A Prospective Registry For Patients With Non-Tuberculous Mycobacterial (NTM) Pulmonary Disease in Korea.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 1,000
- 主要终点
- Treatment success rate
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- 未提供
结局指标
主要结局
Treatment success rate
时间窗: 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
次要结局
- Number of participants with changing culture results during treatment(Through study completion, at 1 year after treatment start at enrollment)
- Number of participants with treatment-related adverse events(Through study completion, at 1 year after treatment start at enrollment)
- 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)
研究者
Jae-Joon Yim
Professor, Pulmonary and Critical Care Medicine
Seoul National University Hospital