DeathNCT04734431
Interest of Eosinopenia to Predict In-hospital Mortality Among Elderly Patients
An observational study of Death and Bacterial Infections, run by Centre d'Investigation Clinique et Technologique 805 at 1 site in France.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Death, Bacterial Infections, Elderly Infection
- What is being tested?
- Eosinophil count
- How many people
- 224 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2018to 1 Jan 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Elderly patients admitted in acute geriatrics, independently of their age, for a bacterial infection according to the ICD-10 and medical chart
Who may be able to join
- 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
Who cannot join
- 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
- Discrepancies between the hospital coding of International Classification of Diseases (ICD-10) and the diagnosis of bacterial infection into the medical chart • Patients already on antibiotic therapy for more than 48 hours before the inclusion
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Persistent Eosinopenia is Associated With In-hospital Mortality Among Elderly Patients : Revisiting and Old Forgotten Marker of Infection
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.
Read more
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.
Read the detailed 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.
- Conditions
- Death, Bacterial Infections, Elderly Infection
- Being tested
- Eosinophil count
- Keywords
- eosinopenia, elderly, bacterial infection, outcome, mortality, hospital
- Medical subject headings
- Death, Bacterial Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eosinophil countBiological
Evaluation of the eosinophil count from admission to day 7
| Study group | Role | What they receive |
|---|---|---|
| Survivors | Patients admitted in geriatrics that survived of a bacterial infection after 30 days (still admitted or discharged), and treated by antibiotics. Receives: Biological: Eosinophil count | |
| Death | Deceased individuals admitted for a bacterial infection in geriatrics, despite receiving an antimicrobial therapy. Receives: Biological: Eosinophil count |
What is being measured
The primary outcome is the main question the study is designed to answer.
Risk of mortality at day 30
Evaluate whether eosinopenia during hospitalization was an independent factor of mortality at day 30 of hospitalization
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2021
- Study start1 Jan 2018
- Primary completion31 Dec 2018
- Study completion1 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DeathStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 224 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre d'Investigation Clinique et Technologique 805
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- BENJAMIN DAVIDO, MD, Principal investigator, Hopital Raymond Poincaré
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04734431
- Sponsor's protocol ID
- EOSINOLD
- Status last verified
- Jan 2021
- First submitted
- 29 Jan 2021
- Last updated
- 2 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Persistent Eosinopenia is Associated With In-hospital Mortality Among Elderly Patients : Revisiting and Old Forgotten Marker of Infection
- ClinicalTrials.gov ID
- NCT04734431
- Acronym / sponsor ID
- EOSINOLD
- Conditions
- Death, Bacterial Infections, Elderly Infection
- Keywords
- eosinopenia, elderly, bacterial infection, outcome, mortality, hospital
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 224 participants (actual)
- Lead sponsor
- Centre d'Investigation Clinique et Technologique 805University, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 1 Jan 2020 (actual)
- First posted
- 2 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Survivors | – | Biological: Eosinophil countPatients admitted in geriatrics that survived of a bacterial infection after 30 days (still admitted or discharged), and treated by antibiotics. |
| Death | – | Biological: Eosinophil countDeceased individuals admitted for a bacterial infection in geriatrics, despite receiving an antimicrobial therapy. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Elderly patients admitted in acute geriatrics, independently of their age, for a bacterial infection according to the ICD-10 and medical chart
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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:
- Discrepancies between the hospital coding of International Classification of Diseases (ICD-10) and the diagnosis of bacterial infection into the medical chart • Patients already on antibiotic therapy for more than 48 hours before the inclusion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Eosinophil countEvaluation of the eosinophil count from admission to day 7 | Biological | Death, Survivors |
Primary outcome
Risk of mortality at day 30
Time frame: 30 days
Evaluate whether eosinopenia during hospitalization was an independent factor of mortality at day 30 of hospitalization
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
BENJAMIN DAVIDO, MD principal investigator
Hopital Raymond Poincaré
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Death and Bacterial Infections, run by Centre d'Investigation Clinique et Technologique 805 at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Risk of mortality at day 30 (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2021.