Identification, in Patients Admitted to Intensive Care for Severe Influenza Respiratory Infection, of a Predictive Biomarker of Respiratory Distress

Hospices Civils de Lyon11 sites in 1 country227 target enrollmentJanuary 16, 2015

ConditionsInfluenza Severe Respiratory Infection

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Influenza
Sponsor: Hospices Civils de Lyon
Enrollment: 227
Locations: 11
Primary Endpoint: Change in ratio of the partial pressure of oxygen in arterial blood (PaO2) to the inspired oxygen fraction (FiO2), from admission at 7 days post-admission
Status: Completed
Last Updated: 4 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

Influenza is a major cause of morbidity and mortality. The investigators first goal is to evaluate soluble HLA-G5 isoform serum level as a potential marker of greater risk of death from Influenza respiratory illness in adult and pediatric patients hospitalized in reanimation. Secondly, the investigators collected respiratory samples in order to study the transcriptomic profiles of influenza-infected patients with severe symptoms.

Registry

clinicaltrials.gov

Start Date

January 16, 2015

End Date

January 1, 2019

Last Updated

4 months ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Hospices Civils de Lyon

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Patient (Adult or Pediatric)
•Hospitalized in reanimation
•With a laboratory confirmed Influenza
•That agree to take part in the study
•Affiliated to National Health Insurance
•For ancillary group :
•Adult at least 60 years old
•Presenting at hospital for a blood test

Exclusion Criteria

•non willing to participate
•Influenza infection with no respiratory symptoms
•pregnancy
•For ancillary group :
•Presence of immunodepression defined by:
•Cancer, or cancer cured for less than 2 years
•Corticosteroids, Methotrexate (MTX), anti Tumor Necrosis Factor (TNF), anti-CD20
•Infection in progress (fever)

Outcomes

Primary Outcomes

Change in ratio of the partial pressure of oxygen in arterial blood (PaO2) to the inspired oxygen fraction (FiO2), from admission at 7 days post-admission

Time Frame: The first, third, fifth and seventh day of hospitalization in reanimation

decreased arterial PaO2/FiO2 ratio ≤ 100 mmHg (≤ 13.3 kPa)

Secondary Outcomes

All cause mortality(90 days after hospitalization)
Extracorporeal membrane oxygenation requirement(90 days after hospitalization)
SOFA score (Adult) PELOD (Pediatric)(The first, third, fifth and seventh day of hospitalization in reanimation)