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

NCT03934034 | Not Yet Recruiting

• 1 other identifier: NTM-KOREA
• Study Type: observational
• Target: 1,000
• Locations: 0 countries
• Sites: N/A

Brief 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 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.

Conditions

Pulmonary Disease; Pulmonary Infection; Non-Tuberculous Mycobacterial Pneumonia

Keywords

NTM; Registry; Pulmonary infection

Outcome Measures

Primary Outcomes (1)

• Treatment success rate

  Analysis of treatment success rate according to species of NTM lung disease patients in Korea

  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

  Through study completion, at 1 year after treatment start at enrollment

• Number of participants with changing culture results during treatment

  Through study completion, at 1 year after treatment start at enrollment

• Number of participants with treatment-related adverse events

  Through study completion, at 1 year after treatment start at enrollment

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with NTM lung disease initiating treatment at each hospital participating in the study

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Seoul National University Hospital: lead
• Asan Medical Center: collaborator
• Samsung Medical Center: collaborator
• Pusan National University Hospital: collaborator
• Severance Hospital: collaborator
• Pusan National University Yangsan Hospital: collaborator
• Chonnam National University Hospital: collaborator
• Korean Institute of Tuberculosis: collaborator
• International Tuberculosis Research Center: collaborator

Related Publications (1)

• 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 DERIVED

MeSH Terms

Conditions

Lung Diseases

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Pulmonary and Critical Care Medicine

Study Record Dates

• First Submitted: April 22, 2019
• First Posted: May 1, 2019
• Study Start: April 1, 2019
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): December 1, 2029
• Last Updated: May 1, 2019

Record last verified: 2019-04