Clinical Characteristics and Immune Escape Mechanism of Nontuberculous Mycobacterial Lung Disease in South China

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorEighth Affiliated Hospital, Sun Yat-sen University

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Prospective Biospecimen Sub-cohort

    Other intervention

    Observational

Treatment groups

1,500 Participants
are divided into 1 treatment group
Group A: Retrospective NTM Cohort1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
At time of diagnosis (assessed retrospectively from medical records between January 2015 and May 2025)
2

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.

Time frame
12 months post-diagnosis (assessed retrospectively from medical records between January 2015 and May 2025)

Secondary outcomes

1

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.

Time frame
Species distribution will be assessed at baseline, defined as the date of the first positive NTM culture from a respiratory specimen. Retrospective data collection will cover the period from January 2015 to May 2025.
2

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.

Time frame
Assessed at baseline (within 7 days of enrollment).
3

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.

Time frame
Serum sample collected at baseline (within 7 days of enrollment) for antibody testing.

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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