FluNCT03293979
Alere i FluA*B Biologic Test Relocated in Emergency Service for Flu Diagnosis
An observational study of Flu, run by Fondation Hôpital Saint-Joseph at 1 site in France.
Trial summary
It appears that the heavyness of flu pathology, the diagnosis limits and the validity of it was well studied in the last years.However, the economical impact and the organisation benefit in emergency service is not yet evaluated Our purpose is to study the impact of implementation of fast flu diagnosis by molecular… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Flu
- What is being tested?
- Test A i Flu A&B implemented in emergency service
- How many people
- 301 participants
- Where
- 1 siteFrance
- Study dates
- 22 Jan 2016to 30 Jun 2018
- 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: each patient admitted in emergy service between february 2016 and april 2016
Who may be able to join
- respiratory symptoms
- fever >38°C
- general symptoms of flu like pathology
Who cannot join
- cognitive disorders
- patient with guardianship
- patient already having a flu diagnosis in the last 7 days
- without social protection.
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
It appears that the heavyness of flu pathology, the diagnosis limits and the validity of it was well studied in the last years.However, the economical impact and the organisation benefit in emergency service is not yet evaluated Our purpose is to study the impact of implementation of fast flu diagnosis by molecular biology available in emergency service in the economic field .
- Conditions
- Flu
- Being tested
- Test A i Flu A&B implemented in emergency service
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Test A i Flu A&B implemented in emergency serviceDiagnostic test
Test A i Flu A\&B implemented in emergency service
What is being measured
The primary outcome is the main question the study is designed to answer.
time to have the result of the biological test
Measured: 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2017
- Study start22 Jan 2016
- Primary completion31 Dec 2016
- Study completion30 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FluStudies 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
- 301 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Hôpital Saint-Joseph
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- GANANSIA Olivier, MD, Principal investigator, GHPSJ
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03293979
- Sponsor's protocol ID
- TestAiFluA&B
- Status last verified
- Aug 2018
- First submitted
- 21 Sep 2017
- Last updated
- 9 Aug 2018
- Results posted
- 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 9 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alere i FluA*B Biologic Test Relocated in Emergency Service for Flu Diagnosis
- ClinicalTrials.gov ID
- NCT03293979
- Acronym / sponsor ID
- TestAiFluA&B
- Conditions
- Flu
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 301 participants (actual)
- Lead sponsor
- Fondation Hôpital Saint-JosephUniversity, hospital or other
- Study start
- 22 Jan 2016 (actual)
- Primary completion
- 31 Dec 2016 (actual)
- Study completion
- 30 Jun 2018 (actual)
- First posted
- 26 Sep 2017 (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.
It appears that the heavyness of flu pathology, the diagnosis limits and the validity of it was well studied in the last years.However, the economical impact and the organisation benefit in emergency service is not yet evaluated Our purpose is to study the impact of implementation of fast flu diagnosis by molecular biology available in emergency service in the economic field .
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- each patient admitted in emergy service between february 2016 and april 2016
Key inclusion criteria (3 listed)
- respiratory symptoms
- fever >38°C
- general symptoms of flu like pathology
Key exclusion criteria (4 listed)
- cognitive disorders
- patient with guardianship
- patient already having a flu diagnosis in the last 7 days
- without social protection.
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 |
|---|---|---|
| Test A i Flu A&B implemented in emergency serviceTest A i Flu A\&B implemented in emergency service | Diagnostic test | – |
Primary outcome
time to have the result of the biological test
Time frame: 3 hours
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 9 Aug 2018.
- Individual participant dataSharing planned: No
Related trials for Flu
Not yet recruitingPhase 2/3
Evaluation of the Efficacy and Safety of 102D-6 in the Treatment of Acute Uncomplicated Influenza
Influenza, Human
RecruitingPhase 2
COVID-19 Booster and IIV Schedule in Immunocompromised Hosts
COVID 19, Influenza
Not yet recruiting
Family Physician Nudges for Influenza Vaccination Among Older Adults
Influenza Vaccination
Recruiting
Light-based Immunomodulation for Guarding Against Human Respiratory Tract Infections
COVID-19 Respiratory Infection, Influenza
RecruitingPhase 2
BPL-1357 Against H1N1 Influenza Virus Challenge
Influenza, Human
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.
GANANSIA Olivier, MD principal investigator
GHPSJ
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 Flu, 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 3 inclusion and 4 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 9 Aug 2018. 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?
time to have the result of the biological test (time frame: 3 hours). 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 9 Aug 2018.