Infectious Diseases in Aged Population
NCT04825132
Bacteremia, Bacterial Infections
Amiens, France
View Trial DetailsNCT Number: NCT07388173
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.
Interested in participating?
Request Info60 year and older
All sexes
Observational
University Hospital of Amiens, Amiens, France
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.
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: Baseline, at hospital discharge, 3 months after discharge, and 6 months after discharge.
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, Day 7, 3 months after discharge, and 6 months after discharge.
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.
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.
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: From hospital admission to 6 months after discharge.
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.
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: 3 months after discharge
Duration of the index hospitalization, measured in days, calculated from hospital admission (Day 1) to hospital discharge.
Time frame: 3 months after hospital discharge.
Proportion of participants admitted to an intensive care unit during the index hospitalization.
Time frame: From at hospital discharge to 6 months after discharge.
Occurrence of hospital readmissions between discharge and 6 months after discharge.
Time frame: From hospital admission to 6 months after discharge.
Initiation of new drug treatments during hospitalization or within 6 months after discharge.
Time frame: 3 months after hospital discharge.
Location at hospital discharge (e.g., home, rehabilitation facility, long-term care facility).
Time frame: 6 months after hospital discharge.
Living situation of participants at 6 months after hospital discharge
Time frame: Baseline.
Baseline demographic characteristics of participants, including age and sex.
Time frame: Baseline.
Living situation of participants prior to hospital admission.
Time frame: Baseline.
Prevalence of pre-existing comorbidities at baseline.
Time frame: Baseline.
Proportion of participants vaccinated against influenza, SARS-CoV-2, and respiratory syncytial virus (RSV).
Time frame: Baseline.
Time elapsed since the most recent vaccination against influenza, SARS-CoV-2, or RSV, measured in months.
Time frame: Baseline
Severity of pneumonia assessed using the Pneumonia Severity Index (PSI) score at hospital admission.
Contact information is provided by the study sponsor or research team.
Gaetan GAVAZZI, MD,PhD
CONTACT
Saber TOUATI, PhD
CONTACT
University Hospital, Grenoble
Other
Assessment of Functional Impact of Acute Respiratory Viral Infections in Older Adults - An International Multi-center Study
Acronym: AFIRI
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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