Clinical trial NCT04825132: Infectious Diseases in Aged Population
Official title: Aged European Population QUality of Life in Infectious Diseases
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Respiratory Infections in Old Age
Bacteremia
Keywords: functional dependency
quality of life
elderly people
respiratory infection
bacteraemia
disability
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2021-04-01
Enrollment: 521
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Longitudinal case-control study
Primary purpose: OTHER

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.

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)

Primary outcomes:
measure: Evolution of Functional dependency
timeFrame: Baseline and at 6 months
Secondary outcomes:
measure: Microbial Epidemiology
timeFrame: At 6 months
measure: Functional status depending on the infectious causes.
timeFrame: 15 days Before admission, at admission ( whithin 1st day), Up to 10 days, 3 months and 6 months after discharge
measure: Change in Functional status per country and per health care setting
timeFrame: 15 days Before admission, at admission ( whithin 1st day), Up to 10 days, 3 months and 6 months after discharge
measure: Medical complications
timeFrame: acute phase Up to 6 months
measure: Evolution of Frailty
timeFrame: 15 days Before admission, at admission ( whithin 1st day), Up to 10 days, 3 months and 6 months after discharge
measure: Evolution of quality of life
timeFrame: 15 days Before admission, at admission ( whithin 1st day), Up to 10 days, 3 months and 6 months after discharge
measure: Evolution of quality of life depending on the infectious causes.
timeFrame: 15 days Before admission, at admission ( whithin 1st day), Up to 10 days, 3 months and 6 months after discharge]
measure: Evolution of Frailty on depending on the infectious causes.
timeFrame: 15 days Before admission, at admission ( whithin 1st day), Up to 10 days, 3 months and 6 months after discharge
measure: Medical complications
timeFrame: acute phase, Up to 10 days, at 3 months and at 6 months
measure: Change frailty per country and per health care setting
timeFrame: 15 days Before admission, at admission ( whithin 1st day), Up to 10 days, 3 months and 6 months after discharge
Other outcomes:
Locations:
city: Amiens
country: France
facility: University Hospital Amiens
city: Chambéry
country: France
facility: Hospital Chambery
city: Melun
country: France
facility: Groupe Hospitalier Sud Ile de France
city: Montélimar
country: France
facility: Groupement Hospitalier portes de Provence
city: Paris
country: France
facility: Centre Hospitalier Intercommunal de Villeneuve St Georges.
city: Poitiers
country: France
facility: University Hospital Poitiers
city: Tours
country: France
facility: CHRU Tours
city: Bari
country: Italy
facility: Policlinico Universitario Bari
city: Camposampiero
country: Italy
facility: Unità Operativa Complessa di Geriatria-Camposampiero-ULSS 6
city: Catanzaro
country: Italy
facility: S.O.C. Geriatria-Catanzaro
city: Dolo
country: Italy
facility: Ospedale Civile di Dolo- ULSS 3 "Serenissima"
city: Genova
country: Italy
facility: Ente Ospedaliero Galliera
city: Legnago
country: Italy
facility: Unità Operativa Complessa di Geriatria-Legnago-ULSS 9
city: Monza
country: Italy
facility: S.C. Geriatria Monza
city: Palermo
country: Italy
facility: Azienda Ospedaliera Universitaria Policlinico di Palermo
city: Perugia
country: Italy
facility: Istituto di Geriatria e Gerontologia-Azienda Ospedaliera di Perugia
city: Rovigo
country: Italy
facility: UOC Geriatria di Rovigo
city: Sanremo
country: Italy
facility: Malattie infettive - Sanremo
city: Barcelona
country: Spain
facility: FCRB - Fundació Clínic per a la Recerca Biomèdica
city: Madrid
country: Spain
facility: FIBio-HCSC - Fundación para la Investigación Biomédica del Hospital Clínico San Carlos
city: Madrid
country: Spain
facility: FIBio-HRYC - Fundación para la Investigación Biomédica del Hospital Universitario Ramón y Cajal
city: Murcie
country: Spain
facility: Instituto Murciano de Investigación Biosanitaria Virgen de la Arrixaca
Study officials:
References: