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

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 Overview

• Status: Not yet recruiting
• Conditions: Pulmonary Disease; Pulmonary Infection; Non-Tuberculous Mycobacterial Pneumonia

• Study Type: Observational
• Enrollment (Anticipated): 1000

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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	Through study completion, at 1 year after treatment start at enrollment

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): April 1, 2019
• Primary Completion (ANTICIPATED): December 1, 2029
• Study Completion (ANTICIPATED): December 1, 2029

Study Registration Dates

• First Submitted: April 22, 2019
• First Submitted That Met QC Criteria: April 30, 2019
• First Posted (ACTUAL): May 1, 2019

Study Record Updates

• Last Update Posted (ACTUAL): May 1, 2019
• Last Update Submitted That Met QC Criteria: April 30, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: Registry; NTM; Pulmonary infection
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases
• Other Study ID Numbers: NTM-KOREA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No