Special Investigation of Clarith/Klaricid in Patients With Non-tuberculous Mycobacterial Pulmonary Infections
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mylan Inc.
- 入组人数
- 466
- 试验地点
- 59
- 主要终点
- Bacilli Negative Conversion Rate
研究概览
简要总结
To evaluate the efficacy and safety of long-term treatment with clarithromycin in patients with Non-tuberculous Mycobacterial Pulmonary Infections.
详细描述
Background: The revised 2007 American Thoracic Society/Infectious Diseases Society of America guidelines recommend a clarithromycin-based combination therapy for treatment of Mycobacterium avium complex (MAC) lung disease and stipulate approximately 1 year of continuous treatment after bacilli negative conversion. However, supporting data are insufficient.
Objectives: To obtain data on the clinical outcome of clarithromycin-based regimens by conducting a nationwide prospective study mainly of MAC lung disease.
Methods: In accordance with the guidelines, patients were enrolled in this survey according to their chest radiographic findings and microbiologic test results. They were treated with a multi-drug regimen including clarithromycin, rifampicin, and ethambutol (clarithromycin -based regimen) until bacilli negative conversion on continual treatment for 1 year. Data were collected "pre-administration," "on the bacilli negative conversion," and "at 6 months after the end of treatment."
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
- 15 Years 至 99 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Bacilli Negative Conversion Rate
时间窗: During the treatment with clarithromycin, from 40 days to 1232 days
Number of participants who tested positive for Bacilli before treatment and converted to Bacilli Negative at any point during the treatment with clarithromycin
次要结局
- Efficacy Evaluation Using the 4-rank Scale of "Effective", "Ineffective", "Deterioration", or "Impossible" by the Investigator(When treatment with clarithromycin is discontinued, from 40 days to 1232 days)
- Bacteriological Relapse Related to Duration of Clarithromycin Administration(36 months)