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Research on Traditional Chinese Medicine Patterns for Diagnosis and Treatment of Pathogenic Bacteria Colonization in Chronic Pulmonary Infections and Development of a Predictive Model

Research on Traditional Chinese Medicine Patterns for Diagnosis and Treatment of Pathogenic Bacteria Colonization in Chronic Pulmonary Infections and Development of a Predictive Model

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ITMCTR
Registry ID
ITMCTR2025001996
Enrollment
Unknown
Registered
2025-10-22
Start date
2025-10-20
Completion date
Unknown
Last updated
2025-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic structural lung disease?

Interventions

Exposed Group:Traditional Chinese medicine therapy

Sponsors

Guangdong Provincial Hospital of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 100 Years

Inclusion criteria

Inclusion criteria: Inclusion Criteria for Staphylococcus aureus Colonization in Chronic Structural Lung Disease: (1) Age =18 years, no gender restriction; (2) Hospitalized patients with Western medicine diagnosis of chronic structural lung disease complicated by pulmonary infection, whose condition has stabilized after treatment; (3) No diagnosis of new pulmonary infection within 72 hours before enrollment, with evidence of improvement in pre-existing pulmonary infection. (4) Detection of Staphylococcus aureus (S. aureus) in any specimen (nasopharyngeal swab/sputum/bronchial lavage fluid/bronchoalveolar lavage fluid [BALF]) within 24 hours before enrollment, confirmed as colonizing bacteria by the clinical expert panel; (5) Voluntary participation by the subject or family member in this study, with signed informed consent. Inclusion Criteria for Pseudomonas aeruginosa Colonization in Chronic Structural Lung Disease: (1) Age =18 years, no gender restriction; (2) Western medical diagnosis of chronic structural lung disease in a stable disease state. Stability defined as no occurrence of any of the following within 2 months before enrollment: 1) Emergency department visits or hospitalizations; 2) Worsening respiratory symptoms, such as significantly increased cough, increased sputum volume, altered sputum characteristics, worsening dyspnea, or hemoptysis; 3) Imaging evidence of new pulmonary infection foci, cavities, bronchiectasis, or other structural pulmonary lesions; 4) Enlargement or increase in the number of existing pulmonary lesions; 5) Clinical assessment indicating need for antibiotic therapy or intensified symptomatic treatment. (3) Detection of Pseudomonas aeruginosa (PA) in sputum/bronchial lavage fluid/bronchoalveolar lavage fluid (BALF) specimens within 2 months before enrollment, confirmed as colonizing bacteria by a clinical expert panel; (4) Voluntary participation by the subject or family members in this study, with signed informed consent. Cohort Study on Pathogen Colonization in Non-Mycobacterium Tuberculosis Pulmonary Disease Patients: Analysis of Traditional Chinese Medicine Patterns and Prognosis. Inclusion Criteria: (1) Age =18 years, no gender restriction; (2) Western medical diagnosis of NTM pulmonary disease with stable disease status. Stable status defined as no occurrence of any of the following within 2 months before enrollment: 1) Emergency department visits or hospitalizations; 2) Worsening respiratory symptoms, such as significantly increased cough, increased sputum volume, altered sputum characteristics, worsening dyspnea, or hemoptysis; 3) Imaging evidence of new pulmonary infection foci, cavities, bronchiectasis, or other structural pulmonary lesions; 4) Enlargement or increase in the number of existing pulmonary lesions; 5) Clinical assessment indicating the need for antibiotic therapy or intensified symptomatic treatment. (3) Detection of Mycobacterium avium complex/Mycobacterium tuberculosis or Mycobacterium abscessus in sputum/bronchial lavage fluid/bronchoalveolar lavage fluid (BALF) specimens within 2 months before enrollment, confirmed as colonizing bacteria by a clinical expert panel; (4) Voluntary participation by the subject or family member in this study, with signed informed consent. Multi-omics Study on Respiratory Microbiota-Host Immune Interactions Driving Acute Exacerbations of Chronic Lung Infection and Secondary Lung Injury Inclusion Criteria for Healthy Individuals: (1) Age =18 years, with age and gend

Exclusion criteria

Exclusion criteria: Exclusion Criteria for Staphylococcus aureus Colonization in Chronic Structural Lung Disease: (1) Currently in the acute active phase of confirmed or suspected invasive Staphylococcus aureus infection. (2) Received antimicrobial therapy targeting Staphylococcus aureus infection for more than 48 hours within 72 hours before enrollment, or is expected to continue systemic antimicrobial therapy for Staphylococcus aureus infection. (3) Clinical Pulmonary Infection Score (CPIS) = 6 within 24 hours before enrollment; (4) Acute Physiology and Chronic Health Evaluation II (APACHE II) score = 25 and Glasgow Coma Scale (GCS) score < 12 within 24 hours before enrollment; (5) Sequential Organ Failure Assessment (SOFA) score =9; (6) History of nasal or pulmonary surgery within 4 weeks; (7) Active epistaxis, acute upper respiratory tract infection, acute rhinosinusitis, or acute exacerbation of chronic rhinosinusitis within 1 week; (8) Concurrent active pulmonary tuberculosis or immunodeficiency syndrome; (9) Patients with severe primary diseases or malignancies in other organs (e.g., heart, brain, liver, kidney); (10) Patients with psychiatric disorders or other reasons for non-compliance. Exclusion Criteria for Pseudomonas aeruginosa Colonization in Chronic Structural Lung Disease: (1) Patients with active pulmonary tuberculosis or immunodeficiency syndrome; (2) Patients with severe primary diseases or malignancies in other organs (e.g., heart, brain, liver, kidney). (3) Patients with psychiatric disorders or those unable to cooperate for other reasons. Exclusion criteria for cohort study on pathogen colonization in non-tuberculous mycobacterial lung disease patients: Analysis of TCM syndrome patterns and prognosis: (1) Patients with concurrent active pulmonary tuberculosis or immunodeficiency syndrome; (2) Patients with severe primary diseases or malignancies in other organs (e.g., heart, brain, liver, kidney); (3) Patients with psychiatric disorders or other reasons for non-compliance. Multi-omics study on respiratory microbiota-host immune interactions driving acute exacerbations of chronic pulmonary infections and secondary lung injury: Exclusion criteria for healthy individuals: (1) History of smoking; (2) History of NTM lung disease, COPD, asthma, chronic cough, bronchiectasis, tuberculosis, or other clinically significant pulmonary conditions; (3) History of pulmonary surgery; (4) Presence of malignancy, hypertension, coronary heart disease, diabetes, dermatological disorders, collagen-connective tissue diseases, or other inflammatory conditions; (5) Pregnant or lactating women; (6) Intravenous or oral antibiotic use within the past 3 months; (7) Systemic glucocorticoid therapy within the past 3 months; (8) Blood transfusion within the past 3 months; (9) Individuals with psychiatric disorders or other conditions preventing cooperation.

Design outcomes

Primary

MeasureTime frame
Bacterial Negativity rate?;

Secondary

MeasureTime frame
Mortality rate?;Pulmonary function;Frequency and Incidence of acute exacerbations in underlying pulmonary disease;The Generalized Anxiety Disorder - 7 Item Scale;The distribution and change of TCM constitution assessment;Chinese medicine factors;Distribution and changes of TCM syndromes;TCM Syndrome Score?;Number of newly acquired respiratory infections;Rate of hospital admissions;modified Medical Research Council;Chest Imaging Features?;Time to Bacterial Decolonization?;Patient Health Questionnaire-9?;Recolonization Rate;Breathlessness, Cough, and Sputum Scale;Incidence of secondary pulmonary injury;Clinical cure rate?;St. George's Respiratory Questionnaire;

Countries

China

Contacts

Public ContactLin Lin

Guangdong Provincial Hospital of Chinese Medicine

drlinlin620@163.com13903002015

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026