

Venice, Italy

Location

ULSS 9 Scaligera, Legnago, Verona

Verona, Italy

Location

Hospital Clínic Barcelona Servicio de Geriatría

Barcelona, Spain

Location

Hospital Universitario Ramón y Cajal. Madrid Servicio de Geriatría

Madrid, Spain

Location

Hospital Universitario Virgen de la Arrixaca Murcia Servicio de Geriatría

Murcia, Spain

Location

MeSH Terms

Conditions

Respiratory Tract Infections

Condition Hierarchy (Ancestors)

Infections; Respiratory Tract Diseases

Central Study Contacts

Gaetan GAVAZZI, MD,PhD

CONTACT

0033(0)476766760; GGavazzi@chu-grenoble.fr

Saber TOUATI, PhD

CONTACT

0033(0)476765805; stouati1@chu-grenoble.fr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 29, 2025
• First Posted: February 4, 2026
• Study Start: January 15, 2026
• Primary Completion (Estimated): January 15, 2027
• Study Completion (Estimated): June 15, 2027
• Last Updated: February 4, 2026

Record last verified: 2026-01

Locations

DE (5); IT (9); US (1); FR (6); ES (3)