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

Fever Clinical Trial

— ELISA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04363138
• Other study ID #: 2020-A00301-38
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Bacterial Infections
• C Reactive Protein (CRP) is Less Than 20 mg/ l
• Fever
• Infections
• Leukocytes

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.