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

Not yet recruiting

• Conditions: Pulmonary Infection; Non-Tuberculous Mycobacterial Pneumonia; Pulmonary Disease

• Registration Number: NCT03934034
• Lead Sponsor: Seoul National University Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2019-04
• Study Start: 2019-04
• Study First Submitted: 2019-04-22
• Study First Submitted QC: 2019-04-30
• Last Update Submitted: 2019-04-30
• Study First Posted: 2019-05-01
• Last Update Posted: 2019-05-01
• Primary Completion: 2029-12
• Study Completion: 2029-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 1000

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Treatment success rate	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

Secondary Outcome Measures

Name	Time	Method
Number of participants with changing culture results during treatment	Through study completion, at 1 year after treatment start at enrollment	Number of participants with changing culture results during treatment
Number of participants with treatment-related adverse events	Through study completion, at 1 year after treatment start at enrollment	Number of participants with treatment-related adverse events specifically described in the protocol
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	Comparison of the outcomes measured by culture conversion among different regimens for the treatment of certain species of NTM