EmergenciesBIEDNCT04153331
Burden of Influenza at Emergency Department Level : BIED
A study testing Nasal swab in people with Emergencies and Flu, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Seasonal influenza surveillance in France relies on several sources to detect the onset of the epidemic early, as well as to estimate the severity of epidemics and their impact on the health system. However, the data collected do not fully measure the impact of epidemics on the hospital system. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Emergencies, Flu
- What is being tested?
- Nasal swab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,487 participants
- Where
- 1 siteFrance
- Study dates
- 13 Jan 2020to 9 Mar 2020
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 years
- Consultation for a medical cause
Who cannot join
- Consultation for a non-medical cause (trauma...)
- Pregnant, parturient and lactating women
- Persons deprived of their liberty
- Persons of full age who are subject to a legal protection measure
- Persons not affiliated to a social security system
Trial locations and contacts
1 site in 1 country.
About this study
Seasonal influenza surveillance in France relies on several sources to detect the onset of the epidemic early, as well as to estimate the severity of epidemics and their impact on the health system. However, the data collected do not fully measure the impact of epidemics on the hospital system.
Increasing the investigator's knowledge of the impact of influenza on the hospital system, particularly on emergencies, which are the most affected service, is essential to better adapt the resources put in place to care for patients.
The study will allow a better understanding of the influenza burden, by systematically documenting the severe events (i.e. requiring consultations to the Emergency Rooms) that are triggered by influenza but not necessarily reported/recorded as influenza.
- Conditions
- Emergencies, Flu
- Being tested
- Nasal swab
- Medical subject headings
- Emergencies, Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nasal swabOther
Patient included in emergency with a nasal swab
| Study group | Role | What they receive |
|---|---|---|
| Patients admitted to emergency department with medical cause | Experimental | Patient included in emergency with a nasal swab Receives: Other: Nasal swab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of laboratory confirmed influenza among patients admitted to Emergency Room during the influenza season
The proportion of laboratory confirmed influenza cases will be calculated by dividing the number of patients with laboratory confirmed influenza by the total number of patients included
Measured: 1 day (at admission)
Secondary outcomes (4)
Proportion of patients with co-morbidities
to evaluate the proportion of patients consulting emergency department who have co-morbidities according to the result of the virological sampling
Measured: 1 day (at admission)
Proportion of patients with laboratory confirmed influenza and related outcomes
to estimate the proportion of patients with a laboratory confirmed influenza stratified on the emergency department visit outcomes (hospitalization in medicine, hospitalization in intensive care unit or return home) and other covariates
Measured: 1 day (at admission)
Proportion of patients who consult for other causes than influenza
to estimate the proportion of patients with a laboratory confirmed influenza consulting for other causes than influenza
Measured: 1 day (at admission)
Proportion of asymptomatic influenza cases among patients with laboratory confirmed influenza
The proportion asymptomatic influenza cases will be calculated by dividing the number of patients with asymptomatic influenza by the total number of laboratory confirmed influenza
Measured: 1 day (at admission)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2019
- Study start13 Jan 2020
- Primary completion9 Mar 2020
- Study completion9 Mar 2020
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 EmergenciesStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2,487 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Philppe VANHEMS, MD, Principal investigator, Service Hygiène, Epidémiologie et Prévention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04153331
- Sponsor's protocol ID
- 69HCL19_0755
- Acronym
- BIED
- Status last verified
- Jan 2020
- First submitted
- 4 Nov 2019
- Last updated
- 4 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Amour S, Rubio AP, Orsi A, Oppert M, Loebermann M, Del Pozo Vegas C, Tazarourte K, Douplat M, Jacquin L, Icardi G, Walker J, Glass A, Nealon J, Chaves SS; FERS Study Group; Bricout H, Vanhems P. Influenza in Adults Seeking Care at Seven European Emergency Departments: A Prospective Active Surveillance During the 2019-2020 Influenza Season. Influenza Other Respir Viruses. 2024 Nov;18(11):e70040. doi: 10.1111/irv.70040.
PubMed 39568106
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Burden of Influenza at Emergency Department Level : BIED
- ClinicalTrials.gov ID
- NCT04153331
- Acronym / sponsor ID
- BIED / 69HCL19_0755
- Conditions
- Emergencies, Flu
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,487 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 13 Jan 2020 (actual)
- Primary completion
- 9 Mar 2020 (actual)
- Study completion
- 9 Mar 2020 (actual)
- First posted
- 6 Nov 2019 (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.
Seasonal influenza surveillance in France relies on several sources to detect the onset of the epidemic early, as well as to estimate the severity of epidemics and their impact on the health system. However, the data collected do not fully measure the impact of epidemics on the hospital system.
Increasing the investigator's knowledge of the impact of influenza on the hospital system, particularly on emergencies, which are the most affected service, is essential to better adapt the resources put in place to care for patients.
The study will allow a better understanding of the influenza burden, by systematically documenting the severe events (i.e. requiring consultations to the Emergency Rooms) that are triggered by influenza but not necessarily reported/recorded as influenza.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients admitted to emergency department with medical cause | Experimental | Other: Nasal swabPatient included in emergency with a nasal swab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age > 18 years
- Consultation for a medical cause
Key exclusion criteria (5 listed)
- Consultation for a non-medical cause (trauma...)
- Pregnant, parturient and lactating women
- Persons deprived of their liberty
- Persons of full age who are subject to a legal protection measure
- Persons not affiliated to a social security system
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 |
|---|---|---|
| Nasal swabPatient included in emergency with a nasal swab | Other | Patients admitted to emergency department with medical cause |
Primary outcome
Proportion of laboratory confirmed influenza among patients admitted to Emergency Room during the influenza season
Time frame: 1 day (at admission)
The proportion of laboratory confirmed influenza cases will be calculated by dividing the number of patients with laboratory confirmed influenza by the total number of patients included
4 secondary outcomes
Proportion of patients with co-morbidities
Time frame: 1 day (at admission)
Proportion of patients with laboratory confirmed influenza and related outcomes
Time frame: 1 day (at admission)
Proportion of patients who consult for other causes than influenza
Time frame: 1 day (at admission)
Proportion of asymptomatic influenza cases among patients with laboratory confirmed influenza
Time frame: 1 day (at admission)
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 4 Sep 2025.
- Results publication: PubMed 39568106Amour S, Rubio AP, Orsi A, Oppert M, Loebermann M, Del Pozo Vegas C, Tazarourte K, Douplat M, Jacquin L, Icardi G, Walker J, Glass A, Nealon J, Chaves SS; FERS Study Group; Bricout H, Vanhems P. Influenza in Adults Seeking Care at Seven European Emergency Departments: A Prospective Active Surveillance During the 2019-2020 Influenza Season. Influenza Other Respir Viruses. 2024 Nov;18(11):e70040. doi: 10.1111/irv.70040.
- 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.
Philppe VANHEMS, MD principal investigator
Service Hygiène, Epidémiologie et Prévention
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nasal swab in people with Emergencies and Flu, run by Hospices Civils de Lyon 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 2 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 4 Sep 2025. 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?
Proportion of laboratory confirmed influenza among patients admitted to Emergency Room during the influenza season (time frame: 1 day (at admission)). 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 NCT04153331, 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 4 Sep 2025.