FeverELISANCT04363138
Link Between Eosinopenia and Bacterial Infections in the Elderly Subject Hospitalized in Geriatrics
An observational study of Fever and Leukocytes, run by Gérond'if at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Fever, Leukocytes, C Reactive Protein (CRP) is Less Than 20 mg/ l
- How many people
- 156 participants
- Where
- 1 siteFrance
- Study dates
- 2 Jul 2021to 1 Aug 2022
- 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 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Subjects above 75 years of age, hospitalized in geriatrics.
Who may be able to join
- 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.
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
France1 site
Geriatric Department, Paul Brousse Hospital
Villejuif, Île-de-France Region, 94800
About this study
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.
Read the 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.
- Keywords
- Eosinopenia, Bacterial infections
- Medical subject headings
- Fever, Bacterial Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| bacterial infection | Patients with bacterial infection | |
| No bacterial infection | Patients without bacterial infection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine if eosinopenia is associated with bacterial infections by measuring eosinophil counts.
Measured: 1 month
Secondary outcomes (4)
Determine if eosinopenia is associated with the effectiveness of antibiotics by measuring eosinophil counts.
Measured: 1 month
Determine if the eosinophil counts (PNE) / neutrophil (PNN)x1000 < 4 ratio is associated with a bacterial infection by measuring this value.
Measured: 1 month
Determine if eosinopenia is associated with mortality by measuring eosinophil counts.
Measured: 1 month
Determine if deep eosinopenia is associated with bacterial involvement by measuring if this value is less than 10 per mm3.
Measured: 1 month.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2020
- Study start2 Jul 2021
- Primary completion1 Aug 2021
- Study completion1 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for FeverStudies 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
- Prospective
- Enrolment
- 156 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gérond'if
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emmanuelle DURON, MD PhD, Study chair, Geriatric Department, Paul Brousse Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04363138
- Sponsor's protocol ID
- 2020-A00301-38
- Acronym
- ELISA
- Status last verified
- Jan 2023
- First submitted
- 23 Apr 2020
- Last updated
- 12 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 38093181
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Link Between Eosinopenia and Bacterial Infections in the Elderly Subject Hospitalized in Geriatrics
- ClinicalTrials.gov ID
- NCT04363138
- Acronym / sponsor ID
- ELISA / 2020-A00301-38
- Keywords
- Eosinopenia, Bacterial infections
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 156 participants (actual)
- Lead sponsor
- Gérond'ifUniversity, hospital or other
- Study start
- 2 Jul 2021 (actual)
- Primary completion
- 1 Aug 2021 (actual)
- Study completion
- 1 Aug 2022 (actual)
- First posted
- 27 Apr 2020 (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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| bacterial infection | – | –Patients with bacterial infection |
| No bacterial infection | – | –Patients without bacterial infection |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Subjects above 75 years of age, hospitalized in geriatrics.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (13 listed)
- Immunosuppression (HIV with CD4 <200 / mm3)
- Active corticosteroid therapy
- Asthma
- Chemotherapy, immunosuppressive treatment
- Malignant hematological disease, lympho or myeloproliferative syndrome
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Determine if eosinopenia is associated with bacterial infections by measuring eosinophil counts.
Time frame: 1 month
4 secondary outcomes
Determine if eosinopenia is associated with the effectiveness of antibiotics by measuring eosinophil counts.
Time frame: 1 month
Determine if the eosinophil counts (PNE) / neutrophil (PNN)x1000 < 4 ratio is associated with a bacterial infection by measuring this value.
Time frame: 1 month
Determine if eosinopenia is associated with mortality by measuring eosinophil counts.
Time frame: 1 month
Determine if deep eosinopenia is associated with bacterial involvement by measuring if this value is less than 10 per mm3.
Time frame: 1 month.
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 12 Jan 2023.
- Derived from this study: PubMed 38093181Mesinele 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.
- Individual participant dataSharing planned: Undecided
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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.
Emmanuelle DURON, MD PhD study chair
Geriatric Department, Paul Brousse Hospital
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 Fever and Leukocytes, run by Gérond'if 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 6 inclusion and 13 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 12 Jan 2023. 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?
Determine if eosinopenia is associated with bacterial infections by measuring eosinophil counts. (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04363138, which also lists 1 linked publication.
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 12 Jan 2023.