NCT04131296

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
64

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2019

Shorter than P25 for all trials

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 16, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 18, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

December 1, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2020

Completed
Last Updated

November 1, 2019

Status Verified

October 1, 2019

Enrollment Period

5 months

First QC Date

October 16, 2019

Last Update Submit

October 31, 2019

Conditions

InfluenzaCritical Illness

Keywords

influenzamicrobiotaintensive care unit

Outcome Measures

Primary Outcomes (1)

  • Lung bacteriobiota and ICU mortality

    Comparison of lung bacteriobiota alpha diversity between influenza ICU survivors and non-survivors

    at admission

Secondary Outcomes (6)

  • Lung bacteriobiota and ICU mortality

    at admission

  • Lung bacteriobiota and 7-day mortality

    at admission

  • Bacteria and ICU mortality

    at admission

  • Bacteria and 7-day mortality

    at admission

  • ICU mortality based on Shannon index

    at admission

  • +1 more secondary outcomes

Interventions

influenza screeningDIAGNOSTIC_TEST

positive influenza screening

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Influenza patients admitted to ICU

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Medical intensive care unit, Pellegrin hospital

Bordeaux, Nouvelle-Aquitaine, 33000, France

Location

Intensive care unit, CH Robert Boulin

Libourne, 33500, France

Location

Intensive care unit, CH Francois Mitterrand

Pau, 64000, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

sputum or tracheal aspirate

MeSH Terms

Conditions

Influenza, HumanCritical Illness

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

October 16, 2019

First Posted

October 18, 2019

Study Start

December 1, 2019

Primary Completion

April 30, 2020

Study Completion

April 30, 2020

Last Updated

November 1, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share

Locations

FR(3)