Influenza, HumanNCT04244500
Burden of Influenza at Emergency Department (ED) Level in European Countries
An observational study of Influenza, Human, run by University of Rostock at 1 site in Germany.
Trial summary
This study plans to conduct enhanced influenza surveillance at a hospital emergency department level independent of underlying influenza-like symptoms. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Influenza, Human
- What is being tested?
- swab sampling
- Type of treatment
- Surgery or procedure
- How many people
- 2,500 participants
- Where
- 1 siteGermany
- Study dates
- 27 Jan 2020to Aug 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: patients seeking care at the emergency department of participating hospitals
Who may be able to join
- All adult patients seeking care at participating ED during the influenza season
- Participants and/or guardian providing informed consent and/or assent, as appropriate, to participate.
Who cannot join
- Individuals reporting having suffered a traumatic injury without other conditions.
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
University of Rostock
Rostock, 18057
Martin Bienengraeber, Dr., +49381494 5031, dekanat.forschung@med.uni-rostock.de
Micha Loebermann, PD Dr.
About this study
This study plans to conduct enhanced influenza surveillance at a hospital emergency department level independent of underlying influenza-like symptoms.
Read the detailed description
Study objectives
Primary:
- Measure the proportion of non-traumatic emergency department (ED) visits infected with influenza during the peak of the influenza season
Secondary:
- Describe the demographic and medical profile of influenza-related and non-influenza-related visits
- Identify socio-demographic or other risk factors associated with ED visit outcome
- Describe the influenza positivity rate among ED visits for different causes
- Measure the proportion of influenza positive patients without classical ILI symptoms
- Conditions
- Influenza, Human
- Being tested
- swab sampling
- Keywords
- emergency room, epidemiology
- Medical subject headings
- Influenza, Human, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
swab samplingProcedure or surgery
Multiplex polymerase chain reaction assay for organisms of upper respiratory tract infections
| Study group | Role | What they receive |
|---|---|---|
| Influenza | Influenza testing Receives: Procedure: swab sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
influenza status at admission to ED (positive vs. negative)
proportion of non-traumatic emergency department (ED) visits infected with influenza during the peak of the influenza season
Measured: at admission to ED
Secondary outcomes (3)
demographic and medical profile
demographic and medical profile of influenza-related and non-influenza-related visits
Measured: at admission to ED
socio-demographic or other risk factors
Identify socio-demographic or other risk factors associated with ED visit outcome
Measured: at admission to ED
influenza without classical symptoms of influenza-like illness
Measure the proportion of influenza positive patients without classical ILI symptoms
Measured: at admission to ED
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2020
- Study start27 Jan 2020
- Primary completionApr 2020 (estimated)
- Study completionAug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Influenza, HumanStudies 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
- 2,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Rostock
- Sponsor type
- University, hospital or other
- Collaborators
- Klinikum Ernst von Bergmann Potsdam, Klinikum Suedstadt, Rostock, Sanofi Pasteur, a Sanofi Company
- Responsible party
- Principal investigator, Dr. med. Micha Loebermann, University of Rostock
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04244500
- Sponsor's protocol ID
- UMR893958
- Status last verified
- Jan 2020
- First submitted
- 12 Jan 2020
- Last updated
- 28 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Burden of Influenza at Emergency Department (ED) Level in European Countries
- ClinicalTrials.gov ID
- NCT04244500
- Acronym / sponsor ID
- UMR893958
- Conditions
- Influenza, Human
- Keywords
- emergency room, epidemiology
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,500 participants (estimated)
- Lead sponsor
- University of RostockUniversity, hospital or other
- Collaborators
- Klinikum Ernst von Bergmann Potsdam, Klinikum Suedstadt, Rostock, Sanofi Pasteur, a Sanofi Company
- Study start
- 27 Jan 2020 (actual)
- Primary completion
- Apr 2020 (estimated)
- Study completion
- Aug 2020 (estimated)
- First posted
- 28 Jan 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.
This study plans to conduct enhanced influenza surveillance at a hospital emergency department level independent of underlying influenza-like symptoms.
Detailed description
Study objectives
Primary:
- Measure the proportion of non-traumatic emergency department (ED) visits infected with influenza during the peak of the influenza season
Secondary:
- Describe the demographic and medical profile of influenza-related and non-influenza-related visits
- Identify socio-demographic or other risk factors associated with ED visit outcome
- Describe the influenza positivity rate among ED visits for different causes
- Measure the proportion of influenza positive patients without classical ILI symptoms
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Influenza | – | Procedure: swab samplingInfluenza testing |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- patients seeking care at the emergency department of participating hospitals
Key inclusion criteria (2 listed)
- All adult patients seeking care at participating ED during the influenza season
- Participants and/or guardian providing informed consent and/or assent, as appropriate, to participate.
Key exclusion criteria (1 listed)
- Individuals reporting having suffered a traumatic injury without other conditions.
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 |
|---|---|---|
| swab samplingMultiplex polymerase chain reaction assay for organisms of upper respiratory tract infections | Procedure or surgery | Influenza |
Primary outcome
influenza status at admission to ED (positive vs. negative)
Time frame: at admission to ED
proportion of non-traumatic emergency department (ED) visits infected with influenza during the peak of the influenza season
3 secondary outcomes
demographic and medical profile
Time frame: at admission to ED
socio-demographic or other risk factors
Time frame: at admission to ED
influenza without classical symptoms of influenza-like illness
Time frame: at admission to ED
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2020.
- 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.
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 Influenza, Human, run by University of Rostock at 1 site in Germany.
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 1 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: status not confirmed, as of the sponsor's last update on 28 Jan 2020. 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 Germany. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Martin Bienengraeber, Dr. (+49 381 494 5031, dekanat.forschung@med.uni-rostock.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
influenza status at admission to ED (positive vs. negative) (time frame: at admission to ED). 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 28 Jan 2020.