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RecruitingNCT06254313CHOPINUpdated Dec 27, 2024

The Role of Cxcr4Hi neutrOPhils in InflueNza

An observational study in Influenza and Acute Respiratory Distress Syndrome, sponsored by University Hospital, Bordeaux. Recruiting at 2 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-12-27.

Sponsored by University Hospital, Bordeaux · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
90
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Influenza
  • Acute Respiratory Distress Syndrome

Keywords

  • neutrophils
  • CXCR4
  • host resistance
  • disease tolerance
03

In context

Influenza, Human

2,214 studies on the registry are indexed under Influenza, Human; 164 are open to participants now.

This study's planned enrollment of 90 is below the median of 300 across 305 observational studies indexed under Influenza, Human.

Browse Influenza, Human studies →

Lead sponsor

University Hospital, Bordeaux is the lead sponsor of 783 studies on the registry; 188 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

The population of interest will be patients with acute respiratory distress syndrome according to the Berlin 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

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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
90 participants (estimated)
Patient registry
No

Groups and cohorts

  • Influenza-related ARDS group

    Person with influenza virus infection proven by a positive polymerase chain reaction test for the influenza ARDS group. Additional tubes taken when blood is drawn during treatment, and bronchoalveolar fluid sample.

    Other: Additional tubes and LBA

  • Bacterial-related ARDS group

    A person with a proven bacterial infection (105 colony-forming units/mL for tracheal aspirates and more than 104 colony-forming units/mL for BAL). Additional tubes taken when blood is drawn during treatment, and bronchoalveolar fluid sample.

    Other: Additional tubes and LBA

  • Extra-pulmonary (digestive inflammation) ARDS group

    Person presenting with acute pancreatitis according to the 2013 international recommendations (typical pain, lipasemia above 3 times normal and/or abnormality on imaging). Or Person presenting with acute bacterial peritonitis based on a clinical diagnosis and bacteria isolated on peritoneal samples (RFE SFAR 2018). Additional tubes taken when blood is drawn during treatment, and bronchoalveolar fluid sample.

    Other: Additional tubes and LBA

Interventions

  • OtherAdditional tubes and LBA

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

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What researchers measure

Primary outcomes

  1. Biological

    Percentage of blood CXCR4-expressing neutrophils within the 24 hours following admission to ICU for invasive mechanical ventilation.

    Time frame: Day 1 after inclusion

  2. Clinical

    Mortality

    Time frame: Day 28 after inclusion

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Study locations

1 of 2 sites recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 27, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06254313
Lead sponsor
University Hospital, Bordeaux
Responsible party
Sponsor
First posted
Feb 12, 2024
Start date
Dec 2024 (estimated)
Primary completion
Dec 2026 (estimated)
Completion
Dec 2026 (estimated)
Last update
Dec 27, 2024

Study contacts

Renaud PREVEL, Dr
Contact
renaud.prevel@u-bordeaux.fr
5 57 87 26 26 ext. +33
Edouard LHOMME, Dr
study chair · Unité de Soutien Méthodologique à la Recherche clinique et épidémiologique du CHU de Bordeaux

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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