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Completed

NCT Number: NCT04363138

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

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.

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Key information

Age range

75 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Geriatric Department, Paul Brousse Hospital

Villejuif, Île-de-France Region, 94800, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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

    Time frame: 1 month

Secondary outcomes

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

    Time frame: 1 month

  2. 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

  3. Determine if eosinopenia is associated with mortality by measuring eosinophil counts.

    Time frame: 1 month

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

    Time frame: 1 month.

Sponsors and collaborators

Lead sponsor

Gérond'if

Other

Registry information

Acronym: ELISA

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Apr 27, 2020
Registry last updated
Jan 12, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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