Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04734431 |
| Other study ID # |
EOSINOLD |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
January 1, 2018 |
| Est. completion date |
January 1, 2020 |
Study information
| Verified date |
January 2021 |
| Source |
Centre d'Investigation Clinique et Technologique 805 |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
Description:
We performed an observational, retrospective single-center study in a teaching hospital of
Paris area (Ambroise Paré Hospital in Boulogne-Billancourt). The hospital information system
that is routinely completed by healthcare staff for the financing of hospital activity
(Programme de Médicalisation des Systèmes d'Information - PMSI) was used to identify eligible
patients, i.e. those who had been hospitalized in acute geriatrics ward between January 1 and
December 31, 2018 with a diagnosis or a suspicion of bacterial infection. Information about
bacterial infection was then checked in the medical record of the patient. Infections of
interest were pulmonary, urinary, digestive, biliary, cutaneous, cardiac, and central nervous
system infections, as well as bacteremia.
In case of multiple stays over the study period, only the last one was included in the
analysis.
In total, over this 12-month period, we analyzed the stays of patients affected by 126 father
codes (entitled "family" of pathology) which were sometimes broken down into child codes
(pathologies corresponding to these groups).
The database had been declared to the French Authority for Data Protection (Commission
Nationale de l'Informatique et des Libertés - CNIL) via the Assistance Publique - Hôpitaux de
Paris (AP-HP) (whose registration number is the 2216836).
Data were collected retrospectively by a single investigator, from the patient's medical
record on Agfa® Orbis software. The same software made it possible to consult the totality of
the biology, the images as well as the treatments administered throughout the stay.
In this study, eosinopenia is defined by an eosinophil count under 100 eosinophils/mm3 based
on our previous studies.
Considering D0 as the date of the start of diagnosis by a clinician in the hospital, the
other four dates were between D1 and D7.
The patients were separated into two groups: a group of patients who died during
hospitalization and a group of patients released alive from their stay. If the patients were
still hospitalized 30 days after their admission, they were classified in the group of
"living" patients since they had not died on D30.
