Infectious Diseases in Aged Population

Bacteremia Clinical Trial

— AEQUI  

Official title:

Aged European Population QUality of Life in Infectious Diseases

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04825132
• Other study ID #: 38RC20.248
• Status: Completed
• Phase: N/A
• Start date: April 1, 2021
• Est. completion date: November 30, 2023

Study information

• Verified date: January 2024
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 521
• Est. completion date: November 30, 2023
• Est. primary completion date: November 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Bacteremia
• Communicable Diseases
• Infections
• Respiratory Infections in Old Age
• Respiratory Tract Infections

Intervention

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

Locations

Country	Name	City	State
France	University Hospital Amiens	Amiens
France	Hospital Chambery	Chambéry
France	Groupe Hospitalier Sud Ile de France	Melun
France	Groupement Hospitalier portes de Provence	Montélimar
France	Centre Hospitalier Intercommunal de Villeneuve St Georges.	Paris
France	University Hospital Poitiers	Poitiers
France	CHRU Tours	Tours
Italy	Policlinico Universitario Bari	Bari
Italy	Unità Operativa Complessa di Geriatria-Camposampiero-ULSS 6	Camposampiero
Italy	S.O.C. Geriatria-Catanzaro	Catanzaro
Italy	Ospedale Civile di Dolo- ULSS 3 "Serenissima"	Dolo
Italy	Ente Ospedaliero Galliera	Genova
Italy	Unità Operativa Complessa di Geriatria-Legnago-ULSS 9	Legnago
Italy	S.C. Geriatria Monza	Monza
Italy	Azienda Ospedaliera Universitaria Policlinico di Palermo	Palermo
Italy	Istituto di Geriatria e Gerontologia-Azienda Ospedaliera di Perugia	Perugia
Italy	UOC Geriatria di Rovigo	Rovigo
Italy	Malattie infettive - Sanremo	Sanremo
Spain	FCRB - Fundació Clínic per a la Recerca Biomèdica	Barcelona
Spain	FIBio-HCSC - Fundación para la Investigación Biomédica del Hospital Clínico San Carlos	Madrid
Spain	FIBio-HRYC - Fundación para la Investigación Biomédica del Hospital Universitario Ramón y Cajal	Madrid
Spain	Instituto Murciano de Investigación Biosanitaria Virgen de la Arrixaca	Murcie

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Grenoble

Countries where clinical trial is conducted

France,  Italy,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evolution of Functional dependency	Change in activities of daily living (ADL) (Scores ADL : 6/6, 0 to 6, best is 6)	Baseline and at 6 months
Secondary	Microbial Epidemiology	Distribution by portal of entry in bacteremia and distribution by infectious agent in respiratory infection and bacteremia	At 6 months
Secondary	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)	15 days Before admission, at admission ( whithin 1st day), Up to 10 days, 3 months and 6 months after discharge
Secondary	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)	15 days Before admission, at admission ( whithin 1st day), Up to 10 days, 3 months and 6 months after discharge
Secondary	Medical complications	Number of medical complications between discharge and M6	acute phase Up to 6 months
Secondary	Evolution of Frailty	Evolution of Clinical Frailty Scale (from 1 to 9 - Best level 1 worst Level 9 )	15 days Before admission, at admission ( whithin 1st day), Up to 10 days, 3 months and 6 months after discharge
Secondary	Evolution of quality of life	Evolution of EQ 5D - 3L score ( different conditions 0 to 1)	15 days Before admission, at admission ( whithin 1st day), Up to 10 days, 3 months and 6 months after discharge
Secondary	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	15 days Before admission, at admission ( whithin 1st day), Up to 10 days, 3 months and 6 months after discharge]
Secondary	Evolution of Frailty on depending on the infectious causes.	Evolution of Clinical Frailty Scale (from 1 to 9 - Best level 1 worst Level 9 )	15 days Before admission, at admission ( whithin 1st day), Up to 10 days, 3 months and 6 months after discharge
Secondary	Medical complications	Type of medical complications requiring or not hospitalization between discharge and M6	acute phase, Up to 10 days, at 3 months and at 6 months
Secondary	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)	15 days Before admission, at admission ( whithin 1st day), Up to 10 days, 3 months and 6 months after discharge