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

Pulmonary Disease Clinical Trial

— NTM-KOREA  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03934034
• Other study ID #: NTM-KOREA
• Status: Not yet recruiting
• Start date: April 2019
• Est. completion date: December 2029

Study information

• Verified date: April 2019
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1000
• Est. completion date: December 2029
• Est. primary completion date: December 2029
• Gender: All
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lung Diseases
• Non-Tuberculous Mycobacterial Pneumonia
• Pneumonia
• Pulmonary Disease
• Pulmonary Infection

Locations

Country	Name	City	State
n/a

Sponsors (9)

Lead Sponsor	Collaborator
Seoul National University Hospital	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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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