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临床试验/NCT06254313
NCT06254313招募中不适用

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

University Hospital, Bordeaux2 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2024年12月最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
90
试验地点
2
主要终点
Biological

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

Biological

时间窗: Day 1 after inclusion

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

Clinical

时间窗: Day 28 after inclusion

Mortality

次要结局

未报告次要终点

研究者

发起方
University Hospital, Bordeaux
申办方类型
Other
责任方
Sponsor

研究点 (2)

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