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NCT02392858 Clinical Trial

Severe Influenza Cohort

Influenza Clinical Trial

— ANTIGRIPPE  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02392858
Other study ID # 2014-A01023-44
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 16, 2015
Est. completion date January 2019

Study information
Verified date February 2019
Source Hospices Civils de Lyon
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 227
Est. completion date January 2019
Est. primary completion date January 2019
Accepts healthy volunteers No
Gender All
Age group 1 Month to 99 Years
Eligibility 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)

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• influenza cohort
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.

Locations
Country Name City State
France Hôpital Femme Mère Enfant Bron
France CHU service réanimation adulte Clermont Ferrand
France CHU service réanimation pédiatrique Clermont Ferrand
France CHU service réanimation adulte Dijon
France CHU service réanimation pédiatrique Dijon
France CHU service réanimation adulte Grenoble
France CHU service réanimation pédiatrique Grenoble
France Centre de Biologie et de Pathologie Nord Lyon Rhone -alpes
France Centre de Biologie et Pathologie Est Lyon
France Hôpital de la Croix Rousse-service réanimation adulte chirurgicale Lyon
France Hôpital de la Croix Rousse-service réanimation adulte médicale Lyon
France Hôpital Edouard Herriot Lyon
France Centre Hospitalier Lyon Sud Pierre Bénite
France CHU Service de Réanimation Adulte St Etienne
France CHU Service de Réanimation Pédiatrique St Etienne

Sponsors (1)
Lead Sponsor Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 decreased arterial PaO2/FiO2 ratio = 100 mmHg (= 13.3 kPa) The first, third, fifth and seventh day of hospitalization in reanimation
Secondary All cause mortality 90 days after hospitalization
Secondary Extracorporeal membrane oxygenation requirement 90 days after hospitalization
Secondary SOFA score (Adult) PELOD (Pediatric) Elevated Score is considered as an evidence of clinical gravity The first, third, fifth and seventh day of hospitalization in reanimation
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