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Идёт набор NCT07255430

Airway Microbiome of Patients With Protracted Bacterial Bronchitis

Наблюдательное Protracted Bacterial Bronchitis

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: Protracted Bacterial Bronchitis. Базовые параметры: до 5 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 →
Официальное название

Interaction Between Microbiome, Virome and Host Immunity Response in the Context of Protracted Bacterial Bronchitis

Обзор

This project aims to assess the relationship between the microbiome and virome composition, the immune responses, and the respiratory health of children with protracted bacterial bronchitis (PBB). In addition, we aim to evaluate how the standard treatment with azithromycin interacts with the components of the microbiome, virome and immune biomarkers.

Подробное описание

Protracted Bacterial Bronchitis (PBB) is an often underestimated disease, characterized by a persistent cough for more than four weeks, without other significant underlying symptoms. While generally treatable, it can lead to complications such as recurrent infections and airway damage (bronchiectasis). The reasons why some children develop PBB or subsequent complications while others do not remain unclear. Recent research suggests that an impaired immune response and microbiota dysbiosis may play a key role. This study aims to analyze the microbial and viral composition of the airways in children with PBB, its relationship with inflammation, and the effects of azithromycin. Oropharyngeal swabs will be collected from up to 160 children \<5 years old diagnosed with PBB at UZA in a longitudinal setup during one year. At each routine consultation (five in total) and during an exacerbation episode, three oropharyngeal swabs will be collected from each child. The three swabs will be used to: (1) determine the microbiome composition using next-generation sequencing, (2) identify the virome composition using multiplex qPCR or similar approaches, and (3) quantify immune biomarkers (RNA and protein-level) and culture microbial isolates. These findings will help to better understand the role of the airway microbiome in young children with PBB and identify microorganisms that may have a pathogenic or protective role. Ultimately, this knowledge may contribute to the development of new and effective diagnostics and treatments for PBB from an early age.

Первичные конечные точки

  • Analysis of respiratory microbiome composition [Срок оценки: Baseline, 3 months, 6 months, 9 months, 12 months and during exacerbations]
  • Prevalence of respiratory viruses [Срок оценки: Baseline, 3 months, 6 months, 9 months, 12 months and during exacerbations]
Вторичные конечные точки (3)
  • Immune biomarkers profiling in airway samples [Срок оценки: Baseline, 3 months, 6 months, 9 months, 12 months and during exacerbations]
  • Correlates of respiratory microbiome [Срок оценки: Baseline, 3 months, 6 months, 9 months, 12 months and during exacerbations]
  • Correlates of Protracted Bacterial Bronchitis [Срок оценки: Baseline, 3 months, 6 months, 9 months, 12 months and during exacerbations]

Критерии участия

Критерии включения

  • Children with PBB diagnosis according to case definition
  • Consent form signed by parents or legal guardians

Критерии исключения

  • Comorbidities (HIV, asthma, chronic obstructive pulmonary disease, diabetes)
  • Have had serious illnesses (meningitis, pneumonia, bacteremia, empyema, etc) in the previous three months, identified only at the time of enrollment.
  • Have chronic respiratory conditions at the time of enrollment (non-PBB bronchiectasis not caused by PBB, CF, allergy, etc.).
  • Having received mechanical ventilation.
  • Having been hospitalized or used antibiotics in the previous three months at the time of enrollment.

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
  • Antwerp University Hospital — Edegem

Идентификаторы

NCT: NCT07255430 · BUN B3002025000069

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗