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Respiratory Infections in Old AgeAEQUINCT04825132

Infectious Diseases in Aged Population

A study testing Geriatric assessment tools in people with Respiratory Infections in Old Age and Bacteremia, run by University Hospital, Grenoble at 22 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The increasing number of persons >65 years of age form a special population at risk for nosocomial and other health care-associated infections. The vulnerability of this age group is related to impaired host defenses such as diminished cell-mediated immunity. Read more about this study

Who is it for?
Ages 65 years and older
Conditions the study is for
Respiratory Infections in Old Age, Bacteremia
What is being tested?
Geriatric assessment tools
Could I receive a placebo?
No, everyone receives an active treatment
How many people
521 participants
Where
22 sitesin 3 countries
Study dates
1 Apr 2021to 30 Nov 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • Hospitalized adults 65 years or older,
  • Presenting with bacteremia with positive blood culture (excluding catheter related infections) and/or
  • WHO Severe Acute Respiratory Infection (SARI) case definition
  • Upper respiratory infection = SARI (fever or history of fever >38°C, cough, onset of the disease within the last 10 days and requires hospitalisation)
  • Lower respiratory infection = SARI with confirmed CT/CHR
  • Informed consent form signed
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  • Patient affiliated to social security insurance
  • Same age (+/- 3 years)
  • same sex,
  • without suspicion of infection
  • Hospitalized during the past or upcoming month in the same centre.
  • Informed consent form signed
  • Patient affiliated to social security insurance

Who cannot join

  • Bedridden or terminally ill patient (based upon a threshold of ADL: ≤2 TBD, or CLINICAL FRAILTY SCALE: ≥8 )
  • Patients that refuse the 3- and 6-months follow-up phone call assessments
  • Patients that will not be able to answer the 3- and 6-months follow-up phone call assessments via a nurse
  • Subject in exclusion period for another study,
  • Subject who cannot be contacted in an emergency
  • Persons referred to in Articles L1121-5 to L1121-8 of the French code of public health (this corresponds to all persons protected: pregnant or parturient women, breastfeeding mothers, persons deprived of liberty by judicial or administrative decision, persons subject to a legal protection measure).
Show all 12Show fewer
  • Bedridden or terminally ill patient (based upon a threshold of ADL: ≤2 TBD, or CLINICAL FRAILTY SCALE: ≥8 )
  • Patients that refuse the 3- and 6-months follow-up phone call assessments
  • Patients that will not be able to answer the 3- and 6-months follow-up phone call assessments via a nurse
  • Subject in exclusion period for another study,
  • Subject who cannot be contacted in an emergency
  • Persons referred to in Articles L1121-5 to L1121-8 of the French code of public health (this corresponds to all persons protected: pregnant or parturient women, breastfeeding mothers, persons deprived of liberty by judicial or administrative decision, persons subject to a legal protection measure)

Trial locations and contacts

22 sites in 3 countries.

22 sites in 3 countries

Italy11 sites
  • Policlinico Universitario Bari

    Bari

  • Unità Operativa Complessa di Geriatria-Camposampiero-ULSS 6

    Camposampiero

  • S.O.C. Geriatria-Catanzaro

    Catanzaro

  • Ospedale Civile di Dolo- ULSS 3 "Serenissima"

    Dolo

  • Ente Ospedaliero Galliera

    Genova

  • Unità Operativa Complessa di Geriatria-Legnago-ULSS 9

    Legnago

  • S.C. Geriatria Monza

    Monza

  • Azienda Ospedaliera Universitaria Policlinico di Palermo

    Palermo

  • Istituto di Geriatria e Gerontologia-Azienda Ospedaliera di Perugia

    Perugia

  • UOC Geriatria di Rovigo

    Rovigo

  • Malattie infettive - Sanremo

    Sanremo

Other trials in Italy

France7 sites
  • University Hospital Amiens

    Amiens

  • Hospital Chambery

    Chambéry

  • Groupe Hospitalier Sud Ile de France

    Melun

  • Groupement Hospitalier portes de Provence

    Montélimar

  • Centre Hospitalier Intercommunal de Villeneuve St Georges.

    Paris

  • University Hospital Poitiers

    Poitiers

  • CHRU Tours

    Tours

Other trials in France

Spain4 sites
  • FCRB - Fundació Clínic per a la Recerca Biomèdica

    Barcelona

  • FIBio-HCSC - Fundación para la Investigación Biomédica del Hospital Clínico San Carlos

    Madrid

  • FIBio-HRYC - Fundación para la Investigación Biomédica del Hospital Universitario Ramón y Cajal

    Madrid

  • Instituto Murciano de Investigación Biosanitaria Virgen de la Arrixaca

    Murcia

Other trials in Spain

About this study

Official title: Aged European Population QUality of Life in Infectious Diseases

The increasing number of persons >65 years of age form a special population at risk for nosocomial and other health care-associated infections. The vulnerability of this age group is related to impaired host defenses such as diminished cell-mediated immunity. Lifestyle considerations, e.g., travel and living arrangements, and residence in nursing homes, can further complicate the clinical picture. The magnitude and diversity of health care-associated infections in the aging population are generating new arenas for prevention and control efforts.

Common infections leading to hospitalizations in this age group result in respiratory infections and bacteraemia and the impact of these infections on the quality of life and disability in aged populations has not been accurately quantified in a European setting.

This study aims to capture and quantify the impact of infectious diseases on quality of life in an aged population.

Read the detailed description

An emerging public health challenge is to protect the growing ageing population from infectious diseases, which can significantly impact the quality of life of those affected.

The vulnerability of this age group is related to impaired host defenses such as diminished cell-mediated immunity. Lifestyle considerations, e.g., travel and living arrangements, and residence in nursing homes, can further complicate the clinical picture.

The increasing number of persons >65 years of age form a special population at risk for nosocomial and other health care-associated infections. The vulnerability of this age group is related to impaired host defenses such as diminished cell-mediated immunity. Lifestyle considerations, e.g., travel and living arrangements, and residence in nursing homes, can further complicate the clinical picture. The magnitude and diversity of health care-associated infections in the aging population are generating new arenas for prevention and control efforts.

Common infections leading to hospitalizations in this age group result in respiratory infections and bacteraemia and the impact of these infections on the quality of life in aged populations has not been accurately quantified in a European setting.

This study aims to capture and quantify the impact of infectious diseases on quality of life in an aged population.

The IMI European public-private partnership created the VITAL project (Vaccines and infectious diseases in the Ageing populations) to assess the infectious diseases burden and mechanisms of immunosenescence in the ageing populations. This aims to provide evidence-based knowledge on vaccination strategies to establish healthy ageing. The project articulates around five work packages and this study comes within the frame of the first one. The expected results of this work combine with and complete the retrospective assessment already done on the available datasets/databases.

The decreased efficiency of the cell-mediated immunity and more generally the immunosenescence make the ageing population prone to harming infectious diseases. That combined with the growth of the ageing populations make healthy ageing a major and current challenge to address. The common infections leading to hospitalizations in this age groups include respiratory infections and bacteremia.

Acute respiratory infections (ARI) are a leading cause of hospitalizations and death in the aged adult population. They can be caused by viruses (Influenza for instance), bacteria (Streptococcus pneumoniae for instance) and fungi, with either a single or a co-infection. Viruses and bacteria have a comparable share in causing ARI, and a significant part of them are vaccine preventable pathogens. Although the burden of ARI is highest in the ageing population, vaccine effectiveness is the lowest in this vulnerable population, mostly because of immunosenescence. This issue can be tackled by increasing vaccine coverage and efficiency and developing vaccines and treatments for the pathogens leaving physicians with limited prevention and therapeutic options.

Bacteremia is defined by the presence of viable bacteria in the circulating blood generally causing fever, chills, tachycardia, tachypnea, and sometimes requiring hospitalization. It increases morbidity and has a high mortality rate in all ageing populations. It is mostly caused by Gram negative (E. Coli, Proteus mirabilis, Klebsiella) but also by Gram positive bacteria (Staphylococcus aureus). Along with its high burden in this population, bacteremia is difficult to tackle because of an odd and nonspecific clinical presentation. In addition, bacteremia is associated with comorbidities, underlying diseases and long-term care centres stays. The increasing proportion of antimicrobial resistance such as methicillin-resistant Staphylococcus aureus (MRSA), vancomycin-resistant Staphylococcus aureus (VRSA) or extended spectrum beta-lactamase (ESBL) make complete eradication harder in a given patient and may alter his quality of life in a durable way.

There is a high ARI and bacteremia burden in the aged population in terms of morbidity and mortality. This burden is also believed to be expressed in terms of lower quality of life, and increased frailty and disability and has begun to be assessed in either of the two pathologies.

The impact of ARI and/or bacteremia on those components needs to be assessed in the most comprehensive way as the investigator are facing a specific population: a significant part of the ageing population is already relatively frail. Frailty has been demonstrated as a predictor of bad recovery after an ARI hospitalization in older adults, of being an adverse outcome of acute illness and of being associated with diminished vaccine effectiveness.

The impact of ARI and bacteremia hospitalization on quality of life, frailty and disability in that ageing population has not been assessed in a wide European setting to our knowledge. Filling this data gap will strengthen the evidence-based and guide public health policies concerning vaccination strategies to promote healthy ageing.

Being tested
Geriatric assessment tools
Keywords
functional dependency, quality of life, elderly people, respiratory infection, bacteraemia, disability
Medical subject headings
Bacteremia, Respiratory Tract Infections, Toxemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Geriatric assessment toolsOther

    Multidimensional Prognostic Index (Living status, medications, ADL, IADL, MMSE mental evaluation, ESS pressure sores, chronic disease, nutritional assessment)

Study groups in NCT04825132
Study groupRoleWhat they receive
Bacteremia and/or acute respiratory infectionExperimentalHospitalized in a study center (emergency department, infectious disease, internal medicine or geriatric hospital wards…) for with bacteraemia and/or acute respiratory infection
Receives: Other: Geriatric assessment tools
Without suspicion of infectionActive comparatorThe control patient will undergo the exact same procedures as the case patient described before except for the blood and respiratory sample part. • The typical control patient will be of the same age (+/- 3 years, but aged above 65 years), same sex, without suspicion of infection and hospitalized during the past or upcoming month in the same centre. There will be 2 controls for one case.
Receives: Other: Geriatric assessment tools

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Evolution of Functional dependency

    Change in activities of daily living (ADL) (Scores ADL : 6/6, 0 to 6, best is 6)

    Measured: Baseline and at 6 months

Secondary outcomes (10)
  1. Microbial Epidemiology

    Distribution by portal of entry in bacteremia and distribution by infectious agent in respiratory infection and bacteremia

    Measured: At 6 months

  2. Functional status depending on the infectious causes.

    Evolution of Basic and instrumental daily life activities (ADL/IADL) depending on the infectious causes (Scores ADL : 6/6, 0 to 6, best is 6 - IADL score: 8/8 from 0 To 8 best is 8)

    Measured: 15 days Before admission, at admission ( whithin 1st day), Up to 10 days, 3 months and 6 months after discharge

  3. Change in Functional status per country and per health care setting

    Measure of the change in the functional status: instrumental daily life activities (ADL/IADL) between hospitalization, discharge, M3 and M6 per country and per health care setting (Scores ADL : 6/6, 0 to 6, best is 6 - IADL score: 8/8 from 0 To 8 best is 8)

    Measured: 15 days Before admission, at admission ( whithin 1st day), Up to 10 days, 3 months and 6 months after discharge

  4. Medical complications

    Number of medical complications between discharge and M6

    Measured: acute phase Up to 6 months

  5. Evolution of Frailty

    Evolution of Clinical Frailty Scale (from 1 to 9 - Best level 1 worst Level 9 )

    Measured: 15 days Before admission, at admission ( whithin 1st day), Up to 10 days, 3 months and 6 months after discharge

  6. Evolution of quality of life

    Evolution of EQ 5D - 3L score ( different conditions 0 to 1)

    Measured: 15 days Before admission, at admission ( whithin 1st day), Up to 10 days, 3 months and 6 months after discharge

  7. Evolution of quality of life depending on the infectious causes.

    Evolution Evolution of EQ 5D - 3L score ( different conditions 0 to 1) depending on infectious causes

    Measured: 15 days Before admission, at admission ( whithin 1st day), Up to 10 days, 3 months and 6 months after discharge]

  8. Evolution of Frailty on depending on the infectious causes.

    Evolution of Clinical Frailty Scale (from 1 to 9 - Best level 1 worst Level 9 )

    Measured: 15 days Before admission, at admission ( whithin 1st day), Up to 10 days, 3 months and 6 months after discharge

  9. Medical complications

    Type of medical complications requiring or not hospitalization between discharge and M6

    Measured: acute phase, Up to 10 days, at 3 months and at 6 months

  10. Change frailty per country and per health care setting

    Measure of the change frailty ( Clinical frailty scale 0-to 9 the best is 0/9)

    Measured: 15 days Before admission, at admission ( whithin 1st day), Up to 10 days, 3 months and 6 months after discharge

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Apr 2021
  2. Study start1 Apr 2021
  3. Primary completion30 Nov 2023
  4. Study completion30 Nov 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
Longitudinal case-control study
Masking
None (open label)
Enrolment
521 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04825132
Sponsor's protocol ID
38RC20.248
Acronym
AEQUI
Status last verified
Jan 2024
First submitted
9 Feb 2021
Last updated
13 Aug 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Veronese N, Polidori MC, Maggi S, Zamora J, Ruiz-Calvo G, Bangert M, Bourron P, Bausch A, Aviles-Hernandez JD, Lopez-Soto A, Padronguillen D, Lanoix JP, Cruz-Jentoft AJ, Gavazzi G; AEQUI study group. Measuring the impact of hospitalization for infectious diseases on the quality of life of older patients in four European countries: the AEQUI longitudinal matched cohort study (2020-2023). Clin Microbiol Infect. 2025 May;31(5):847-854. doi: 10.1016/j.cmi.2025.01.009. Epub 2025 Jan 20.

    PubMed 39842547

Questions about this trial

What is this clinical trial studying?

A study testing Geriatric assessment tools in people with Respiratory Infections in Old Age and Bacteremia, run by University Hospital, Grenoble at 22 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 22 sites in Italy, France, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evolution of Functional dependency (time frame: Baseline and at 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04825132, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2025.

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