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Completed

NCT Number: NCT02392858

Severe 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.

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Key information

Conditions

Influenza Infections Influenza, Human Orthomyxoviridae Infections RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Severe Respiratory Infection Virus Diseases

Age range

1 month–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre de Biologie et de Pathologie Nord, Lyon, Auvergne-Rhône-Alpes, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

influenza cohort

Other

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 outcomes

  1. 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)

Secondary outcomes

  1. All cause mortality

    Time frame: 90 days after hospitalization

  2. Extracorporeal membrane oxygenation requirement

    Time frame: 90 days after hospitalization

  3. 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

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

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

Acronym: ANTIGRIPPE

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Mar 19, 2015
Registry last updated
Dec 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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