Lung Bacteriobiota and Influenza Mortality

Influenza Clinical Trial

— MicroFlu  

Official title:

Association of Lung Bacteriobiota With Intensive Care Unit Mortality in ARDS Patients: MicroFlu Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04131296
• Other study ID #: MicroFlu
• Status: Not yet recruiting
• Start date: December 1, 2019
• Est. completion date: April 30, 2020

Study information

• Verified date: October 2019
• Source: University of Bordeaux
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 64
• Est. completion date: April 30, 2020
• Est. primary completion date: April 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Critical Illness
• Influenza
• Influenza, Human

Intervention

Diagnostic Test:
• influenza screening
positive influenza screening

Locations

Country	Name	City	State
France	Medical intensive care unit, Pellegrin hospital	Bordeaux	Nouvelle-Aquitaine
France	Intensive care unit, CH Robert Boulin	Libourne
France	Intensive care unit, CH Francois Mitterrand	Pau

Sponsors (1)

Lead Sponsor	Collaborator
University of Bordeaux

Country where clinical trial is conducted

France, 

Outcome

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