Link Between Eosinopenia and Bacterial Infections in the... | NCT04363138

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

NCT04363138

Sponsor

Gérond'if

Status

Completed

Last Update Posted

Jan 12, 2023Actual

Enrollment

156Actual

Phase

Not provided

Conditions

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

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2, 2021Actual

Primary Completion Date

Aug 1, 2021Actual

Completion Date

Aug 1, 2022Actual

First Submitted Date

Apr 23, 2020

First Submission Date that Met QC Criteria

Apr 24, 2020

First Posted Date

Apr 27, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 11, 2023

Last Update Posted Date

Jan 12, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

156Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
bacterial infection		Patients with bacterial infection
No bacterial infection		Patients without bacterial infection

Interventions

Not provided

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Determine if eosinopenia is associated with the effectiveness of antibiotics by measuring eosinophil counts.		1 month
Determine if the eosinophil counts (PNE) / neutrophil (PNN)x1000 < 4 ratio is associated with a bacterial infection by measuring this value.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

75 Years

Maximum Age

Not provided

Standard Ages

Older Adult

Study Population

Subjects above 75 years of age, hospitalized in geriatrics.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Emmanuelle DURON, MD PhD	Geriatric Department, Paul Brousse Hospital	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Geriatric Department, Paul Brousse Hospital		Villejuif	Île-de-France Region	94800	France

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
38093181	Derived	Mesinele L, Pujol T, Brunetti N, Neiss M, Trivalle C, Souques C, Houenou-Quenum N, Verdier S, Simon P, Vetillard AL, Houdre J, Collarino R, Mary M, Vidal JS, Kahn JE, Guichardon M, Duron E, Baudouin E. Association between low eosinophil count and acute bacterial infection, a prospective study in hospitalized older adults. BMC Geriatr. 2023 Dec 13;23(1):852. doi: 10.1186/s12877-023-04581-y.

ID	Term
D001832	Body Temperature Changes
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms
D001423	Bacterial Infections and Mycoses

ID	Term
D005334	Fever
D001424	Bacterial Infections