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Not yet recruiting NCT03934034

A Prospective Registry For Patients With Non-Tuberculous Mycobacterial (NTM) Pulmonary Disease in Korea.

— Observational Pulmonary Disease Pulmonary Infection Non-Tuberculous Mycobacterial Pneumonia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Pulmonary Disease, Pulmonary Infection, Non-Tuberculous Mycobacterial Pneumonia. Basic parameters: from 20 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

The incidence and prevalence of pulmonary disease due to Non-tuberculous mycobacteria (NTM) is increasing worldwide, and this trend has been confirmed in Korea. Treatment of NTM pulmonary disease is difficult and usually requires more than two years of long-term treatment, and the antibiotic regimens used in treatment vary. Therefore, it is difficult to track the natural history of patients with NTM pulmonary disease, to evaluate the treatment outcome, and to understand the effect of specific medicines on the outcome. Establishing a prospective registry of patients with NTM pulmonary disease is expected to accurately evaluate the progress, treatment modality, and treatment outcome of NTM pulmonary disease.

Primary outcome measures

  • Treatment success rate [Time frame: Through study completion, at 1 year after treatment start at enrollment]
Secondary outcome measures (3)
  • Comparison of the efficacy among different regimens for the treatment of certain species of NTM [Time frame: Through study completion, at 1 year after treatment start at enrollment]
  • Number of participants with changing culture results during treatment [Time frame: Through study completion, at 1 year after treatment start at enrollment]
  • Number of participants with treatment-related adverse events [Time frame: Through study completion, at 1 year after treatment start at enrollment]

Eligibility criteria

Inclusion criteria

  • Clinical diagnosis of NTM pulmonary disease.
  • The causative agent of NTM pulmonary disease includes: M. avium complex, or M. abscessus subspecies abscessus, or M. abscessus subspecies massiliense, or M. kansasii.
  • Patients who starts new treatment (those who have previous history of treatment are eligible)

Exclusion criteria

  • Patients who have been treated for more than 4 weeks.
  • The causative agent of NTM pulmonary disease is none of M. avium complex, M. abscessus subspecies abscessus, M. abscessus subspecies massiliense, or M. kansasii.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Publications

  • Yang S, Park Y, Kwak N, Hwang H, Jeon D, Jhun BW, Jo KW, Kim HJ, Kim JY, Kim YR, Kwon YS, Lee JH, Mok J, Shim TS, Sohn H, Whang J, Kim J, Park N, Lee GI, Yim JJ, Kang YA. Association between nutritional status and clinical characteristics in nontuberculous mycobacterial pulmonary disease: preliminary results from the NTM-KOREA cohort. Respir Res. 2026 Feb 21;27(1):116. doi: 10.1186/s12931-026-0357 PMID 41723437
  • Kwak N, Henkle E, Hwang H, Jeon D, Jhun BW, Jo KW, Kang YA, Kim HJ, Kim JY, Kim YR, Kwon YS, Lee JH, Mok J, Park Y, Shim TS, Sohn H, Whang J, Yim JJ. Improvement in Health-Related Quality of Life Following Antibiotic Treatment in Nontuberculous Mycobacterial Pulmonary Disease: Initial Analysis of the NTM-KOREA Cohort. Clin Infect Dis. 2024 Jun 14;78(6):1690-1697. doi: 10.1093/cid/ciae131. PMID 38563246

Identifiers

NCT: NCT03934034 · NTM-KOREA

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗