Systemic Traditional Chinese Medicine in Multidrug-Resistant Bacterial Pneumonia (MDRBP-TCM)
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.
調査の概要
詳細な説明
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.
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前：Zhenzhen Feng, Doctor
- 電話番号：+86 15890658268
- メール：huxifzz@163.com
研究場所
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Henan
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Zhengzhou、Henan、中国、450000
- First Affiliated Hospital of Henan University of Traditional Chinese Medicine
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コンタクト：
- Zhenzhen Feng, Doctor
- 電話番号：+86 15890658268
- メール：huxifzz@163.com
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-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
サンプリング方法
調査対象母集団
説明
Inclusion Criteria
- 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.
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
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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.
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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.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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Time to First Lower Respiratory Tract Infection Event
時間枠：From hospital discharge to 180 days after discharge
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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.
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From hospital discharge to 180 days after discharge
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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Mortality
時間枠：At hospital discharge (up to 90 days after enrollment), and at 30, 90, and 180 days after hospital discharge.
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Number and proportion of participants who die during hospitalization or follow-up.
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At hospital discharge (up to 90 days after enrollment), and at 30, 90, and 180 days after hospital discharge.
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Rehospitalization
時間枠：At 30, 90, and 180 days after discharge
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Number and proportion of participants who are rehospitalized after discharge.
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At 30, 90, and 180 days after discharge
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Upper Respiratory Tract Infection Events
時間枠：From discharge to 180 days after discharge
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Number and proportion of participants with upper respiratory tract infection events, including common cold, acute viral pharyngitis, or laryngitis.
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From discharge to 180 days after discharge
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Bacterial Clearance
時間枠：At discharge from the initial hospitalization or completion of antimicrobial therapy (up to 90 days after enrollment).
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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.
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At discharge from the initial hospitalization or completion of antimicrobial therapy (up to 90 days after enrollment).
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Clinical Cure
時間枠：At discharge from the initial hospitalization (up to 90 days after enrollment)
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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.
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At discharge from the initial hospitalization (up to 90 days after enrollment)
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Antibiotic Treatment Days
時間枠：From enrollment through discontinuation of antibacterial therapy or hospital discharge, whichever occurs first (up to 90 days after enrollment).
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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.
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From enrollment through discontinuation of antibacterial therapy or hospital discharge, whichever occurs first (up to 90 days after enrollment).
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Modified Community-Acquired Pneumonia Clinician-Reported Outcome Score
時間枠：At enrollment, discharge (up to 90 days after enrollment), and 30, 90, and 180 days after discharge
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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.
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At enrollment, discharge (up to 90 days after enrollment), and 30, 90, and 180 days after discharge
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Modified Community-Acquired Pneumonia Patient-Reported Outcome Score
時間枠：At enrollment, discharge(up to 90 days after enrollment), and 30, 90, and 180 days after discharge
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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.
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At enrollment, discharge(up to 90 days after enrollment), and 30, 90, and 180 days after discharge
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36-Item Short Form Health Survey Score
時間枠：At enrollment, discharge (up to 90 days after enrollment), and 30, 90, and 180 days after discharge
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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.
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At enrollment, discharge (up to 90 days after enrollment), and 30, 90, and 180 days after discharge
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協力者と研究者
捜査官
- スタディチェア：Jiansheng Li, Doctor、The First Affiliated Hospital of Henan University of Traditional Chinese Medicine
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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