How major respiratory viruses affect independence in older adults
Assessment of Functional Impact of Acute Respiratory Viral Infections in Older Adults - An International Multi-center Study
This study will see if hospitalization for common respiratory viruses (like flu, COVID-19, RSV, or hMPV) leads to loss of independence in people aged 60 and older.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1600 (estimated) |
| Ages | 60 Years and up |
| Sex | All |
| Sponsor | University Hospital, Grenoble Academic / other |
| Locations | 24 sites (Rochester, New York and 23 other locations) |
| Trial ID | NCT07388173 on ClinicalTrials.gov |
What this trial studies
This is an international observational study enrolling people aged 60 and older who are hospitalized with PCR-confirmed influenza, SARS-CoV-2, respiratory syncytial virus, or human metapneumovirus. Participants' baseline function and clinical course during hospitalization will be recorded, and functional outcomes will be followed by phone at about 3 and 6 months after discharge. The study will compare loss of autonomy, changes in activities of daily living, and recovery trajectories across different viral causes and patient subgroups. Findings are meant to inform targeted prevention and vaccination strategies for older adults.
Who should consider this trial
Good fit: Ideal participants are people aged 60 or older who are hospitalized at a participating center with a PCR-confirmed infection by influenza, SARS-CoV-2, RSV, or hMPV and who can complete follow-up calls.
Not a fit: People with severe baseline disability, terminal illness, advanced dementia, inability to complete follow-up assessments, or infections caused by pathogens other than the listed viruses are unlikely to benefit from this study's findings for their care.
Why it matters
Potential benefit: If successful, the study could help target prevention and vaccination efforts to reduce hospitalizations and long-term loss of independence in older adults.
How similar studies have performed: Prior efforts such as the IMI VITAL project and the AEQUI case-control study have provided insights into infections in older adults, but data specifically quantifying post-infectious functional decline and recovery remain limited.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Rochester, New York and 23 other locations
- University of Rochester School of Medicine, Infectious Diseases Unit — Rochester, New York, United States (Recruiting)
- University Hospital of Amiens — Amiens, France (Active_not_recruiting)
- Melun Hospital — Melun, France (Recruiting)
- Villeneuve Saint Georges Hospital — Paris, France (Active_not_recruiting)
- University Hospital of Poitiers — Poitiers, France (Active_not_recruiting)
- University Hospital of Reims — Reims, France (Active_not_recruiting)
- University Hospital of Tours — Tours, France (Active_not_recruiting)
- Klinikum Bayreuth, Klinik für Geriatrie — Bayreuth, Germany (Not_yet_recruiting)
- Abteilung Geriatrie Universitätsmedizin Göttingen, Abteilung Geriatrie — Göttingen, Germany (Not_yet_recruiting)
- Uniklinikum Jena, Klinik für Geriatrie — Jena, Germany (Not_yet_recruiting)
- Universitätsmedizin Mannheim, IV. Medizinische Klinik (Geriatrie) — Mannheim, Germany (Not_yet_recruiting)
- Klinikum Ulm, Geriatrisches Zentrum Agaplesion Bethesda — Ulm, Germany (Not_yet_recruiting)
- University of Bari, Bari — Bari, Italy (Not_yet_recruiting)
- Azienda Ospedaliero Universitaria "Renato Dulbecco", Catanzaro — Catanzaro, Italy (Not_yet_recruiting)
- ULSS 5 Polesana, Rovigo — Rovigo, Italy (Not_yet_recruiting)
- ASL 1 Imperiese, Sanremo — Sanremo, Italy (Not_yet_recruiting)
- Città di Torino, Torino — Torino, Italy (Not_yet_recruiting)
- APSS Trento, Geriatria, Trento — Trento, Italy (Not_yet_recruiting)
- ASUGI, Trieste — Trieste, Italy (Not_yet_recruiting)
- ULSS 3 Serenissima, Venice — Venice, Italy (Not_yet_recruiting)
- ULSS 9 Scaligera, Legnago, Verona — Verona, Italy (Not_yet_recruiting)
- Hospital Clínic Barcelona Servicio de Geriatría — Barcelona, Spain (Recruiting)
- Hospital Universitario Ramón y Cajal. Madrid Servicio de Geriatría — Madrid, Spain (Not_yet_recruiting)
- Hospital Universitario Virgen de la Arrixaca Murcia Servicio de Geriatría — Murcia, Spain (Not_yet_recruiting)
Study contacts
- Study coordinator: Gaetan GAVAZZI, MD,PhD
- Email: GGavazzi@chu-grenoble.fr
- Phone: 0033(0)476766760
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.