Infectious Diseases in Aged Population

NCT04825132 | Completed

• 1 other identifier: 38RC20.248
• Study Type: interventional
• Target: 521
• Locations: 3 countries
• Sites: 22

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.

Conditions

Respiratory Infections in Old Age; Bacteremia

Keywords

functional dependency; quality of life; elderly people; respiratory infection; bacteraemia; disability

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Microbial Epidemiology

  At 6 months

• Functional status depending on the infectious causes.

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

• Change in Functional status per country and per health care setting

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

• Medical complications

  acute phase Up to 6 months

• Evolution of Frailty

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

Study Arms (2)

Bacteremia and/or acute respiratory infection

EXPERIMENTAL

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

Other: Geriatric assessment tools

Without suspicion of infection

ACTIVE COMPARATOR

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.

Other: Geriatric assessment tools

Interventions

Geriatric assessment tools OTHER

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

Bacteremia and/or acute respiratory infection; Without suspicion of infection

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 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).
• 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
• 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 who cannot be contacted in an emergency

Sponsors & Collaborators

• University Hospital, Grenoble: lead

Study Sites (22)

University Hospital Amiens

Amiens, France

Location

Hospital Chambery

Chambéry, France

Location

Groupe Hospitalier Sud Ile de France

Melun, France

Location

Groupement Hospitalier portes de Provence

Montélimar, France

Location

Centre Hospitalier Intercommunal de Villeneuve St Georges.

Paris, France

Location

University Hospital Poitiers

Poitiers, France

Location

CHRU Tours

Tours, France

Location

Policlinico Universitario Bari

Bari, Italy

Location

Unità Operativa Complessa di Geriatria-Camposampiero-ULSS 6

Camposampiero, Italy

Location

S.O.C. Geriatria-Catanzaro

Catanzaro, Italy

Location

Ospedale Civile di Dolo- ULSS 3 "Serenissima"

Dolo, Italy

Location

Ente Ospedaliero Galliera

Genova, Italy

Location

Unità Operativa Complessa di Geriatria-Legnago-ULSS 9

Legnago, Italy

Location

S.C. Geriatria Monza

Monza, Italy

Location

Azienda Ospedaliera Universitaria Policlinico di Palermo

Palermo, Italy

Location

Istituto di Geriatria e Gerontologia-Azienda Ospedaliera di Perugia

Perugia, Italy

Location

UOC Geriatria di Rovigo

Rovigo, Italy

Location

Malattie infettive - Sanremo

Sanremo, Italy

Location

FCRB - Fundació Clínic per a la Recerca Biomèdica

Barcelona, Spain

Location

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

Madrid, Spain

Location

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

Madrid, Spain

Location

Instituto Murciano de Investigación Biosanitaria Virgen de la Arrixaca

Murcia, Spain

Location

Related Publications (1)

• 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.

  PMID: 39842547 RESULT

MeSH Terms

Conditions

Bacteremia; Respiratory Tract Infections; Toxemia

Condition Hierarchy (Ancestors)

Bacterial Infections; Bacterial Infections and Mycoses; Infections; Sepsis; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Longitudinal case-control study

Study Record Dates

• First Submitted: February 9, 2021
• First Posted: April 1, 2021
• Study Start: April 1, 2021
• Primary Completion: November 30, 2023
• Study Completion: November 30, 2023
• Last Updated: August 13, 2025

Record last verified: 2024-01

Locations

FR (7); ES (4); IT (11)