Pulmonary DiseaseNTM-KOREANCT03934034
A Prospective Registry For Patients With Non-Tuberculous Mycobacterial (NTM) Pulmonary Disease in Korea.
An observational study of Pulmonary Disease and Pulmonary Infection, run by Seoul National University Hospital.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Pulmonary Disease, Pulmonary Infection, Non-Tuberculous Mycobacterial Pneumonia
- How many people
- 1,000 participants
- Where
- No sites listed yet
- Study dates
- Apr 2019to Dec 2029
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- Adult, Older adult
Study population: Patients with NTM lung disease initiating treatment at each hospital participating in the study
Who may be able to join
- 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)
Who cannot join
- 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.
About this study
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.
- Keywords
- NTM, Registry, Pulmonary infection
- Medical subject headings
- Lung Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment success rate
Analysis of treatment success rate according to species of NTM lung disease patients in Korea
Measured: Through study completion, at 1 year after treatment start at enrollment
Secondary outcomes (3)
Comparison of the efficacy among different regimens for the treatment of certain species of NTM
Comparison of the outcomes measured by culture conversion among different regimens for the treatment of certain species of NTM
Measured: Through study completion, at 1 year after treatment start at enrollment
Number of participants with changing culture results during treatment
Number of participants with changing culture results during treatment
Measured: Through study completion, at 1 year after treatment start at enrollment
Number of participants with treatment-related adverse events
Number of participants with treatment-related adverse events specifically described in the protocol
Measured: Through study completion, at 1 year after treatment start at enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2019
- Study startApr 2019 (estimated)
- Primary completionDec 2029 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Asan Medical Center, Samsung Medical Center, Pusan National University Hospital, Severance Hospital, Pusan National University Yangsan Hospital, Chonnam National University Hospital, Korean Institute of Tuberculosis, International Tuberculosis Research Center
- Responsible party
- Principal investigator, Jae-Joon Yim, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03934034
- Sponsor's protocol ID
- NTM-KOREA
- Acronym
- NTM-KOREA
- Status last verified
- Apr 2019
- First submitted
- 22 Apr 2019
- Last updated
- 1 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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/s12931-026-03579-5.
PubMed 41723437Kwak 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.
PubMed 38563246
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Registry For Patients With Non-Tuberculous Mycobacterial (NTM) Pulmonary Disease in Korea.
- ClinicalTrials.gov ID
- NCT03934034
- Acronym / sponsor ID
- NTM-KOREA / NTM-KOREA
- Keywords
- NTM, Registry, Pulmonary infection
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Asan Medical Center, Samsung Medical Center, Pusan National University Hospital, Severance Hospital, Pusan National University Yangsan Hospital, Chonnam National University Hospital, Korean Institute of Tuberculosis, International Tuberculosis Research Center
- Study start
- Apr 2019 (estimated)
- Primary completion
- Dec 2029 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 1 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with NTM lung disease initiating treatment at each hospital participating in the study
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Treatment success rate
Time frame: Through study completion, at 1 year after treatment start at enrollment
Analysis of treatment success rate according to species of NTM lung disease patients in Korea
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2019.
- Derived from this study: PubMed 41723437Yang 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/s12931-026-03579-5.
- Derived from this study: PubMed 38563246Kwak 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Disease and Pulmonary Infection, run by Seoul National University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 1 May 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment success rate (time frame: Through study completion, at 1 year after treatment start at enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03934034, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2019.