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Systemic Traditional Chinese Medicine in Multidrug-Resistant Bacterial Pneumonia (MDRBP-TCM)

2026年7月26日 更新者：Henan University of Traditional Chinese Medicine

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

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.

研究概览

地位

尚未招聘

条件

详细说明

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.

研究类型

观察性的

注册 (估计的)

528

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

  • 姓名：Zhenzhen Feng, Doctor
  • 电话号码：+86 15890658268
  • 邮箱：huxifzz@163.com

学习地点

  • 中国
    • Henan
      • Zhengzhou、Henan、中国、450000
        • First Affiliated Hospital of Henan University of Traditional Chinese Medicine
        • 接触：
          • Zhenzhen Feng, Doctor
          • 电话号码：+86 15890658268
          • 邮箱：huxifzz@163.com

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

取样方法

非概率样本

研究人群

Hospitalized adults with clinically diagnosed pneumonia and microbiologically confirmed multidrug-resistant bacterial pathogens will be enrolled from participating centers. Eligible participants may include patients with community-acquired pneumonia, hospital-acquired pneumonia, or ventilator-associated pneumonia. Multidrug-resistant bacterial pneumonia will be defined as pneumonia in which at least one bacterial isolate demonstrates acquired non-susceptibility to at least one antimicrobial agent in each of three or more antimicrobial categories, as determined by standard antimicrobial susceptibility testing. The isolate must be considered a causative pathogen of the current pneumonia episode rather than colonization or contamination, based on clinical manifestations, imaging findings, microbiological results, and the available clinical course.

描述

Inclusion Criteria

  1. Hospitalized patients aged 18 years or older with a clinical diagnosis of pneumonia.
  2. 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.
  3. 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.
  4. Willing to participate in the study and able to provide written informed consent.

Exclusion Criteria:

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.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

队列和干预

团体/队列
Traditional Chinese Medicine Cohort
Participants who receive systemic traditional Chinese medicine treatment after enrollment during routine clinical care. Systemic traditional Chinese medicine treatment includes Chinese herbal decoctions, oral Chinese patent medicines, and Chinese medicine injections. External traditional Chinese medicine therapies will be recorded separately. The study does not assign treatment.
Non-Systemic Traditional Chinese Medicine Cohort
Participants who do not receive systemic traditional Chinese medicine treatment after enrollment during routine clinical care. Conventional diagnosis, antimicrobial therapy, supportive care, and other clinical management will be determined by treating physicians according to routine clinical practice and relevant guidelines. The study does not assign treatment.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Time to First Lower Respiratory Tract Infection Event
大体时间：From hospital discharge to 180 days after discharge
Time from hospital discharge to the first lower respiratory tract infection event. Lower respiratory tract infection events include relapse of drug-resistant bacterial pneumonia, new pneumonia, acute lower respiratory tract infection, or acute exacerbation of chronic airway disease complicated by lower respiratory tract infection. Events will be assessed based on symptoms, signs, inflammatory biomarkers, chest imaging, microbiological findings, and response to antimicrobial treatment.
From hospital discharge to 180 days after discharge

次要结果测量

结果测量
措施说明
大体时间
Mortality
大体时间：At hospital discharge (up to 90 days after enrollment), and at 30, 90, and 180 days after hospital discharge.
Number and proportion of participants who die during hospitalization or follow-up.
At hospital discharge (up to 90 days after enrollment), and at 30, 90, and 180 days after hospital discharge.
Rehospitalization
大体时间：At 30, 90, and 180 days after discharge
Number and proportion of participants who are rehospitalized after discharge.
At 30, 90, and 180 days after discharge
Upper Respiratory Tract Infection Events
大体时间：From discharge to 180 days after discharge
Number and proportion of participants with upper respiratory tract infection events, including common cold, acute viral pharyngitis, or laryngitis.
From discharge to 180 days after discharge
Bacterial Clearance
大体时间：At discharge from the initial hospitalization or completion of antimicrobial therapy (up to 90 days after enrollment).
Number and proportion of participants with confirmed or presumed clearance of the target causative pathogen. Confirmed clearance is defined as no detection of the target pathogen on follow-up microbiological testing. Presumed clearance is defined as clinical improvement without evidence of infection progression or relapse when follow-up microbiological testing is unavailable.
At discharge from the initial hospitalization or completion of antimicrobial therapy (up to 90 days after enrollment).
Clinical Cure
大体时间：At discharge from the initial hospitalization (up to 90 days after enrollment)
Number and proportion of participants with clinical cure at discharge. Clinical cure is defined as resolution or return to pre-infection status of pneumonia-related symptoms and signs, improvement or normalization of non-microbiological laboratory indicators, radiographic absorption or partial absorption, and no further need for antibacterial therapy for the index pneumonia.
At discharge from the initial hospitalization (up to 90 days after enrollment)
Antibiotic Treatment Days
大体时间：From enrollment through discontinuation of antibacterial therapy or hospital discharge, whichever occurs first (up to 90 days after enrollment).
Total number of days of antibacterial therapy from enrollment to discharge or end of treatment, including broad-spectrum or special-grade antibiotic use and combination therapy.
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
大体时间：At enrollment, discharge (up to 90 days after enrollment), and 30, 90, and 180 days after discharge
Pneumonia-related clinical status will be assessed using the Modified Community-Acquired Pneumonia Clinician-Reported Outcome Scale. The scale contains 11 clinician-reported items evaluating pneumonia-related symptoms and signs during the previous 24 hours and the clinician's overall assessment of disease improvement. Each item is scored from 0 to 4, and the item scores are summed to produce a total score ranging from 0 to 44. Higher scores indicate more severe pneumonia-related symptoms and signs and less clinical improvement.
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
大体时间：At enrollment, discharge(up to 90 days after enrollment), and 30, 90, and 180 days after discharge
Pneumonia-related symptoms and patient-perceived health status will be assessed using the Modified Community-Acquired Pneumonia Patient-Reported Outcome Scale. The scale contains 17 patient-reported items evaluating pneumonia-related symptoms during the previous 24 hours, the effects of the illness on daily activities and work or study, and satisfaction with health status and treatment effectiveness. Each item is scored from 0 to 4, and the item scores are summed to produce a total score ranging from 0 to 68. Higher scores indicate more severe pneumonia-related symptoms, greater impairment in daily functioning, and lower satisfaction with health status and treatment effectiveness.
At enrollment, discharge(up to 90 days after enrollment), and 30, 90, and 180 days after discharge
36-Item Short Form Health Survey Score
大体时间：At enrollment, discharge (up to 90 days after enrollment), and 30, 90, and 180 days after discharge
Health-related quality of life will be assessed using the 36-Item Short Form Health Survey. The instrument evaluates eight health domains. Each domain score ranges from 0 to 100, with higher scores indicating better health-related quality of life.
At enrollment, discharge (up to 90 days after enrollment), and 30, 90, and 180 days after discharge

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Henan University of Traditional Chinese Medicine

调查人员

  • 学习椅：Jiansheng Li, Doctor、The First Affiliated Hospital of Henan University of Traditional Chinese Medicine

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年8月1日

初级完成 (估计的)

2027年12月30日

研究完成 (估计的)

2028年6月30日

研究注册日期

首次提交

2026年7月7日

首先提交符合 QC 标准的

2026年7月20日

首次发布 (实际的)

2026年7月24日

研究记录更新

最后更新发布 (实际的)

2026年7月28日

上次提交的符合 QC 标准的更新

2026年7月26日

最后验证

2026年7月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • TCM for MDRBP

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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