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Severe Influenza Cohort (ANTIGRIPPE)

Primary Purpose

Influenza, Severe Respiratory Infection

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
influenza cohort
Sponsored by
Hospices Civils de Lyon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Influenza

Eligibility Criteria

1 Month - 99 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Centre de Biologie et de Pathologie Nord
  • Hôpital Femme Mère Enfant
  • CHU service réanimation adulte
  • CHU service réanimation pédiatrique
  • CHU service réanimation adulte
  • CHU service réanimation pédiatrique
  • CHU service réanimation adulte
  • CHU service réanimation pédiatrique
  • Centre de Biologie et Pathologie Est
  • Hôpital de la Croix Rousse-service réanimation adulte chirurgicale
  • Hôpital de la Croix Rousse-service réanimation adulte médicale
  • Hôpital Edouard Herriot
  • Centre Hospitalier Lyon Sud
  • CHU Service de Réanimation Adulte
  • CHU Service de Réanimation Pédiatrique

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

influenza cohort

Arm Description

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.

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

All cause mortality
Extracorporeal membrane oxygenation requirement
SOFA score (Adult) PELOD (Pediatric)
Elevated Score is considered as an evidence of clinical gravity

Full Information

First Posted
March 4, 2015
Last Updated
February 18, 2019
Sponsor
Hospices Civils de Lyon
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1. Study Identification

Unique Protocol Identification Number
NCT02392858
Brief Title
Severe Influenza Cohort
Acronym
ANTIGRIPPE
Official Title
Identification, in Patients Admitted to Intensive Care for Severe Influenza Respiratory Infection, of a Predictive Biomarker of Respiratory Distress
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
January 16, 2015 (Actual)
Primary Completion Date
January 2019 (Actual)
Study Completion Date
January 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza, Severe Respiratory Infection

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
227 (Actual)

8. Arms, Groups, and Interventions

Arm Title
influenza cohort
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
influenza cohort
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Description
decreased arterial PaO2/FiO2 ratio ≤ 100 mmHg (≤ 13.3 kPa)
Time Frame
The first, third, fifth and seventh day of hospitalization in reanimation
Secondary Outcome Measure Information:
Title
All cause mortality
Time Frame
90 days after hospitalization
Title
Extracorporeal membrane oxygenation requirement
Time Frame
90 days after hospitalization
Title
SOFA score (Adult) PELOD (Pediatric)
Description
Elevated Score is considered as an evidence of clinical gravity
Time Frame
The first, third, fifth and seventh day of hospitalization in reanimation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Month
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Sebastien CASALEGNO, MD/PhD
Organizational Affiliation
HOSPICES CIVILS DE LYON, Virology Department
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre de Biologie et de Pathologie Nord
City
Lyon
State/Province
Rhone -alpes
ZIP/Postal Code
69500
Country
France
Facility Name
Hôpital Femme Mère Enfant
City
Bron
Country
France
Facility Name
CHU service réanimation adulte
City
Clermont Ferrand
Country
France
Facility Name
CHU service réanimation pédiatrique
City
Clermont Ferrand
Country
France
Facility Name
CHU service réanimation adulte
City
Dijon
Country
France
Facility Name
CHU service réanimation pédiatrique
City
Dijon
Country
France
Facility Name
CHU service réanimation adulte
City
Grenoble
Country
France
Facility Name
CHU service réanimation pédiatrique
City
Grenoble
Country
France
Facility Name
Centre de Biologie et Pathologie Est
City
Lyon
Country
France
Facility Name
Hôpital de la Croix Rousse-service réanimation adulte chirurgicale
City
Lyon
Country
France
Facility Name
Hôpital de la Croix Rousse-service réanimation adulte médicale
City
Lyon
Country
France
Facility Name
Hôpital Edouard Herriot
City
Lyon
Country
France
Facility Name
Centre Hospitalier Lyon Sud
City
Pierre Bénite
Country
France
Facility Name
CHU Service de Réanimation Adulte
City
St Etienne
Country
France
Facility Name
CHU Service de Réanimation Pédiatrique
City
St Etienne
Country
France

12. IPD Sharing Statement

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Severe Influenza Cohort

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