Lung Bacteriobiota and Influenza Mortality (MicroFlu)

October 31, 2019 updated by: Dr Pauline Esteves, University of Bordeaux

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

64

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Nouvelle-Aquitaine
      • Bordeaux, Nouvelle-Aquitaine, France, 33000
        • Medical intensive care unit, Pellegrin hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Influenza patients admitted to ICU

Description

Inclusion Criteria:

  • Patient above 18 year-old admitted to intensive care unit
  • Influenza diagnosis by PCR or rapid diagnostic test

Exclusion Criteria:

  • Guardianship or curatorship
  • Prisoners
  • No health insurance
  • No legal representative

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lung bacteriobiota and ICU mortality
Time Frame: at admission
Comparison of lung bacteriobiota alpha diversity between influenza ICU survivors and non-survivors
at admission

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lung bacteriobiota and ICU mortality
Time Frame: at admission
Analysis of lung bacteriobiota beta diversity between influenza ICU survivors and non-survivors
at admission
Lung bacteriobiota and 7-day mortality
Time Frame: at admission
Analysis of lung bacteriobiota beta diversity between influenza 7-day survivors and non-survivors
at admission
Bacteria and ICU mortality
Time Frame: at admission
Association of bacteria with influenza ICU mortality by LefSe method
at admission
Bacteria and 7-day mortality
Time Frame: at admission
Association of bacteria with influenza 7-day mortality by LefSe method
at admission
ICU mortality based on Shannon index
Time Frame: at admission
Comparison of ICU mortality based on a threshold of 1.79 for Shannon Index
at admission
Lung bacteriobiota and 7-day mortality
Time Frame: at admission
Comparison of lung bacteriobiota alpha diversity between influenza 7-day survivors and non-survivors
at admission

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Bordeaux

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

December 1, 2019

Primary Completion (Anticipated)

April 30, 2020

Study Completion (Anticipated)

April 30, 2020

Study Registration Dates

First Submitted

October 16, 2019

First Submitted That Met QC Criteria

October 17, 2019

First Posted (Actual)

October 18, 2019

Study Record Updates

Last Update Posted (Actual)

November 1, 2019

Last Update Submitted That Met QC Criteria

October 31, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MicroFlu

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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