Clinical trial NCT02392858: Severe Influenza Cohort
Official title: Identification, in Patients Admitted to Intensive Care for Severe Influenza Respiratory Infection, of a Predictive Biomarker of Respiratory Distress
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Influenza
Severe Respiratory Infection
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2015-03-19
Enrollment: 227
Sex: ALL
Minimum age (years): 1
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


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)

Primary outcomes:
measure: 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
timeFrame: The first, third, fifth and seventh day of hospitalization in reanimation
Secondary outcomes:
measure: All cause mortality
timeFrame: 90 days after hospitalization
measure: Extracorporeal membrane oxygenation requirement
timeFrame: 90 days after hospitalization
measure: SOFA score (Adult) PELOD (Pediatric)
timeFrame: The first, third, fifth and seventh day of hospitalization in reanimation
Other outcomes:
Locations:
city: Lyon
country: France
facility: Centre de Biologie et de Pathologie Nord
state: Rhone -alpes
city: Bron
country: France
facility: Hôpital Femme Mère Enfant
city: Clermont Ferrand
country: France
facility: CHU service réanimation adulte
city: Clermont Ferrand
country: France
facility: CHU service réanimation pédiatrique
city: Dijon
country: France
facility: CHU service réanimation adulte
city: Dijon
country: France
facility: CHU service réanimation pédiatrique
city: Grenoble
country: France
facility: CHU service réanimation adulte
city: Grenoble
country: France
facility: CHU service réanimation pédiatrique
city: Lyon
country: France
facility: Centre de Biologie et Pathologie Est
city: Lyon
country: France
facility: Hôpital de la Croix Rousse-service réanimation adulte chirurgicale
city: Lyon
country: France
facility: Hôpital de la Croix Rousse-service réanimation adulte médicale
city: Lyon
country: France
facility: Hôpital Edouard Herriot
city: Pierre Bénite
country: France
facility: Centre Hospitalier Lyon Sud
city: St Etienne
country: France
facility: CHU Service de Réanimation Adulte
city: St Etienne
country: France
facility: CHU Service de Réanimation Pédiatrique
Study officials:
affiliation: HOSPICES CIVILS DE LYON, Virology Department
name: Jean-Sebastien CASALEGNO, MD/PhD
role: PRINCIPAL_INVESTIGATOR
References: