Influenza Associated Aspergillosis In-depth Investigation
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
- Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
- Кому может быть актуально
- Состояния в реестре: Influenza With Pneumonia, Invasive Pulmonary Aspergillosis. 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
- Бельгия
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Unraveling the Pathogenesis of Influenza-associated Aspergillosis: a Single-center, Prospective Cohort Pilot Study
Обзор
This trial is aimed to study the immunological and pathological characteristics of influenza versus non-influenza severe community-acquired pneumonia patients in ICU.
Подробное описание
This trial is aimed to study the immunological and pathological characteristics of influenza versus non-influenza severe community-acquired pneumonia patients in ICU, and correlate findings with occurrence of secondary invasive pulmonary aspergillosis infection.
All consecutive patients aged 18 or older admitted to ICU during the inclusion period with respiratory distress due to influenza positive/negative community acquired pneumonia (CAP) will be included.
Первичные конечные точки
- Difference in immune cell profile in blood between influenza and non-influenza CAPIV patients at ICU. [Срок оценки: through study completion, after 3 influenza seasons (3 years)]
- Difference in cytokine production of mononuclear cells to fungal stimulation in blood between influenza and non-influenza CAPIV patients at ICU. [Срок оценки: through study completion, after 3 influenza seasons (3 years)]
- Difference in function of blood neutrophils between influenza and non-influenza CAPIV patients at ICU. [Срок оценки: through study completion, after 3 influenza seasons (3 years)]
- Difference in in immune cell profile in BAL fluid between influenza and non-influenza CAPIV patients at ICU. [Срок оценки: through study completion, after 3 influenza seasons (3 years)]
- Difference in cytokine production of mononuclear cells to fungal stimulation in BAL fluid between influenza and non-influenza CAPIV patients at ICU. [Срок оценки: through study completion, after 3 influenza seasons (3 years)]
- Difference in function of BAL fluid neutrophils between influenza and non-influenza CAPIV patients at ICU. [Срок оценки: through study completion, after 3 influenza seasons (3 years)]
- Difference in pathological hallmarks between influenza and non-influenza CAPIV patients at ICU. [Срок оценки: through study completion, after 3 influenza seasons (3 years)]
Вторичные конечные точки (4)
- Difference in longitudinal alterations in phagocytic cell and mononuclear inflammatory cell subsets in blood and BAL fluid and their response to fungal stimulation between the main study arms. [Срок оценки: through study completion, after 3 influenza seasons (3 years)]
- Longitudinal differences in anatomopathological characteristics of the respiratory tract in CAPIV +/- influenza [Срок оценки: through study completion, after 3 influenza seasons (3 years)]
- Correlation of findings with invasive pulmonary aspergillosis incidence [Срок оценки: through study completion, after 3 influenza seasons (3 years)]
- Correlation of findings with outcome [Срок оценки: through study completion, after 3 influenza seasons (3 years)]
Критерии участия
Критерии включения
- All patients older than 18 years, admitted to ICU with respiratory distress with microbiologically confirmed diagnosis of influenza (for inclusion in the influenza group)
- All patients older than 18 years, admitted to ICU for respiratory distress due to community- acquired pneumonia , with a microbiologically confirmed absence of influenza (for inclusion in the control group)
Критерии исключения
- Age < 18 years old
- Pregnant women
- No informed consent
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
Бельгия · 1 центр
- Universitaire Ziekenhuizen Leuven — Leuven
Идентификаторы
NCT: NCT03748069 · PIAS