Меню
Идёт набор NCT07369414

Environmental Reservoirs of Non-tuberculous Mycobacteria in Cystic Fibrosis Households: A Case-control Study of Exposure Risk at Home

— Наблюдательное Cystic Fibrosis (CF) Mucoviscidosis Non-Tuberculous Mycobacteria Mycobacterium Abscessus Infection

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: Multi-modal NTM diagnostic including PCR, WGS, culture.
Кому может быть актуально
Состояния в реестре: Cystic Fibrosis (CF), Mucoviscidosis, Non-Tuberculous Mycobacteria, Mycobacterium Abscessus Infection. Базовые параметры: Без ограничений · 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
Германия
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 →

Обзор

This multicenter, non-interventional case-control study investigates whether household environmental reservoirs, particularly water systems, are associated with non-tuberculous mycobacterial (NTM) infections in people with cystic fibrosis. Environmental samples from the homes of CF patients with and without NTM infection will be analyzed and genetically compared with available clinical isolates, alongside assessment of environmental risk factors, to improve understanding of exposure pathways and inform future prevention strategies.

Подробное описание

This multicenter, non-interventional case-control study investigates whether domestic environmental reservoirs-particularly household water systems-contribute to non-tuberculous mycobacterial (NTM) infections in people with cystic fibrosis (CF). Approximately 120 CF patients from several centers in Germany will be enrolled, including 60 patients with a current or previous pulmonary NTM infection and 60 CF patients without known NTM infection as controls.

Environmental samples (water, dust, and soil) will be collected from participants' households and analyzed for the presence of NTM using culture-based methods, PCR, and whole-genome sequencing. These findings will be compared between case and control households, and genetic similarity between environmental NTM isolates and available clinical isolates from the same patients will be assessed. In addition, standardized questionnaires will capture environmental and behavioral risk factors associated with NTM occurrence.

The study is purely observational and relies on clinical data and isolates obtained through routine CF care, with no additional medical procedures for participants. Over a follow-up period of up to three years, newly occurring NTM infections in initially unaffected patients will be documented. The results aim to improve understanding of environmental exposure risks for NTM in CF and to provide evidence for future prevention strategies and potential guideline recommendations.

Вмешательства

  • Другое Multi-modal NTM diagnostic including PCR, WGS, culture
    Environmental samples from participants' households (e.g., water, dust, and soil) will be collected and tested for the presence of NTM. Analyses will be performed using PCR, culture-based methods, whole-genome sequencing (WGS), and subsequent bioinformatic analyses. In addition, available clinical NTM isolates from previous or future routine diagnostics will be included. If genomic sequencing has not yet been performed for these isolates, retrospective molecular genetic analysis (e.g., by WGS) w

Первичные конечные точки

  • Prevalence of NTM in environmental samples [Срок оценки: 2030]
  • Difference in NTM prevalence between case and control groups [Срок оценки: 2030]
  • Genetic concordance between environmental and patient isolates [Срок оценки: 2030]
Вторичные конечные точки (3)
  • Characterization of NTM species from environmental samples [Срок оценки: 2030]
  • Identification of environmental and behavioral factors associated with NTM detection [Срок оценки: 2030]
  • Long-term outcomes (control group only) [Срок оценки: 2030]

Критерии участия

Критерии включения

  • Confirmed diagnosis of cystic fibrosis (CF)
  • No age restriction (including minors with consent from legal guardians)
  • Written informed consent to participate in the study (or consent provided by a legal guardian for minors)
  • In the case of an NTM infection: diagnosis according to ATS/IDSA criteria and availability of a clinical NTM isolate

Критерии исключения

  • Lack of capacity to provide informed consent, refusal to participate, or withdrawal of informed consent

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Случай-контроль

Центры проведения

Германия · 2 центра
  • National and WHO-Supranational Reference Center for Mycobacteria, Research Center Borstel, — Borstel
  • Klinik für Pneumologie, Universitätsklinikum Essen — Essen

Идентификаторы

NCT: NCT07369414 · NTMecoCF

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗