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Набор скоро начнётся NCT06105814

Improved Diagnostics, Treatment and Follow-up of Acute Exacerbation of Chronic Obstructive Pulmonary Disease

Без фазы С лечением Chronic Obstructive Pulmonary Disease Exacerbation Pneumonia Respiratory Tract Infections

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: Rapid diagnostics.
Кому может быть актуально
Состояния в реестре: Chronic Obstructive Pulmonary Disease Exacerbation, Pneumonia, Respiratory Tract Infections. 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
Список центров уточняется — проверьте первичный протокол.
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

Improved Diagnostics, Treatment and Follow-up of Acute Exacerbation of Chronic Obstructive Pulmonary Disease (COPEXNOR)

Обзор

Chronic obstructive pulmonary disease (COPD) is a chronic and often progressive pulmonary disease, where inflammation and recurrent infections are key pathophysiological contibutors in disease progression. Acute exacerbations of COPD (AECOPD) are often treated with antibiotics, even though only about 50% are caused by bacteria, and the evidence for benefit of empiric antibiotic treatment in AECOPD is conflicting. Microbiological sampling is often insufficient in the setting of AECOPD, and there is a lack of biomarkers distinguishing AECOPD caused by bacteria from those not caused by bacteria, leaving the clinician with few tools to guide the use of antibiotics. Overuse of antibiotics is the main driver of antimicrobial resistance (AMR), a major global public health threat, and obtaining the correct microbiological diagnose is important in guiding treatment of AECOPD. COPEXNOR seeks to examine which samples give the highest microbiological yield in AECOPD, comparing induced sputum to nasopharyngeal swabs. We will also compare conventional microbiological diagnostics to modern rapid molecular microbiological tests, to evaluate if faster microbiological diagnosis improves antibiotic stewardship. The study aims to define the microbiological etiology causing AECOPD in the Norwegian COPD-population, and examine the lung microbiome over time. COPEXNOR will explore biomarkers in sputum and blood that can be useful for differentiating patients who will benefit from antibiotic treatment from patients who will not.

Вмешательства

  • Устройство Rapid diagnostics
    Sputum sampes will in addition to standard diagnostics be investigated using a rapid diagnostic plattform (FilmArray)

Первичные конечные точки

  • Improve microbiological sampling strategies in AECOPD. [Срок оценки: Within months to a year after study completion.]
  • Improve microbiological diagnostic workflow for faster initiation of adequate antibiotic therapy. [Срок оценки: Within months to a year after study completion.]
  • Reduce the use of unnecessary broad antimicrobial therapy. [Срок оценки: Within months to a year after study completion.]
  • Increase knowledge of the microbiological etiology in AECOPD. [Срок оценки: Within months to a year after study completion.]
  • Increased understanding of the lung microbiome over time. [Срок оценки: 2-5 years after study completion]
  • Biomarkers at protein level [Срок оценки: 2-5 years after study completion]
  • Protein markers of the iron metabolism [Срок оценки: 2-5 years after study completion]
  • Biomarkers at the transcriptional level [Срок оценки: 2-5 years after study completion]
  • Biomarkers for predicting outcome [Срок оценки: 2-5 years after study completion]

Критерии участия

Критерии включения

  • Age ≥ 18 years
  • Admitted to the emergency room with a tentative diagnosis of AECOPD, and at least two of the following criteria, more than the daily variation,
  • Increased dyspnea
  • Increased cough
  • Increased sputum production
  • Need for change in medication due to AECOPD
  • Signed informed consent. Among patients with temporal or permanent reduced ability to consent, close relatives and/or family members must be asked and may approve or reject participation on behalf of the patient. In cases where close relatives/family members are not available, study personnel may include patients according to conscious judgment.
  • Patients will be informed about the study and included by dedicated and approved study personnel (study nurses or study doctors), not by the treating health personnel.

Критерии исключения

  • Pulmonary embolism, segmental or larger
  • Refractory septic shock (meeting the Sepsis-3 definition of septic shock, and requiring vasopressors ≥ 0.5 mcg/kg/min noradrenaline or equivalent dose of other vasopressor(s)
  • Glasgow Coma Scale score 3
  • Patients not eligible for lower airways sampling within the first 24 hours of admission
  • Palliative situation with life expectancy < 1 week

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Двойное слепое
Основная цель
Диагностика

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06105814 · DS-INF-COPEXNOR

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗