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Infectious Diseases in Aged Population (AEQUI)

Primary Purpose

Respiratory Infections in Old Age, Bacteremia

Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Geriatric assessment tools
Sponsored by
University Hospital, Grenoble
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Respiratory Infections in Old Age focused on measuring functional dependency, quality of life, elderly people, respiratory infection, bacteraemia, disability

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria For Case:

  • 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
  • Patient affiliated to social security insurance

Exclusion Criteria For Case:

  • 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).

Inclusion Criteria For Controls

  • 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

Exclusion Criteria For Controls

  • 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)

Sites / Locations

  • University Hospital AmiensRecruiting
  • Hospital ChamberyRecruiting
  • Groupe Hospitalier Sud Ile de France
  • Groupement Hospitalier portes de Provence
  • Centre Hospitalier Intercommunal de Villeneuve St Georges.
  • University Hospital PoitiersRecruiting
  • CHRU Tours
  • Policlinico Universitario BariRecruiting
  • Unità Operativa Complessa di Geriatria-Camposampiero-ULSS 6Recruiting
  • S.O.C. Geriatria-CatanzaroRecruiting
  • Ospedale Civile di Dolo- ULSS 3 "Serenissima"Recruiting
  • Ente Ospedaliero GallieraRecruiting
  • Unità Operativa Complessa di Geriatria-Legnago-ULSS 9Recruiting
  • S.C. Geriatria MonzaRecruiting
  • Azienda Ospedaliera Universitaria Policlinico di PalermoRecruiting
  • Istituto di Geriatria e Gerontologia-Azienda Ospedaliera di PerugiaRecruiting
  • UOC Geriatria di RovigoRecruiting
  • Malattie infettive - SanremoRecruiting
  • FCRB - Fundació Clínic per a la Recerca BiomèdicaRecruiting
  • FIBio-HCSC - Fundación para la Investigación Biomédica del Hospital Clínico San CarlosRecruiting
  • FIBio-HRYC - Fundación para la Investigación Biomédica del Hospital Universitario Ramón y CajalRecruiting
  • Instituto Murciano de Investigación Biosanitaria Virgen de la ArrixacaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Bacteremia and/or acute respiratory infection

Without suspicion of infection

Arm Description

Hospitalized in a study center (emergency department, infectious disease, internal medicine or geriatric hospital wards…) for with bacteraemia and/or acute respiratory infection

The 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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Microbial Epidemiology
Distribution by portal of entry in bacteremia and distribution by infectious agent in respiratory infection and bacteremia
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)
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)
Medical complications
Number of medical complications between discharge and M6
Evolution of Frailty
Evolution of Clinical Frailty Scale (from 1 to 9 - Best level 1 worst Level 9 )
Evolution of quality of life
Evolution of EQ 5D - 3L score ( different conditions 0 to 1)
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
Evolution of Frailty on depending on the infectious causes.
Evolution of Clinical Frailty Scale (from 1 to 9 - Best level 1 worst Level 9 )
Medical complications
Type of medical complications requiring or not hospitalization between discharge and M6
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)

Full Information

First Posted
February 9, 2021
Last Updated
May 24, 2022
Sponsor
University Hospital, Grenoble
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1. Study Identification

Unique Protocol Identification Number
NCT04825132
Brief Title
Infectious Diseases in Aged Population
Acronym
AEQUI
Official Title
Aged European Population QUality of Life in Infectious Diseases
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2021 (Actual)
Primary Completion Date
April 30, 2023 (Anticipated)
Study Completion Date
April 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Grenoble

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Infections in Old Age, Bacteremia
Keywords
functional dependency, quality of life, elderly people, respiratory infection, bacteraemia, disability

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Longitudinal case-control study
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
1215 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Bacteremia and/or acute respiratory infection
Arm Type
Experimental
Arm Description
Hospitalized in a study center (emergency department, infectious disease, internal medicine or geriatric hospital wards…) for with bacteraemia and/or acute respiratory infection
Arm Title
Without suspicion of infection
Arm Type
Active Comparator
Arm Description
The 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.
Intervention Type
Other
Intervention Name(s)
Geriatric assessment tools
Intervention Description
Multidimensional Prognostic Index (Living status, medications, ADL, IADL, MMSE mental evaluation, ESS pressure sores, chronic disease, nutritional assessment)
Primary Outcome Measure Information:
Title
Evolution of Functional dependency
Description
Change in activities of daily living (ADL) (Scores ADL : 6/6, 0 to 6, best is 6)
Time Frame
Baseline and at 6 months
Secondary Outcome Measure Information:
Title
Microbial Epidemiology
Description
Distribution by portal of entry in bacteremia and distribution by infectious agent in respiratory infection and bacteremia
Time Frame
At 6 months
Title
Functional status depending on the infectious causes.
Description
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)
Time Frame
15 days Before admission, at admission ( whithin 1st day), Up to 10 days, 3 months and 6 months after discharge
Title
Change in Functional status per country and per health care setting
Description
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)
Time Frame
15 days Before admission, at admission ( whithin 1st day), Up to 10 days, 3 months and 6 months after discharge
Title
Medical complications
Description
Number of medical complications between discharge and M6
Time Frame
acute phase Up to 6 months
Title
Evolution of Frailty
Description
Evolution of Clinical Frailty Scale (from 1 to 9 - Best level 1 worst Level 9 )
Time Frame
15 days Before admission, at admission ( whithin 1st day), Up to 10 days, 3 months and 6 months after discharge
Title
Evolution of quality of life
Description
Evolution of EQ 5D - 3L score ( different conditions 0 to 1)
Time Frame
15 days Before admission, at admission ( whithin 1st day), Up to 10 days, 3 months and 6 months after discharge
Title
Evolution of quality of life depending on the infectious causes.
Description
Evolution Evolution of EQ 5D - 3L score ( different conditions 0 to 1) depending on infectious causes
Time Frame
15 days Before admission, at admission ( whithin 1st day), Up to 10 days, 3 months and 6 months after discharge]
Title
Evolution of Frailty on depending on the infectious causes.
Description
Evolution of Clinical Frailty Scale (from 1 to 9 - Best level 1 worst Level 9 )
Time Frame
15 days Before admission, at admission ( whithin 1st day), Up to 10 days, 3 months and 6 months after discharge
Title
Medical complications
Description
Type of medical complications requiring or not hospitalization between discharge and M6
Time Frame
acute phase, Up to 10 days, at 3 months and at 6 months
Title
Change frailty per country and per health care setting
Description
Measure of the change frailty ( Clinical frailty scale 0-to 9 the best is 0/9)
Time Frame
15 days Before admission, at admission ( whithin 1st day), Up to 10 days, 3 months and 6 months after discharge

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria For Case: 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 Patient affiliated to social security insurance Exclusion Criteria For Case: 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). Inclusion Criteria For Controls 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 Exclusion Criteria For Controls 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gaetan GAVAZZI, MD,PhD
Phone
0033(0)476766760
Email
GGavazzi@chu-grenoble.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Saber TOUATI, PhD
Phone
0033(0)476765805
Email
stouati1@chu-grenoble.fr
Facility Information:
Facility Name
University Hospital Amiens
City
Amiens
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean Philippe LANOIX, MD,PhD
Facility Name
Hospital Chambery
City
Chambéry
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emmanuel FORESTIER, MD
Facility Name
Groupe Hospitalier Sud Ile de France
City
Melun
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sylvain DIAMANTIS, MD
Email
sylvain.diamantis@ghsif.fr
Facility Name
Groupement Hospitalier portes de Provence
City
Montélimar
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elodie EDWIGE, MD
Email
elodie.edwige@gh-portesdeprovence.fr
Facility Name
Centre Hospitalier Intercommunal de Villeneuve St Georges.
City
Paris
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pauline CARAUX PAZ, MD
Email
Pauline.caraux-paz@chiv.fr
Facility Name
University Hospital Poitiers
City
Poitiers
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marc PACCALIN, MD, PhD
Facility Name
CHRU Tours
City
Tours
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bertrand FOUGERE, MD
Email
bertrand.fougere@univ-tours.fr
Facility Name
Policlinico Universitario Bari
City
Bari
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carlo Sabbà, MD
Facility Name
Unità Operativa Complessa di Geriatria-Camposampiero-ULSS 6
City
Camposampiero
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sandro Bolzonella, MD
Facility Name
S.O.C. Geriatria-Catanzaro
City
Catanzaro
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Giovanni Ruotolo, MD
Facility Name
Ospedale Civile di Dolo- ULSS 3 "Serenissima"
City
Dolo
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Francesco Bolzetta, MD
Facility Name
Ente Ospedaliero Galliera
City
Genova
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alberto Pilotto, MD
Facility Name
Unità Operativa Complessa di Geriatria-Legnago-ULSS 9
City
Legnago
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Margherita Azzini, MD
Facility Name
S.C. Geriatria Monza
City
Monza
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Giuseppe Bellelli, MD
Facility Name
Azienda Ospedaliera Universitaria Policlinico di Palermo
City
Palermo
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mario Barbagallo, MD
Facility Name
Istituto di Geriatria e Gerontologia-Azienda Ospedaliera di Perugia
City
Perugia
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Virginia Boccardi, MD
Facility Name
UOC Geriatria di Rovigo
City
Rovigo
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pierluigi Dal Santo, MD
Facility Name
Malattie infettive - Sanremo
City
Sanremo
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Giovanni Cenderello, MD
Facility Name
FCRB - Fundació Clínic per a la Recerca Biomèdica
City
Barcelona
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alfons López Soto, MD
Facility Name
FIBio-HCSC - Fundación para la Investigación Biomédica del Hospital Clínico San Carlos
City
Madrid
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pedro Gil Gregorio, MD
Facility Name
FIBio-HRYC - Fundación para la Investigación Biomédica del Hospital Universitario Ramón y Cajal
City
Madrid
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alfonso Cruz-Jentoft, MD
Facility Name
Instituto Murciano de Investigación Biosanitaria Virgen de la Arrixaca
City
Murcie
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Juan Dionisio Avilés, MD

12. IPD Sharing Statement

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Infectious Diseases in Aged Population

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