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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04363138
Other study ID # 2020-A00301-38
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 2, 2021
Est. completion date August 1, 2022

Study information

Verified date January 2023
Source Gérond'if
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 156
Est. completion date August 1, 2022
Est. primary completion date August 1, 2021
Accepts healthy volunteers No
Gender All
Age group 75 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
France Geriatric Department, Paul Brousse Hospital Villejuif Ile-de-France

Sponsors (1)

Lead Sponsor Collaborator
Gérond'if

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Determine if eosinopenia is associated with bacterial infections by measuring eosinophil counts. 1 month
Secondary Determine if eosinopenia is associated with the effectiveness of antibiotics by measuring eosinophil counts. 1 month
Secondary Determine if the eosinophil counts (PNE) / neutrophil (PNN)x1000 < 4 ratio is associated with a bacterial infection by measuring this value. 1 month
Secondary Determine if eosinopenia is associated with mortality by measuring eosinophil counts. 1 month
Secondary Determine if deep eosinopenia is associated with bacterial involvement by measuring if this value is less than 10 per mm3. 1 month.
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