NCT04734431

Brief Summary

No biological marker is highly specific of infection and currently available, especially for bacterial infection. The ideal marker would be easy to perform, rapidly, inexpensive, and correlated with the severity and prognosis of the infection. decreased in eosinophil count (EC) is unspecific of a particular clinical picture and may support a systemic inflammation, whereas the deeper the eosinopenia is, the darker is the prognosis in ICU. The duration of eosinopenia is not clearly documented, but it has been recently shown that EC tends to normalization, rapidly after appropriate and effective antimicrobial therapy in case of bacterial infection among adults patients hospitalized in a medicine ward. In the light of this findings, Terradas et al. described that EC returned back to normal between the day 2 or day 3 in survivors, indicating a potential interest as a predictive marker of the evolution among hospitalized patients. To the best of our knowledge, no work has studied eosinopenia as a prognostic marker of mortality during bacterial infections in the elderly patients in a hospital setting. Our study aims to evaluate the prognosis value of the EC in a geriatric unit of tertiary care hospital.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
224

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2018

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

Study Start

First participant enrolled

January 1, 2018

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

January 29, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 2, 2021

Completed
Last Updated

February 2, 2021

Status Verified

January 1, 2021

Enrollment Period

12 months

First QC Date

January 29, 2021

Last Update Submit

January 29, 2021

Conditions

Keywords

eosinopeniaelderlybacterial infectionoutcomemortalityhospital

Outcome Measures

Primary Outcomes (1)

  • Risk of mortality at day 30

    Evaluate whether eosinopenia during hospitalization was an independent factor of mortality at day 30 of hospitalization

    30 days

Study Arms (2)

Survivors

Patients admitted in geriatrics that survived of a bacterial infection after 30 days (still admitted or discharged), and treated by antibiotics.

Biological: Eosinophil count

Death

Deceased individuals admitted for a bacterial infection in geriatrics, despite receiving an antimicrobial therapy.

Biological: Eosinophil count

Interventions

Evaluation of the eosinophil count from admission to day 7

DeathSurvivors

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Elderly patients admitted in acute geriatrics, independently of their age, for a bacterial infection according to the ICD-10 and medical chart

You may qualify if:

  • Eligible patients were hospitalized in acute geriatrics ward between January 1 and December 31, 2018 with a diagnosis of bacterial infection coded in the medical chart and completed by healthcare staff for the financing of hospital activity.
  • Infections of interest were pulmonary, urinary, digestive, biliary, cutaneous, cardiac, and central nervous system infections, as well as bacteremia.
  • A White blood count cell with eosinophil count available at day 0 from admission, day 3 +/-1 day

You may not qualify if:

  • bone and joint infections because of specificities in the management of these infections (e.g. surgical procedures)
  • Disease that could influence the eosinophil count or that could be the cause of diagnostic errors:
  • Acquired immunosuppression: HIV associated with a CD4 count of less than 200/mm\^3, immunosuppressive treatments (corticosteroid therapy at a dose ≥10 mg/d prednisone equivalent, anti-cancer chemotherapy, methotrexate etc.)
  • Previous known haematological disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Benjamin Davido

Garches, 92380, France

Location

MeSH Terms

Conditions

DeathBacterial Infections

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsBacterial Infections and MycosesInfections

Study Officials

  • BENJAMIN DAVIDO, MD

    Hopital Raymond Poincaré

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

January 29, 2021

First Posted

February 2, 2021

Study Start

January 1, 2018

Primary Completion

December 31, 2018

Study Completion

January 1, 2020

Last Updated

February 2, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations