NCT02162966Unknown4 期
Use Of High Dose Colistin in Multi Drug Resistant Gram Negative Infections in Critically Ill Adult Patients. Randomized Controlled Clinical Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 入组人数
- 330
- 试验地点
- 1
- 主要终点
- Evaluate safety of high dose Colistin
研究概览
简要总结
Colistin is a rapidly acting bactericidal antimicrobial agent that possesses a post antibiotic effect against MDRO Gram-negative bacteria, such as as Pseudomonas aeruginosa, Acinetobacterbaumannii, and Klebsiella pneumonia.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient age more than or equal 18 years old.
- •Patient has clinical signs and symptoms of infection with suspected or proven infection due to Carbapenem resistant microorganism.
- •Patient was started with Empirical therapy of Colistin and positive MDRO within 5 days of empirical therapy.
排除标准
- •Patient age less than 18 years.
- •Pregnant patient.
- •If received Colistin treatment for less than 72 hours.
- •Renal Replacement Therapy.
研究组 & 干预措施
High Dose Colistin
Experimental
High dose colistin protocol
干预措施: High Dose Colistin (Drug)
Standard Dose Colistin
Active Comparator
Standard dose of colistin
干预措施: Standard Dose Colistin (Drug)
结局指标
主要结局
Evaluate safety of high dose Colistin
时间窗: 7 to 21 days after giving Colistin
Evaluate the safety of high dose Colistin to treat MDRO infection in critically ill patients. The safety of high dose Colistin will be determined by number of participants whom renal function will be deviated from the baseline after administering high dose of Colistin.
次要结局
- Length of ICU stay(28 days after enrollment)
- Microbiological response(A day 7 and at the end of therapy)
- All cause mortality(7 days after the end of therapy or at 28 days after enrollment)
- Ventilation free days(28 days after enrollment)
研究者
研究点 (1)
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