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

NCT ID: NCT03934034

Last Updated: 2019-05-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-04-30

Study Completion Date

2029-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Pulmonary Disease Pulmonary Infection Non-Tuberculous Mycobacterial Pneumonia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Asan Medical Center

OTHER

Sponsor Role collaborator

Samsung Medical Center

OTHER

Sponsor Role collaborator

Pusan National University Hospital

OTHER

Sponsor Role collaborator

Severance Hospital

OTHER

Sponsor Role collaborator

Pusan National University Yangsan Hospital

OTHER

Sponsor Role collaborator

Chonnam National University Hospital

OTHER

Sponsor Role collaborator

Korean Institute of Tuberculosis

OTHER

Sponsor Role collaborator

International Tuberculosis Research Center

OTHER

Sponsor Role collaborator

Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jae-Joon Yim

Professor, Pulmonary and Critical Care Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

References

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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.

Reference Type DERIVED
PMID: 38563246 (View on PubMed)

Other Identifiers

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NTM-KOREA

Identifier Type: -

Identifier Source: org_study_id

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