Pulmonary Tuberculosis
Conditions
Interventions
Healthy Control Group:N/A
Other Respiratory Diseases Group:N/A
Suspected Pulmonary Tuberculosis Group:N/A
Treatment-na?ve Culture-positive Pulmonary Tuberculosis Group:N/A
Culture-positive Pulmonary Tuberculosis Group:N/A
Sponsors
Shanghai Pulmonary Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1.Patients in this group were individuals with culture-positive pulmonary tuberculosis diagnosed by the Tuberculosis Department of Shanghai Pulmonary Hospital. All diagnoses met the criteria outlined in the WHO Consolidated Guidelines on Tuberculosis: Module 3: Diagnosis: Rapid diagnostics for tuberculosis detection, 2024 update [11]. The bacteriological evidence required at least one of the following: a positive culture for Mycobacterium tuberculosis from a respiratory specimen (sputum/bronchoalveolar lavage fluid, BALF) or a positive GeneXpert MTB/RIF assay result, accompanied by supportive imaging findings typical of pulmonary tuberculosis on chest CT. Inclusion Criteria: (1) Met the diagnostic criteria for active pulmonary tuberculosis specified in the WHO Consolidated Guidelines on Tuberculosis: Module 3: Diagnosis, 2024 update; (2) Had definitive bacteriological evidence, i.e., a positive culture for Mycobacterium tuberculosis from a respiratory specimen (sputum/BALF) or a positive GeneXpert MTB/RIF assay result; (3) Were treatment-naïve, having just initiated a standard anti-tuberculosis treatment regimen, with treatment duration not exceeding one month; (4) Were aged between 18 and 80 years, regardless of gender; (5) Had no comorbid active pulmonary diseases (e.g., chronic obstructive pulmonary disease, lung cancer, etc.) or severe systemic diseases (e.g., advanced liver disease, malignancy, etc.). 2.Healthy Control Group: The healthy control group consisted of adults with no history of pulmonary disease, matched in age and sex with the culture-positive pulmonary tuberculosis group. Inclusion Criteria: (1) PPD skin test induration diameter <5 mm or negative immunological test for tuberculosis infection; (2) Negative results for both Xpert MTB/RIF assay and culture from respiratory specimens (sputum/bronchoalveolar lavage fluid); (3) No typical imaging signs of active pulmonary tuberculosis on chest CT; (4) Absence of respiratory symptoms (e.g., cough, expectoration) or history of chronic pulmonary diseases. 3.Other Respiratory Diseases Group: To control for interference from non-specific pulmonary acoustic features during artificial intelligence model training and validation, while ensuring the representativeness and comparability of study subjects, community-acquired pneumonia (CAP) or hospital-acquired pneumonia (HAP) were selected as common acute airway diseases in respiratory disorders. Chronic obstructive pulmonary disease (COPD) and bronchial asthma (Asthma) are the most prevalent chronic airway diseases in respiratory system conditions [12]. Both are characterized by long-term chronic cough, expectoration, and airflow limitation, thereby effectively controlling confounding variables in the study and ensuring homogeneity in disease characteristics among included patients. This approach aligns with the standardized design requirements of a prospective cohort study. Consequently, the "Other Respiratory Diseases Group" in this study was limited to three typical disease categories: chronic obstructive pulmonary disease, bronchial asthma, and pneumonia. Inclusion Criteria: (1) COPD Patient Subgroup: Aged between 18 and 80 years, regardless of gender; Diagnosed with COPD according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2023 Report [13], meeting the following conditions: pulmonary function tests showing FEV1/FVC < 0.7 (ratio of forced expiratory volume in one second to forced vital capacity le
Exclusion criteria
Exclusion criteria: 1. Age 80 years; 2. Presence of severe speech or respiratory dysfunction (e.g., laryngeal cancer, vocal cord injury, etc.); 3.Diagnosis of severe cognitive impairment, psychiatric disorders, or any condition preventing cooperation; 4. Refusal to sign the informed consent form, withdrawal from the study midway, or inability to complete follow-up; 5.Coinfection with nontuberculous mycobacterial infection or other pulmonary infectious diseases; 6.Uncontrollable strong noise interference during acoustic data collection that compromises data validity.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Imaging findings;Acoustic data;Bacteriological tests on respiratory specimens (sputum/bronchoalveolar lavage fluid); | — |
Countries
China
Contacts
Public ContactSha Wei
Shanghai Pulmonary Hospital
Outcome results
None listed