About this trial
Nontuberculous Mycobacterial lung disease (NTM-LD) is a significant infectious challenge. The precise causes remain unclear, diagnosis can be complex, treatment outcomes are often unsatisfactory, and the disease can severely affect a patient's quality of life. Environmental factors, such as the warm and humid climate in South China, may contribute to unique characteristics of NTM in this region, but systematic research is currently lacking.
This study aims to improve the understanding of NTM-LD in South China. It consists of two complementary parts:
1. The first part is a retrospective review of medical records from approximately 1,500 NTM patients across multiple hospitals in South China. This analysis seeks to identify common patterns in symptoms, diagnostic findings, and treatment responses within this population. 2. The second part is a prospective study involving about 106 current NTM-LD patients. Blood and lung fluid samples will be collected to analyze, using advanced laboratory techniques, how the patient's immune system responds to the infection. This investigation aims to uncover clues about why some cases are difficult to treat.
The overall goal of this research is to generate evidence that can aid healthcare providers in South China in diagnosing and managing NTM-LD more effectively. Please note that this is an observational study; no new drugs or experimental treatments are being tested.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients diagnosed with nontuberculous mycobacterial according to standard guidelines.
Aged 18 years or older.
Available medical records covering the period from 2015 to 2025 (for the retrospective cohort).
Willing and able to provide written informed consent for biospecimen collection.
Disqualifiers
Active tuberculosis or other dominant pulmonary infections.
Incomplete medical records that preclude adequate data extraction (for retrospective analysis).
Contraindications to bronchoscopy or BAL procedure.
Pregnancy or lactation.
Trial population
This study population comprises patients diagnosed with nontuberculous mycobacterial infection in South China. It includes two nested cohorts: (1) a large multicenter retrospective cohort of approximately 1,500 patients identified from hospital records between 2015 and 2025, from whom clinical and epidemiological data will be extracted; and (2) a prospective sub-cohort of about 106 patients consecutively enrolled from the aforementioned group, who will provide additional biospecimens (peripheral blood and bronchoalveolar lavage fluid) for mechanistic laboratory investigations.
Trial design
Cohort
Prospective
Treatments tested in this trial
Prospective Biospecimen Sub-cohort
Other interventionObservational
Treatment groups
Trial outcomes
Primary outcomes
Clinical Phenotype Distribution
Proportion of patients with different clinical-radiological phenotypes of NTM-LD (nodular-bronchiectatic, fibrocavitary, hypersensitivity-like, and mixed patterns) based on chest CT imaging and clinical presentation.
Treatment Response Categories
Distribution of treatment outcomes including: (1) microbiological conversion (negative cultures for ≥12 months), (2) treatment failure (persistent positive cultures despite appropriate therapy), (3) treatment intolerance requiring discontinuation, and (4) spontaneous improvement without treatment.
Secondary outcomes
Spectrum of NTM Species
The spectrum and relative frequency of nontuberculous mycobacteria (NTM) species isolated from respiratory specimens (including sputum and bronchoalveolar lavage fluid) will be determined through retrospective analysis of positive culture and species identification results from the hospital's microbiology laboratory database. All patients with confirmed NTM pulmonary disease will be included in this analysis.
Clinical Prognostic Factors
Specific clinical variables assessed for their association with treatment outcome. These include: presence of cavitation on baseline chest CT, body mass index (BMI) \< 18.5 kg/m² at diagnosis, CCI, NLR, NMLR, and a history of previous NTM treatment failure.
Immunological Prognostic Factors
Specific immunological variables assessed for their association with treatment outcome. This primarily refers to the presence and titer of neutralizing anti-interferon-gamma autoantibodies (nIFN-γ-autoAbs) in serum.
Locations
Sponsors and contacts
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