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

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03934034

Acronym

NTM-KOREA

Enrollment

1000

Registered

2019-05-01

Start date

2019-04-30

Completion date

2029-12-31

Last updated

2019-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-Tuberculous Mycobacterial Pneumonia, Pulmonary Disease, Pulmonary Infection

Keywords

NTM, Registry, Pulmonary infection

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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
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

Outcome results