Lung Bacteriobiota and Influenza Mortality

• Conditions: Critical Illness; Influenza

• Registration Number: NCT04131296
• Lead Sponsor: University of Bordeaux

Brief 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

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 Timeline

• Status Verified: 2019-10
• Study First Submitted: 2019-10-16
• Study First Submitted QC: 2019-10-17
• Study First Posted: 2019-10-18
• Last Update Submitted: 2019-10-31
• Last Update Posted: 2019-11-01
• Study Start: 2019-12-01
• Primary Completion: 2020-04-30
• Study Completion: 2020-04-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 64

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Lung bacteriobiota and ICU mortality	at admission	Comparison of lung bacteriobiota alpha diversity between influenza ICU survivors and non-survivors

Secondary Outcome Measures

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

Trial Locations

Locations (3)

Intensive care unit, CH Robert Boulin; 🇫🇷 Libourne, France

Intensive care unit, CH Francois Mitterrand; 🇫🇷 Pau, France

Medical intensive care unit, Pellegrin hospital; 🇫🇷 Bordeaux, Nouvelle-Aquitaine, France