Severe Influenza Cohort

Not Applicable

Completed

• Conditions: Influenza; Severe Respiratory Infection
• Interventions: Other: influenza cohort

• Registration Number: NCT02392858
• Lead Sponsor: Hospices Civils de Lyon

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2015-01-16
• Study First Submitted: 2015-03-04
• Study First Submitted QC: 2015-03-13
• Study First Posted: 2015-03-19
• Primary Completion: 2019-01
• Study Completion: 2019-01
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-18
• Last Update Posted: 2019-02-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 227

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

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
influenza cohort	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. 1 control group of 30 patients (ancillary study) will be constitued to have reference values of the HLA-G5 marker. Secondly, the investigators collected respiratory samples in order to study the transcriptomic profiles of influenza-infected patients with severe symptoms.

Primary Outcome Measures

Name	Time	Method
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	The first, third, fifth and seventh day of hospitalization in reanimation	decreased arterial PaO2/FiO2 ratio ≤ 100 mmHg (≤ 13.3 kPa)

Secondary Outcome Measures

Name	Time	Method
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	Elevated Score is considered as an evidence of clinical gravity

Trial Locations

Locations (11)

CHU service réanimation pédiatrique; 🇫🇷 Grenoble, France

Hôpital de la Croix Rousse-service réanimation adulte chirurgicale; 🇫🇷 Lyon, France

Hôpital Femme Mère Enfant; 🇫🇷 Bron, France

CHU Service de Réanimation Pédiatrique; 🇫🇷 St Etienne, France

Centre de Biologie et de Pathologie Nord; 🇫🇷 Lyon, Rhone -alpes, France

Centre de Biologie et Pathologie Est; 🇫🇷 Lyon, France

Centre Hospitalier Lyon Sud; 🇫🇷 Pierre Bénite, France

Hôpital de la Croix Rousse-service réanimation adulte médicale; 🇫🇷 Lyon, France

CHU Service de Réanimation Adulte; 🇫🇷 St Etienne, France

Hôpital Edouard Herriot; 🇫🇷 Lyon, France

CHU service réanimation adulte; 🇫🇷 Grenoble, France