Recruiting

Observational Study

Sponsor:

University Hospital, Grenoble

Code:

NCT07388173

Conditions

Respiratory Infections in Old Age

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Not accepted

Study Details

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

Study ID

NCT07388173

Start date

Jan 15, 2026

Status verified date

May, 2026

Completion date

Jun 15, 2028

Anticipated

Primary completion date

Jan 15, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

1600 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • 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. ]

Central Contacts and Locations

Central contacts

Gaetan GAVAZZI, MD,PhD

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

Saber TOUATI, PhD

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

Locations

University of Rochester School of Medicine, Infectious Diseases Unit

Recruiting

Rochester, New York, United States, 14642

More Information

Sponsor

University Hospital, Grenoble

Last update posted

May 8, 2026

Last verified

May, 2026

Keywords

  • functional dependency
  • respiratory infection
  • elderly people

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University Hospital, Grenoble on 2026-05-08.