Effect of Different Colistin Doses on Clinical Outcome of Pediatric Cancer Patients With Gram Negative Infections
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- clinical improvement,
研究概览
简要总结
Prospective randomized study comparing different colistin dosing regimens in paediatric cancer patient with MDR gram-negative infection or sepsis
详细描述
The aim of this study is to:
- Evaluate the clinical outcome of two different dosing regimen of IV colistin in the treatment of children with multidrug resistant gram-negative infections or sepsis.
- To estimate the frequency of colistin associated adverse effects.
- To correlate the serum colistin concentration and MIC to microbiological clearance and clinical outcome
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
- 1 Year 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between one year and 18 years
- •All paediatric cancer patients who are prescribed intravenous colistin due to:
- •Sepsis due to MDR or minimally susceptible gram-negative bacteria
- •History of MDR gram-negative infection or sepsis due to organisms sensitive to colistin.
- •Culture result consistent with MDR gram negative for this febrile neutropenic episode.
- •Patient in sepsis and colistin was administered empirically to increase antibiotic coverage.
排除标准
- •Age less than one year or over 18 years
- •Patients with renal impairment
- •Colistin use less than 72 hours
研究组 & 干预措施
Group A Regimen
Randomized 30 pediatric subjects suffering from febrile neutropenia with proven or suspected gram negative infection will receive 2.5 mg/kg of colistimethate sodium intravenous as loading dose followed by 1.25 mg/kg every 12 hours as maintenance dose
干预措施: Colistimethate Sodium (Drug)
Group B Regimen
Randomized 30 pediatric subjects suffering from febrile neutropenia with proven or suspected gram negative infection will receive 5 mg/kg of colistimethate sodium intravenous as loading dose followed by 2.5 mg/kg every 12 hours as maintenance dose
干预措施: Colistimethate Sodium (Drug)
结局指标
主要结局
clinical improvement,
时间窗: 7- 14 days
time to defervescence
次要结局
- adverse events(14 days)
- microbiological clearance(7-14 days)