A Multicenter Prospective Observational Cohort Study of Systemic Traditional Chinese Medicine Treatment in Multidrug-Resistant Bacterial Pneumonia
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 528
- 试验地点
- 1
- 主要终点
- Time to First Lower Respiratory Tract Infection Event
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
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.
结局指标
主要结局
Time to First Lower Respiratory Tract Infection Event
时间窗: 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.
次要结局
- Mortality(At hospital discharge (up to 90 days after enrollment), and at 30, 90, and 180 days after hospital discharge.)
- Rehospitalization(At 30, 90, and 180 days after discharge)
- Upper Respiratory Tract Infection Events(From discharge to 180 days after discharge)
- Bacterial Clearance(At discharge from the initial hospitalization or completion of antimicrobial therapy (up to 90 days after enrollment).)
- Clinical Cure(At discharge from the initial hospitalization (up to 90 days after enrollment))
- Antibiotic Treatment Days(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(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(At enrollment, discharge(up to 90 days after enrollment), and 30, 90, and 180 days after discharge)
- 36-Item Short Form Health Survey Score(At enrollment, discharge (up to 90 days after enrollment), and 30, 90, and 180 days after discharge)