InfluenzaMicroFluNCT04131296
Lung Bacteriobiota and Influenza Mortality
An observational study of Influenza and Critical Illness, run by University of Bordeaux at 3 sites in France.
Trial summary
Influenza is a potentially lethal disease still responsible for thousands excess deaths both in Europe and the United States. Despite the use of neuraminidase inhibitors, its treatment is mostly based on symptomatic care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Influenza, Critical Illness
- What is being tested?
- influenza screening
- How many people
- 64 participants
- Where
- 3 sitesFrance
- Study dates
- 1 Dec 2019to 30 Apr 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
- No healthy volunteers
- Adult, Older adult
Study population: Influenza patients admitted to ICU
Who may be able to join
- Patient above 18 year-old admitted to intensive care unit
- Influenza diagnosis by PCR or rapid diagnostic test
Who cannot join
- Guardianship or curatorship
- Prisoners
- No health insurance
- No legal representative
Trial locations and contacts
3 sites in 1 country.
France3 sites
Medical intensive care unit, Pellegrin hospital
Bordeaux, New Aquitaine, 33000
Intensive care unit, CH Robert Boulin
Libourne, 33500
Bernard Gauche, MD, bernard.gauche@ch-libourne.fr
Intensive care unit, CH Francois Mitterrand
Pau, 64000
Alexandre Massri, MD, alexandre.massri@ch-pau.fr
About this study
Official title: Association of Lung Bacteriobiota With Intensive Care Unit Mortality in ARDS Patients: MicroFlu Study
Influenza is a potentially lethal disease still responsible for thousands excess deaths both in Europe and the United States. Despite the use of neuraminidase inhibitors, its treatment is mostly based on symptomatic care. Lung microbiota has been shown to be involved in the immunity against influenza and is correlated with lung inflammation in numerous chronic respiratory diseases. We therefore aim to analyse the correlation between lung bacteriobiota and influenza ICU mortality
Read the detailed description
Influenza is a viral disease which is still responsible for thousands of excess deaths par year both in Europe and in the US. Despite the use of neuraminidase inhibitors, its treatment is mostly based on symptomatic care. As lung microbiota is correlated with lung inflammation in numerous chronic respiratory diseases, we hypothesize that lung microbiota would be correlated with influenza outcomes. In a pilot study, we found that lung bacteriobiota but not mycobiota is associated with influenza ICU mortality. We therefore aim to confirm this correlation between lung bacteriobiota and influenza mortality.
- Conditions
- Influenza, Critical Illness
- Being tested
- influenza screening
- Keywords
- influenza, microbiota, intensive care unit
- Medical subject headings
- Influenza, Human, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
influenza screeningDiagnostic test
positive influenza screening
What is being measured
The primary outcome is the main question the study is designed to answer.
Lung bacteriobiota and ICU mortality
Comparison of lung bacteriobiota alpha diversity between influenza ICU survivors and non-survivors
Measured: at admission
Secondary outcomes (6)
Lung bacteriobiota and ICU mortality
Analysis of lung bacteriobiota beta diversity between influenza ICU survivors and non-survivors
Measured: at admission
Lung bacteriobiota and 7-day mortality
Analysis of lung bacteriobiota beta diversity between influenza 7-day survivors and non-survivors
Measured: at admission
Bacteria and ICU mortality
Association of bacteria with influenza ICU mortality by LefSe method
Measured: at admission
Bacteria and 7-day mortality
Association of bacteria with influenza 7-day mortality by LefSe method
Measured: at admission
ICU mortality based on Shannon index
Comparison of ICU mortality based on a threshold of 1.79 for Shannon Index
Measured: at admission
Lung bacteriobiota and 7-day mortality
Comparison of lung bacteriobiota alpha diversity between influenza 7-day survivors and non-survivors
Measured: at admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2019
- Study start1 Dec 2019 (estimated)
- Primary completion30 Apr 2020 (estimated)
- Study completion30 Apr 2020 (estimated)
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
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Pauline Esteves, University of Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04131296
- Sponsor's protocol ID
- MicroFlu
- Acronym
- MicroFlu
- Status last verified
- Oct 2019
- First submitted
- 16 Oct 2019
- Last updated
- 1 Nov 2019
- Results posted
- No
- Data monitoring committee
- 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 1 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of Lung Bacteriobiota With Intensive Care Unit Mortality in ARDS Patients: MicroFlu Study
- ClinicalTrials.gov ID
- NCT04131296
- Acronym / sponsor ID
- MicroFlu / MicroFlu
- Conditions
- Influenza, Critical Illness
- Keywords
- influenza, microbiota, intensive care unit
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- University of BordeauxUniversity, hospital or other
- Study start
- 1 Dec 2019 (estimated)
- Primary completion
- 30 Apr 2020 (estimated)
- Study completion
- 30 Apr 2020 (estimated)
- First posted
- 18 Oct 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.
Influenza is a potentially lethal disease still responsible for thousands excess deaths both in Europe and the United States. Despite the use of neuraminidase inhibitors, its treatment is mostly based on symptomatic care. Lung microbiota has been shown to be involved in the immunity against influenza and is correlated with lung inflammation in numerous chronic respiratory diseases. We therefore aim to analyse the correlation between lung bacteriobiota and influenza ICU mortality
Detailed description
Influenza is a viral disease which is still responsible for thousands of excess deaths par year both in Europe and in the US. Despite the use of neuraminidase inhibitors, its treatment is mostly based on symptomatic care. As lung microbiota is correlated with lung inflammation in numerous chronic respiratory diseases, we hypothesize that lung microbiota would be correlated with influenza outcomes. In a pilot study, we found that lung bacteriobiota but not mycobiota is associated with influenza ICU mortality. We therefore aim to confirm this correlation between lung bacteriobiota and influenza mortality.
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
- Influenza patients admitted to ICU
Key inclusion criteria (2 listed)
- Patient above 18 year-old admitted to intensive care unit
- Influenza diagnosis by PCR or rapid diagnostic test
Key exclusion criteria (4 listed)
- Guardianship or curatorship
- Prisoners
- No health insurance
- No legal representative
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 |
|---|---|---|
| influenza screeningpositive influenza screening | Diagnostic test | – |
Primary outcome
Lung bacteriobiota and ICU mortality
Time frame: at admission
Comparison of lung bacteriobiota alpha diversity between influenza ICU survivors and non-survivors
6 secondary outcomes
Lung bacteriobiota and ICU mortality
Time frame: at admission
Lung bacteriobiota and 7-day mortality
Time frame: at admission
Bacteria and ICU mortality
Time frame: at admission
Bacteria and 7-day mortality
Time frame: at admission
ICU mortality based on Shannon index
Time frame: at admission
Lung bacteriobiota and 7-day mortality
Time frame: at admission
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2019.
- 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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Influenza and Critical Illness, run by University of Bordeaux at 3 sites 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 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: status not confirmed, as of the sponsor's last update on 1 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lung bacteriobiota and ICU mortality (time frame: at admission). 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 1 Nov 2019.