Clinical and Microbiological Efficacy and Mortality of a Loading Dose of Colistin in Critical Ill Patients
试验速览
- 阶段
- 4 期
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- percentage of patients with microbiological response
研究概览
简要总结
The study hypothesis is that the loading dose of intravenous colistin (6 million of international units) is associated with greater clinical and microbiological efficacy, and reduced mortality of critically ill patients infected by multidrug resistant Gram- negative bacilli, compared to a scheme without loading dose.
详细描述
It is a prospective, multicenter, randomized, controlled study to evaluate a scheme with and without a loading dose of 6 million international units of colistin, followed by a maintenance dose of 3 million international units every 8 hours intravenous. The study should be conducted in 3 hospitals in Chile, in critically patients presenting infection by multidrug Gram-negative bacteria and requiring be treated with colistin for at least 48 hours. The objectives of the study are: to evaluate the clinical and microbiological response, and mortality.
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
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •patient hospitalized in critical care units
- •patient infected by multi drug resistant Gram negative bacteria susceptibly only to colistin
- •source of infection: blood, respiratory, intra abdominal or urinary
排除标准
- •pregnant or breastfeeding patients
- •patient with a history of hypersensitivity to colistin
研究组 & 干预措施
loading dose of colistin
Patients will receive a loading dose of colistin (6 million international units) followed by a maintenance dose of 3 million international units of colistin every 8 hours intravenous
干预措施: colistin (Drug)
without loading dose of colistin
Patients will receive 3 million international units of colistin every 8 hours intravenous
干预措施: colistin (Drug)
结局指标
主要结局
percentage of patients with microbiological response
时间窗: up to 1 week
negative culture at the same site where the positive culture was obtained before
mortality
时间窗: during their stay in the intensive care unit
the mortality during their stay in the intensive care unit, an expected average of 4 weeks
Percentage of patients with clinical response to treatment
时间窗: up to 1 week
remission or reduction of clinical signs of infection
次要结局
未报告次要终点