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

26 de julho de 2026 atualizado por: 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.

Visão geral do estudo

Status

Ainda não está recrutando

Condições

Descrição detalhada

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.

Tipo de estudo

Observacional

Inscrição (Estimado)

528

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Nome: Zhenzhen Feng, Doctor
Número de telefone: +86 15890658268
E-mail: huxifzz@163.com

Locais de estudo

China
- Henan
  - Zhengzhou, Henan, China, 450000
    - First Affiliated Hospital of Henan University of Traditional Chinese Medicine
    - Contato:
      
      Zhenzhen Feng, Doctor
      
      Número de telefone: +86 15890658268
      
      E-mail: huxifzz@163.com

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

Adulto
Adulto mais velho

Aceita Voluntários Saudáveis

Não

Método de amostragem

Amostra Não Probabilística

População do estudo

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.

Descrição

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.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

Número de grupos/coortes

Coortes e Intervenções

Grupo / Coorte
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.

Grupo / Coorte

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.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado	Descrição da medida	Prazo
Time to First Lower Respiratory Tract Infection Event Prazo: 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

Medidas de resultados secundários

Medida de resultado	Descrição da medida	Prazo
Mortality Prazo: 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 Prazo: 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 Prazo: 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 Prazo: 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 Prazo: 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 Prazo: 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 Prazo: 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 Prazo: 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 Prazo: 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

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Henan University of Traditional Chinese Medicine

Investigadores

Cadeira de estudo: Jiansheng Li, Doctor, The First Affiliated Hospital of Henan University of Traditional Chinese Medicine

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

1 de agosto de 2026

Conclusão Primária (Estimado)

30 de dezembro de 2027

Conclusão do estudo (Estimado)

30 de junho de 2028

Datas de inscrição no estudo

Enviado pela primeira vez

7 de julho de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

20 de julho de 2026

Primeira postagem (Real)

24 de julho de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

28 de julho de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

26 de julho de 2026

Última verificação

1 de julho de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

TCM for MDRBP

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

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