InfluenzaNCT02846311
Evaluation of the Alere i Influenza A&B Nucleic Acid Amplification Versus Xpert Flu/RSV
An observational study of Influenza, run by Fondation Hôpital Saint-Joseph at 1 site in France.
Trial summary
The rapid and accurate detection of influenza virus in respiratory specimens is required for optimal management of patients with acute respiratory infections. Because of the variability of the symptoms and the numerous other causes of influenza-like illness, the diagnosis of influenza cannot be made on the basis of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Influenza
- What is being tested?
- Flu Test
- Type of treatment
- Medical device
- How many people
- 92 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2015to Apr 2015
- 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
- No healthy volunteers
- Adult, Older adult
Study population: adult patients (> 18 years) consultant to the ER for influenza-like illness involving
Who may be able to join
- Respiratory Symptoms include cough, dyspnea and / or
- General symptoms: headache, myalgia, asthenia, anorexia ... and / or
- Acute fever above 38 ° C
- Patient consent.
Who cannot join
- Major cognitive disorders
- Patient under guardianship
- Patient refusing to consent to research
- Duplicate (patients who have had laboratory diagnosis of influenza in previous 7 days)
- Patient not receiving social security
Trial locations and contacts
1 site in 1 country.
France1 site
Groupe Hospitalier Paris Saint Joseph
Paris, Île-de-France Region, 75014
About this study
Official title: Prospective Evaluation of the Alere i Influenza A&B Nucleic Acid Amplification Versus Xpert Flu/RSV
The rapid and accurate detection of influenza virus in respiratory specimens is required for optimal management of patients with acute respiratory infections. Because of the variability of the symptoms and the numerous other causes of influenza-like illness, the diagnosis of influenza cannot be made on the basis of clinical criteria alone. Thus, rapid influenza diagnostic tests have been developed such as the Alere i Influenza A\&B isothermal nucleic acid assay. Investigators prospectively evaluated the performance of the Alere i Influenza A\&B assay in comparison with the routine Xpert Flu/RSV assay.
Read the detailed description
Main objective / secondary:
It appears that so far the weight of the influenza disease, the limits of clinical diagnosis and validity of rapid diagnostic methods to emergencies are well studied and validated. However the potential organizational and economic benefit in emergency care services remains little known and rarely evaluated.
The significant improvement in diagnostic response time he has a real beneficial impact for the patient? For the organization of the emergency? Investigators propose to study the impact of the implementation of rapid diagnostic solution by molecular biology of influenza directly available in an adult emergency department, from a cohort of patients consulting in connection a flu-like illness. Investigators wish in particular to highlight the organizational and economic impact.
Methodology :
DESIGN:
Study single-center, prospective, descriptive, observational, type "before / after".
Unable to reasonably perform a prospective randomized study due to the constraints for patients and for the service and means that it would be necessary to deploy in this case (CRA ... PHRC), Methodology :
DESIGN:
Study single-center, prospective, descriptive, observational, type "before / after".
Unable to reasonably perform a prospective randomized study due to the constraints for patients and for the service and means that it would be necessary to deploy in this case (CRA ... PHRC), we are moving more towards a comparison study before / after between February and April.
Time study Total study duration: 3 months Inclusion period: 3 months (February 2016- April 2016)
Acquisition of data:
Data Observing Notebook (CRF or "Case Report Form") are disclosed in the notes accompanying this document and will be collected aur an Excel spreadsheet Statistical analysis ( For each subject will be awarded an identifier (original name and surname - year of birth) and the data will be entered on a computer file which will be sent to the statistician in charge of analyzing the GHPSJ site. There will be no exchange of personal data for this study is single center on the site GHPSJ.
Development of the study:
The patient presents to the Emergency Home Service for a "flu syndrome". During the first phase ( "before"), the assumption will be that usually achieved.
During the second phase ( "after"), a flu test is routinely performed within the home emergency department by the doctor who supports the patient.
In both cases, the doctor continues to support according to information it has and according to good practice and service protocols.
A case report form (CRF or Case Report Form) is completed for each patient included in the study. This report forms includes a questionnaire that collects anonymous demographic information (patient age and sex) and clinical data. The CRF also includes the results of the rapid test for influenza. These notebooks anonymous comments are seized by the Home Emergency Service on a type of database "Access" (which will then be completed by the results of the rapid test. If positive, strain characterization will be clarified.
Number of patients recruited (justification) and duration of participation for each patient:
Not applicable as observational study are moving more towards a comparison study before / after between February and April.
Time study Total study duration: 3 months Inclusion period: 3 months (February 2016- April 2016)
- Conditions
- Influenza
- Being tested
- Flu Test
- Keywords
- test, winter, season
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flu TestDevice
| Study group | Role | What they receive |
|---|---|---|
| Group with support that will be usually performed | During the first phase ("before"), the assumption will be that usually achieved. The doctor continues to support according to information it has and according to good practice and service protocols. | |
| Group with a flu test | During the second phase ("after"), a flu test is routinely performed within the home emergency department by the doctor who supports the patient.
The doctor continues to support according to information it has and according to good practice and service protocols. Receives: Device: Flu Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of change of the Length of stay in the emergency service
Will be assessed with patients of the firt group (phase 1) and the second one (With Flu Test)
Measured: Day 1
Assessment of change of Hospitalization rates
Will be assessed with patients of the firt group (phase 1) and the second one (With Flu Test)
Measured: Day 1
Secondary outcomes (1)
Assessments of change of antibiotic treatment Costs
Will be assessed with patients of the firt group (phase 1) and the second one (With Flu Test)
Measured: Day1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2016 (estimated)
- Study startJan 2015
- Primary completionApr 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfluenzaStudies 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
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Hôpital Saint-Joseph
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- TRABATTONI Eloïse, MD, Principal investigator, Fondation Hôpital Saint-Joseph
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02846311
- Sponsor's protocol ID
- Test iFluA&B
- Status last verified
- Jul 2016
- First submitted
- 20 Jul 2016
- Last updated
- 27 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of the Alere i Influenza A&B Nucleic Acid Amplification Versus Xpert Flu/RSV
- ClinicalTrials.gov ID
- NCT02846311
- Acronym / sponsor ID
- Test iFluA&B
- Conditions
- Influenza
- Keywords
- test, winter, season
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Fondation Hôpital Saint-JosephUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 27 Jul 2016 (estimated)
- 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 rapid and accurate detection of influenza virus in respiratory specimens is required for optimal management of patients with acute respiratory infections. Because of the variability of the symptoms and the numerous other causes of influenza-like illness, the diagnosis of influenza cannot be made on the basis of clinical criteria alone. Thus, rapid influenza diagnostic tests have been developed such as the Alere i Influenza A\&B isothermal nucleic acid assay. Investigators prospectively evaluated the performance of the Alere i Influenza A\&B assay in comparison with the routine Xpert Flu/RSV assay.
Detailed description
Main objective / secondary:
It appears that so far the weight of the influenza disease, the limits of clinical diagnosis and validity of rapid diagnostic methods to emergencies are well studied and validated. However the potential organizational and economic benefit in emergency care services remains little known and rarely evaluated.
The significant improvement in diagnostic response time he has a real beneficial impact for the patient? For the organization of the emergency? Investigators propose to study the impact of the implementation of rapid diagnostic solution by molecular biology of influenza directly available in an adult emergency department, from a cohort of patients consulting in connection a flu-like illness. Investigators wish in particular to highlight the organizational and economic impact.
Methodology :
DESIGN:
Study single-center, prospective, descriptive, observational, type "before / after".
Unable to reasonably perform a prospective randomized study due to the constraints for patients and for the service and means that it would be necessary to deploy in this case (CRA ... PHRC), Methodology :
DESIGN:
Study single-center, prospective, descriptive, observational, type "before / after".
Unable to reasonably perform a prospective randomized study due to the constraints for patients and for the service and means that it would be necessary to deploy in this case (CRA ... PHRC), we are moving more towards a comparison study before / after between February and April.
Time study Total study duration: 3 months Inclusion period: 3 months (February 2016- April 2016)
Acquisition of data:
Data Observing Notebook (CRF or "Case Report Form") are disclosed in the notes accompanying this document and will be collected aur an Excel spreadsheet Statistical analysis ( For each subject will be awarded an identifier (original name and surname - year of birth) and the data will be entered on a computer file which will be sent to the statistician in charge of analyzing the GHPSJ site. There will be no exchange of personal data for this study is single center on the site GHPSJ.
Development of the study:
The patient presents to the Emergency Home Service for a "flu syndrome". During the first phase ( "before"), the assumption will be that usually achieved.
During the second phase ( "after"), a flu test is routinely performed within the home emergency department by the doctor who supports the patient.
In both cases, the doctor continues to support according to information it has and according to good practice and service protocols.
A case report form (CRF or Case Report Form) is completed for each patient included in the study. This report forms includes a questionnaire that collects anonymous demographic information (patient age and sex) and clinical data. The CRF also includes the results of the rapid test for influenza. These notebooks anonymous comments are seized by the Home Emergency Service on a type of database "Access" (which will then be completed by the results of the rapid test. If positive, strain characterization will be clarified.
Number of patients recruited (justification) and duration of participation for each patient:
Not applicable as observational study are moving more towards a comparison study before / after between February and April.
Time study Total study duration: 3 months Inclusion period: 3 months (February 2016- April 2016)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group with support that will be usually performed | – | –During the first phase ("before"), the assumption will be that usually achieved. The doctor continues to support according to information it has and according to good practice and service protocols. |
| Group with a flu test | – | Device: Flu TestDuring the second phase ("after"), a flu test is routinely performed within the home emergency department by the doctor who supports the patient. The doctor continues to support according to information it has and according to good practice and service protocols. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- adult patients (> 18 years) consultant to the ER for influenza-like illness involving
Key inclusion criteria (4 listed)
- Respiratory Symptoms include cough, dyspnea and / or
- General symptoms: headache, myalgia, asthenia, anorexia ... and / or
- Acute fever above 38 ° C
- Patient consent.
Key exclusion criteria (5 listed)
- Major cognitive disorders
- Patient under guardianship
- Patient refusing to consent to research
- Duplicate (patients who have had laboratory diagnosis of influenza in previous 7 days)
- Patient not receiving social security
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 |
|---|---|---|
| Flu Test | Device | Group with a flu test |
Primary outcome
Assessment of change of the Length of stay in the emergency service
Time frame: Day 1
Will be assessed with patients of the firt group (phase 1) and the second one (With Flu Test)
Assessment of change of Hospitalization rates
Time frame: Day 1
Will be assessed with patients of the firt group (phase 1) and the second one (With Flu Test)
1 secondary outcome
Assessments of change of antibiotic treatment Costs
Time frame: Day1
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 27 Apr 2023.
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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.
TRABATTONI Eloïse, MD principal investigator
Fondation Hôpital Saint-Joseph
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, run by Fondation Hôpital Saint-Joseph 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 4 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 27 Apr 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?
Assessment of change of the Length of stay in the emergency service (time frame: Day 1). The study lists 2 primary outcomes in all. 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 27 Apr 2023.