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Набор скоро начнётся NCT07726095

Systemic Traditional Chinese Medicine in Multidrug-Resistant Bacterial Pneumonia

Наблюдательное Multi Drug Resistant Infections Pneumnia

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: Multi Drug Resistant Infections, Pneumnia. 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
Китай
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

A Multicenter Prospective Observational Cohort Study of Systemic Traditional Chinese Medicine Treatment in Multidrug-Resistant Bacterial Pneumonia

Обзор

This is a multicenter prospective observational cohort study of hospitalized patients with multidrug-resistant bacterial pneumonia. The study will compare patients who receive systemic traditional Chinese medicine treatment during routine clinical care with those who do not receive systemic traditional Chinese medicine treatment. Systemic traditional Chinese medicine treatment may include Chinese herbal decoctions, oral Chinese patent medicines, or Chinese medicine injections. The primary objective is to evaluate whether systemic traditional Chinese medicine treatment is associated with a lower risk of lower respiratory tract infection events within 180 days after hospital discharge. Secondary outcomes include mortality, rehospitalization, bacterial clearance, clinical cure at hospital discharge, duration of antibacterial therapy, pneumonia-related clinician-reported and patient-reported outcome scores, health-related quality of life, inflammatory markers, imaging changes, safety outcomes, and direct medical costs.

Подробное описание

Multidrug-resistant bacterial pneumonia remains a major clinical challenge because of limited effective antimicrobial options, an increased risk of treatment failure and recurrent infection, and prolonged antimicrobial exposure. Traditional Chinese medicine (TCM) is commonly used as an adjunctive treatment in clinical practice in China; however, the association between systemic TCM treatment and the prognosis of patients with multidrug-resistant bacterial pneumonia has not been adequately evaluated in real-world settings.

This multicenter prospective observational cohort study will enroll hospitalized patients with multidrug-resistant bacterial pneumonia. The study is designed to evaluate the association between systemic TCM treatment received during routine clinical care and subsequent patient outcomes. Systemic TCM treatment is defined as physician-prescribed treatment with Chinese herbal decoctions, oral Chinese patent medicines, or Chinese medicine injections during hospitalization.

The study will not assign, mandate, or modify any clinical treatment. Decisions regarding antimicrobial therapy, supportive care, and TCM treatment will be made independently by the treating physicians according to the patient's clinical condition, routine clinical practice, and relevant clinical guidelines. Participants will be categorized according to whether they receive systemic TCM treatment during hospitalization, and outcomes will be compared between the exposed and unexposed groups.

This study is intended to generate real-world evidence regarding the potential role of systemic TCM treatment as an adjunct to routine clinical management in patients with multidrug-resistant bacterial pneumonia, particularly in relation to subsequent respiratory infection events, clinical recovery, antimicrobial exposure, and longer-term prognosis.

Первичные конечные точки

  • Time to First Lower Respiratory Tract Infection Event [Срок оценки: From hospital discharge to 180 days after discharge]
Вторичные конечные точки (9)
  • Mortality [Срок оценки: At hospital discharge (up to 90 days after enrollment), and at 30, 90, and 180 days after hospital discharge.]
  • Rehospitalization [Срок оценки: At 30, 90, and 180 days after discharge]
  • Upper Respiratory Tract Infection Events [Срок оценки: From discharge to 180 days after discharge]
  • Bacterial Clearance [Срок оценки: At discharge from the initial hospitalization or completion of antimicrobial therapy (up to 90 days after enrollment).]
  • Clinical Cure [Срок оценки: At discharge from the initial hospitalization (up to 90 days after enrollment)]
  • Antibiotic Treatment Days [Срок оценки: From enrollment through discontinuation of antibacterial therapy or hospital discharge, whichever occurs first (up to 90 days after enrollment).]
  • Modified Community-Acquired Pneumonia Clinician-Reported Outcome Score [Срок оценки: At enrollment, discharge (up to 90 days after enrollment), and 30, 90, and 180 days after discharge]
  • Modified Community-Acquired Pneumonia Patient-Reported Outcome Score [Срок оценки: At enrollment, discharge(up to 90 days after enrollment), and 30, 90, and 180 days after discharge]
  • 36-Item Short Form Health Survey Score [Срок оценки: At enrollment, discharge (up to 90 days after enrollment), and 30, 90, and 180 days after discharge]

Критерии участия

Критерии включения

  • Hospitalized patients aged 18 years or older with a clinical diagnosis of pneumonia.
  • Microbiological testing identifies at least one bacterial isolate that meets the definition of multidrug resistance, defined as acquired non-susceptibility to at least one antimicrobial agent in each of three or more antimicrobial categories, based on standard antimicrobial susceptibility testing.
  • The multidrug-resistant bacterial isolate is judged to be a causative pathogen of the current pneumonia episode rather than colonization or contamination, based on clinical manifestations, imaging findings, microbiological results, and the clinical course.
  • Willing to participate in the study and able to provide written informed consent.

Критерии исключения

1\. Patients who are unable to complete data collection due to unconsciousness, dementia, impaired consciousness, psychiatric illness, or other conditions, and for whom relevant information cannot be obtained through a legally authorized representative or family member.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Китай · 1 центр
  • First Affiliated Hospital of Henan University of Traditional Chinese Medicine — Чжэнчжоу

Идентификаторы

NCT: NCT07726095 · TCM for MDRBP

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗