NCT04363138

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
156

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 23, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 27, 2020

Completed
1.2 years until next milestone

Study Start

First participant enrolled

July 2, 2021

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2022

Completed
Last Updated

January 12, 2023

Status Verified

January 1, 2023

Enrollment Period

1 month

First QC Date

April 23, 2020

Last Update Submit

January 11, 2023

Conditions

Keywords

EosinopeniaBacterial infections

Outcome Measures

Primary Outcomes (1)

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

    1 month

Secondary Outcomes (4)

  • 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.

    1 month

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

    1 month

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

    1 month.

Study Arms (2)

bacterial infection

Patients with bacterial infection

No bacterial infection

Patients without bacterial infection

Eligibility Criteria

Age75 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Subjects above 75 years of age, hospitalized in geriatrics.

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Geriatric Department, Paul Brousse Hospital

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

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

FeverBacterial Infections

Condition Hierarchy (Ancestors)

Body Temperature ChangesSigns and SymptomsPathological Conditions, Signs and SymptomsBacterial Infections and MycosesInfections

Study Officials

  • Emmanuelle DURON, MD PhD

    Geriatric Department, Paul Brousse Hospital

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 23, 2020

First Posted

April 27, 2020

Study Start

July 2, 2021

Primary Completion

August 1, 2021

Study Completion

August 1, 2022

Last Updated

January 12, 2023

Record last verified: 2023-01

Locations