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

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Key information

Conditions

Pulmonary Disease Lung Diseases Non-Tuberculous Mycobacterial Pneumonia Pulmonary Infection Respiratory Tract Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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)

Exclusion criteria

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.

Treatment and study plan

Primary outcomes

Treatment success rate

Time frame: 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 outcomes

Comparison of the efficacy among different regimens for the treatment of certain species of NTM

Time frame: 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

Time frame: 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

Time frame: Through study completion, at 1 year after treatment start at enrollment

Number of participants with treatment-related adverse events specifically described in the protocol

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Collaborators

Asan Medical Center
Chonnam National University Hospital
International Tuberculosis Research Center
Korean Institute of Tuberculosis
Pusan National University Hospital
Pusan National University Yangsan Hospital
Samsung Medical Center
Severance Hospital

Registry information

Acronym: NTM-KOREA

Important dates

Study start: 2019
Primary completion: 2029
Study completion: 2029
First posted: May 1, 2019
Registry last updated: May 1, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed