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Recruiting NCT06254313

The Role of Cxcr4Hi neutrOPhils in InflueNza

— Observational Influenza Acute Respiratory Distress Syndrome

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Additional tubes and LBA.
Who it may be relevant to
Registry conditions: Influenza, Acute Respiratory Distress Syndrome. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

The Role of CXCR4-expressing Neutrophils in Influenza-related Acute Respiratory Distress Syndrome

Overview

Influenza is still responsible for more than 650,000 deaths per year worldwide and no major improvements in patients' care has been made despite 50 years of research. Especially, there is no therapeutic strategy targeting the dysregulated host response. CXCR4-expressing neutrophils seem to be involved in the rupture of host resistance. The aim of this study is thus to compare the percentage of blood CXCR4-expressing neutrophils between influenza survivors and non-survivors.

Detailed description

Influenza is still responsible for more than 650,000 deaths per year worldwide and no major improvements in patients' care has been made despite 50 years of research. Most of severe influenza patients suffer from acute lung injury due to a dysregulated immune response. Neutrophils are involved in both host resistance and disease tolerance. Thanks to advances in technologies, the vast variety in neutrophils subpopulations has been revealed. In particular, the subpopulation of CXCR4-expressing neutrophils has been suggested to be involved in the rupture of disease tolerance in lung infections. Nevertheless, these data are from murine models and remain to be confirmed in humans. Moreover, the underlying mechanisms remain unknown as well as the place of primum movens, i.e. vascular or alveolar compartment. The aim of this study is thus to compare the percentage of blood CXCR4-expressing neutrophils between influenza survivors and non-survivors. Percentage of BAL CXCR4-expressing neutrophils will also be compared. To this aim, blood sampling and BAL within the 24 hours and at day 3 after admission to ICU, neutrophils isolation, immunostaining and flow cytometry acquisition will be performed within the 24 hours and at day 3 after admission to ICU. Mortality rate will be collected at Day 28 and Day 90.

Interventions

  • Other Additional tubes and LBA
    4 Additional tubes taken when blood is drawn during treatment : EDTA tubes and 2 citrate tubes and bronchoalveolar fluid sample (LBA)

Primary outcome measures

  • Biological [Time frame: Day 1 after inclusion]
  • Clinical [Time frame: Day 28 after inclusion]

Eligibility criteria

Inclusion criteria

  • Patient aged 18 yo or above.
  • Acute respiratory distress syndrome as defined by the Berlin classification.
  • Invasive mechanical ventilation for less than 24 hours.
  • Cause of ARDS:
  • Influenza infection proven by polymerase chain reaction OR
  • Bacterial infection (tracheal aspirate with more than 105 CFU/mL and BAL with more than 104 CFU/mL.
  • Pancreatitis according to the 2013 Working Group IAP/APA Acute Pancreatitis Guidelines.
  • Peritonitis according to the 2018 SFAR guidelines.
  • Health insurance.
  • Written informed consent from legal relative or representative.

Exclusion criteria

  • Neutropenia (< 500/mm3)
  • Neutrophils qualitative defect.
  • Patient included in an interventional research assessing an immunomodulatory or antiviral drug.
  • Acquired ImmunoDeficiency Syndrome.
  • Contraindication to BAL:
  • Severe bronshospasm.
  • Out-of-control shock.
  • Intracranial high pressure.
  • Refractory hypoxemia (PaO2/FiO2 < 60 mmHg).
  • Legal restriction: prisoners, pregnancy, legal protection.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

France · 2 centers
  • Hopital Pellegrin — Bordeaux
  • Hopital Haut-Lévêque — Pessac

Identifiers

NCT: NCT06254313 · CHUBX 2023/41

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗