Меню
Идёт набор NCT06254313

The Role of Cxcr4Hi neutrOPhils in InflueNza

— Наблюдательное Influenza Acute Respiratory Distress Syndrome

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Additional tubes and LBA.
Кому может быть актуально
Состояния в реестре: Influenza, Acute Respiratory Distress Syndrome. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Франция
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

  • Другое 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)

Первичные конечные точки

  • Biological [Срок оценки: Day 1 after inclusion]
  • Clinical [Срок оценки: Day 28 after inclusion]

Критерии участия

Критерии включения

  • 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.

Критерии исключения

  • 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Франция · 2 центра
  • Hopital Pellegrin — Bordeaux
  • Hopital Haut-Lévêque — Pessac

Идентификаторы

NCT: NCT06254313 · CHUBX 2023/41

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗