ELISA: Link Between Eosinopenia and Bacterial Infections in the Elderly Subject Hospitalized in Geriatrics

Sponsor
Gérond'if (Other)
Overall Status
Recruiting
CT.gov ID
NCT04363138
Collaborator
(none)
140
1
21
6.7

Study Details

Study Description

Brief Summary

The main purpose of this monocentric, non-interventional, prospective study carried out in acute geriatrics (UGA) and post-rehabilitation care, is to determine if eosinopenia is associated with bacterial infections.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    It's a monocentric, non-interventional, prospective study carried.

    At inclusion:

    Non-opposition will be collected by the investigator upon entering the Geriatric Unit.

    The investigators will have all the biological and radiological results and will decide whether or not to start antibiotic treatment.

    Patients will be divided into 2 groups: group with bacterial infections and the other with non-bacterial diseases.

    The patient's socio-demographic data, reason for hospitalization, history, BMI, state of dependence (ADL-IADL), MMSE, treatments will be collected. Biological examinations in the phase where an infection is not suspected will also be collected (NFS, ionogram, urea, creatinemia, albumin, pre albumin, CRP, hepatocellular workup. Clinical examination during the episode may be infectious as well that biological and radiological data will be collected as well as the diagnosis made.

    Antibiotic treatment is prescribed will be listed. The blood levels of eosinophils between the two groups will be compared.

    Follow-up at 1 month:

    The effectiveness of antibiotics will be evaluated on the absence of inflammatory syndrome and fever after the recommended antibiotic treatment and the duration of the recommended treatment. Vital status will be collected.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    140 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Link Between Eosinopenia and Bacterial Infections in the Elderly Subject Hospitalized in Geriatrics
    Actual Study Start Date :
    Jul 2, 2021
    Anticipated Primary Completion Date :
    Feb 1, 2023
    Anticipated Study Completion Date :
    Apr 1, 2023

    Arms and Interventions

    Arm Intervention/Treatment
    bacterial infection

    Patients with bacterial infection

    No bacterial infection

    Patients without bacterial infection

    Outcome Measures

    Primary Outcome Measures

    1. Determine if eosinopenia is associated with bacterial infections by measuring eosinophil counts. [1 month]

    Secondary Outcome Measures

    1. Determine if eosinopenia is associated with the effectiveness of antibiotics by measuring eosinophil counts. [1 month]

    2. Determine if the eosinophil counts (PNE) / neutrophil (PNN)x1000 < 4 ratio is associated with a bacterial infection by measuring this value. [1 month]

    3. Determine if eosinopenia is associated with mortality by measuring eosinophil counts. [1 month]

    4. Determine if deep eosinopenia is associated with bacterial involvement by measuring if this value is less than 10 per mm3. [1 month.]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    75 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Hospitalized in Geriatrics.

    • First episode of:

    • Fever> 38 ° motivating the realization of a biological assessment.

    • Or Leukocytes> 10 g / l and C reactive protein (CRP) > 20 mg / l.

    • Be affiliated to a social security scheme.

    • No oral opposition to participation in the study and use of the data.

    Exclusion Criteria:
    • Immunosuppression (HIV with CD4 <200 / mm3)

    • Active corticosteroid therapy

    • Asthma

    • Chemotherapy, immunosuppressive treatment

    • Malignant hematological disease, lympho or myeloproliferative syndrome

    • Antibiotic therapy initiated before entering the geriatric ward

    • Documented parasitosis

    • Eosinophilic vasculitis

    • stroke <30 days

    • Patient already included in another study

    • Patient under guardianship or curatorship

    • Not affiliated with a social security scheme

    • Oral opposition to participation in the study

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Geriatric Department, Paul Brousse Hospital Villejuif Ile-de-France France 94800

    Sponsors and Collaborators

    • Gérond'if

    Investigators

    • Study Chair: Emmanuelle DURON, MD PhD, Geriatric Department, Paul Brousse Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Gérond'if
    ClinicalTrials.gov Identifier:
    NCT04363138
    Other Study ID Numbers:
    • 2020-A00301-38
    First Posted:
    Apr 27, 2020
    Last Update Posted:
    Dec 22, 2021
    Last Verified:
    Dec 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Gérond'if
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Dec 22, 2021