Chronic structural lung disease?
Conditions
Interventions
Sponsors
Eligibility
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
| Measure | Time frame |
|---|---|
| Bacterial Negativity rate?; | — |
Secondary
| Measure | Time 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
Guangdong Provincial Hospital of Chinese Medicine