Clinical trial NCT03934034: A Prospective Registry For Patients With Non-Tuberculous Mycobacterial (NTM) Pulmonary Disease in Korea.
Official title: A Prospective Registry For Patients With Non-Tuberculous Mycobacterial (NTM) Pulmonary Disease in Korea.
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Pulmonary Disease
Pulmonary Infection
Non-Tuberculous Mycobacterial Pneumonia
Keywords: NTM
Registry
Pulmonary infection
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Asan Medical Center
name: Samsung Medical Center
name: Pusan National University Hospital
name: Severance Hospital
name: Pusan National University Yangsan Hospital
name: Chonnam National University Hospital
name: Korean Institute of Tuberculosis
name: International Tuberculosis Research Center
First posted: 2019-05-01
Enrollment: 1000
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with NTM lung disease initiating treatment at each hospital participating in the study

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Treatment success rate
timeFrame: Through study completion, at 1 year after treatment start at enrollment
Secondary outcomes:
measure: Comparison of the efficacy among different regimens for the treatment of certain species of NTM
timeFrame: Through study completion, at 1 year after treatment start at enrollment
measure: Number of participants with changing culture results during treatment
timeFrame: Through study completion, at 1 year after treatment start at enrollment
measure: Number of participants with treatment-related adverse events
timeFrame: Through study completion, at 1 year after treatment start at enrollment
Other outcomes:
Locations:
Study officials:
References: