CTRI/2014/03/004485已完成Unknown
A prospective observational study of real world treatment outcomes in patients receiving colistimethate sodium
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 发起方
- Cipla Ltd
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Clinical Parameters:Clinical and bacteriological
研究概览
简要总结
This clinical trial is a prospective observational study for determination of real world treatment outcomes in subjects with gram negative multidrug resistant bacterial infections receiving colistimethate sodium. 100 patients will be recruited in this study at single site in India. Patients will receive the colistimethate sodium treatment as per the discretion of treating physician.
Primary outcome measures will be Clinical and bacteriological response to the treatment. Safety parameters will be assessed as a secondary measures..
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Greater than 18 years 2.A written informed consent 3.Patients suitable for treatment with colistimethate sodium, including immuno-compromised patients.
排除标准
- •1.Patients with hypersensitivity to colistimethate sodium or any exipients of its formulation.
- •2.Patients with Myasthenia gravis.
结局指标
主要结局
Clinical Parameters:Clinical and bacteriological
时间窗: Throughout the study period
response to the treatment.
时间窗: Throughout the study period
次要结局
- Incidence and nature of adverse events
- Incidence of inpatient mortality(Throughout the study period)
- Incidence of drug related adverse events
- Clinically significant changes in the vital signs, systemic examinations, ECG, chest radiograph and laboratory values(Throughout the study period)
研究者
研究点 (1)
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