Severe Influenza Cohort (ANTIGRIPPE)

November 27, 2025 updated by: Hospices Civils de Lyon

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

227

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bron, France
        • Hôpital Femme Mère Enfant
      • Clermont-Ferrand, France
        • CHU service réanimation adulte
      • Clermont-Ferrand, France
        • CHU service réanimation pédiatrique
      • Dijon, France
        • CHU service réanimation adulte
      • Dijon, France
        • CHU service réanimation pédiatrique
      • Grenoble, France
        • CHU service réanimation adulte
      • Grenoble, France
        • CHU service réanimation pédiatrique
      • Lyon, France
        • Hôpital Edouard Herriot
      • Lyon, 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
      • Pierre-Bénite, France
        • Centre Hospitalier Lyon Sud
      • Saint-Etienne, France
        • CHU Service de Réanimation Adulte
      • Saint-Etienne, France
        • CHU Service de Réanimation Pédiatrique
    • Auvergne-Rhône-Alpes
      • Lyon, Auvergne-Rhône-Alpes, France, 69500
        • Centre de Biologie et de Pathologie Nord

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 month to 99 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
The first, third, fifth and seventh day of hospitalization in reanimation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
All cause mortality
Time Frame: 90 days after hospitalization
90 days after hospitalization
Extracorporeal membrane oxygenation requirement
Time Frame: 90 days after hospitalization
90 days after hospitalization
SOFA score (Adult) PELOD (Pediatric)
Time Frame: The first, third, fifth and seventh day of hospitalization in reanimation
Elevated Score is considered as an evidence of clinical gravity
The first, third, fifth and seventh day of hospitalization in reanimation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Investigators

  • Principal Investigator: Jean-Sebastien CASALEGNO, MD/PhD, HOSPICES CIVILS DE LYON, Virology Department

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 16, 2015

Primary Completion (Actual)

January 1, 2019

Study Completion (Actual)

January 1, 2019

Study Registration Dates

First Submitted

March 4, 2015

First Submitted That Met QC Criteria

March 13, 2015

First Posted (Estimated)

March 19, 2015

Study Record Updates

Last Update Posted (Estimated)

December 4, 2025

Last Update Submitted That Met QC Criteria

November 27, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014-A01023-44

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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