A Prospective Registry For Patients With Non-Tuberculous Mycobacterial (NTM) Pulmonary Disease in Korea.
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age20+
SponsorSeoul National University Hospital
About this trial
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
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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.
Trial population
Patients with NTM lung disease initiating treatment at each hospital participating in the study
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Treatment success rate
Analysis of treatment success rate according to species of NTM lung disease patients in Korea
Time frame
Through study completion, at 1 year after treatment start at enrollmentSecondary outcomes
1
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
Time frame
Through study completion, at 1 year after treatment start at enrollment2
Number of participants with changing culture results during treatment
Number of participants with changing culture results during treatment
Time frame
Through study completion, at 1 year after treatment start at enrollment3
Number of participants with treatment-related adverse events
Number of participants with treatment-related adverse events specifically described in the protocol
Time frame
Through study completion, at 1 year after treatment start at enrollmentLocations
Sponsors and contacts
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Seoul National University Hospital
Lead sponsor
Asan Medical Center
Collaborator
Samsung Medical Center
Collaborator
Pusan National University Hospital
Collaborator
Severance Hospital
Collaborator
Pusan National University Yangsan Hospital
Collaborator
Chonnam National University Hospital
Collaborator
Korean Institute of Tuberculosis
Collaborator
International Tuberculosis Research Center
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: