- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04363138
Link Between Eosinopenia and Bacterial Infections in the Elderly Subject Hospitalized in Geriatrics (ELISA)
Study Overview
Status
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
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Ile-de-France
-
Villejuif, Ile-de-France, France, 94800
- Geriatric Department, Paul Brousse Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
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
Sponsor
Investigators
- Study Chair: Emmanuelle DURON, MD PhD, Geriatric Department, Paul Brousse Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2020-A00301-38
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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