Efficacy and Tolerability of Linezolid for Treatment of Nontuberculous Mycobacterial Diseases
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- cure rate
研究概览
简要总结
A prospective open study to determine the efficacy and tolerability of oral linezolid 600mg./day for the treatment of 40 patients with nontuberculous mycobacterial diseases will be conducted at Siriraj Hospital, Mahidol University, Bangkok, Thailand.
详细描述
This will be an open label clinical study of oral linezolid combination with another oral antimycobacterial drug as the maintenance treatment of nontuberculous mycobacterial diseases in adult.
The eligible patients will be treated and monitored for the efficacy and safety every 6 weeks until 6 months then every 3 months for a total duration of 18 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of non-tuberculous mycobacterial (NTM) diseases
- •Active or stable diseases receiving either parenteral or oral antimycobacterial treatment
- •Require at least more than 6 months of treatment from enrollment
排除标准
- •Stable NTM diseases with a plan to discontinue treatment within 3 months
- •History of allergy to linezolid
- •Hemoglobin < 7 g/dl) or total white blood count < 3,000 /cu.mm. or thrombocytopenia < 50,000 cells/cu.mm.
- •Concomitant uses of serotoninergic drugs (SSRIs) or Monoamine oxidase inhibitor (MAOIs) within 30 days prior to enrollment
- •Abnormal neurological findings such as numbness, abnormal vision etc.
研究组 & 干预措施
treatment
oral linezolid tablet 600 mg /day combine with either oral quinolone (ciprofloxacin or levofloxacin) or oral macrolide (azithromycin or clarithromycin)
干预措施: Oral Tablet (Drug)
结局指标
主要结局
cure rate
时间窗: 6 months
no symptom and sign of active infection without drug treatment for at least 6 months
次要结局
- rate of common adverse event (AE)(18 months)
研究者
Yupin Suputtamongkol
Professor
Mahidol University