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

January 11, 2023 updated by: Gérond'if
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.

Study Overview

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 Type

Observational

Enrollment (Actual)

156

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Ile-de-France
      • Villejuif, Ile-de-France, France, 94800
        • Geriatric Department, Paul Brousse Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

75 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Subjects above 75 years of age, hospitalized in geriatrics.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
bacterial infection
Patients with bacterial infection
No bacterial infection
Patients without bacterial infection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Determine if eosinopenia is associated with bacterial infections by measuring eosinophil counts.
Time Frame: 1 month
1 month

Secondary Outcome Measures

Outcome Measure
Time Frame
Determine if eosinopenia is associated with the effectiveness of antibiotics by measuring eosinophil counts.
Time Frame: 1 month
1 month
Determine if the eosinophil counts (PNE) / neutrophil (PNN)x1000 < 4 ratio is associated with a bacterial infection by measuring this value.
Time Frame: 1 month
1 month
Determine if eosinopenia is associated with mortality by measuring eosinophil counts.
Time Frame: 1 month
1 month
Determine if deep eosinopenia is associated with bacterial involvement by measuring if this value is less than 10 per mm3.
Time Frame: 1 month.
1 month.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 2, 2021

Primary Completion (Actual)

August 1, 2021

Study Completion (Actual)

August 1, 2022

Study Registration Dates

First Submitted

April 23, 2020

First Submitted That Met QC Criteria

April 24, 2020

First Posted (Actual)

April 27, 2020

Study Record Updates

Last Update Posted (Actual)

January 12, 2023

Last Update Submitted That Met QC Criteria

January 11, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 2020-A00301-38

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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