Randomized, Controlled Clinical Study of Non-tuberculosis Mycobacteria Lung Disease Treatment Based on GenSeizer Characteristic Gene Capture Strategy
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 246
- 试验地点
- 1
- 主要终点
- Culture conversion rate
研究概览
简要总结
Treatment of non - tuberculosis mycobacteria lung disease is challenging. The current treatment used is from 2007 American Thoracic Society guidelines recommended antibiotic combination therapy, which is lack of validation of clinical studies. More and more studies have confirmed that NTM antibiotic resistant gene will affect the efficacy, such as erm(41), rrl to clarithromycin, rrs to amikacin and so on. This study aimed to compare the efficacy of guideline recommended therapy and optimized therapy according to antibiotic susceptibility - related genotype.Genetic testing is accomplished through GenSeizer's high-throughput gene capture technique.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients met diagnostic criteria of NTM lung disease by ATS/IDSA on 2007
- •non-CF Bronchiectasis
排除标准
- •Already on treatment for NTM lung disease
- •Appropriate exclusion of other lung diagnosis
- •Patients with severe organ dysfunction
结局指标
主要结局
Culture conversion rate
时间窗: up to 18 months
The proportion of final sputum conversion to culture negative
次要结局
- Initial time of sputum culture conversion(up to 18 months)
- Blood routine test(every month, up to 18months)
- liver function test(every month, up to 18months)
- kidney function test(every month, up to 18months)
- Chest CT(up to 18 months)
研究者
Haiqng Chu
Director
Shanghai Pulmonary Hospital, Shanghai, China