Comparison of Efficacy, Safety and Economic Outcomes Between Once-Daily Versus Twice-Daily Amikacin in Combination With Cloxacillin in Febrile Neutropenic Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 166
- 主要终点
- Afebrile within 5 days of the initial treatment regimen
研究概览
简要总结
Once-daily dose administration of aminoglycoside in adults is effective and economical. However, its value in febrile neutropenic children, especially in Thailand, is less well researched. In the area where Pseudomonas aeruginosa prevalence in febrile neutropenic children is low, the combination of cloxacillin and amikacin is an appropriate approach. This study would like to compare the efficacy and safety including cost between these two amikacin administrations (once-daily or twice-daily) in combination with cloxacillin as an empirical therapy in febrile neutropenic children.
Hypothesis: Once-daily amikacin plus cloxacillin can be used to treat febrile neutropenic children in Khon Kaen, Thailand.
详细描述
Fever: a single oral temperature of >/= 38.3 degrees C; or >/= 38.0 degrees C for >/= 1 hour.
Neutropenia: neutrophil count, < 500/cu mm or <1,000/cu mm with a predicted decrease to <500/mm3.
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 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 1 year - 14 years
- •A single oral temperature of >/= 38.3 degrees C; or >/= 38.0 degrees C for >/= 1 hour.
- •Neutropenia: neutrophil count, < 500/cu mm or <1,000/cu mm with a predicted decrease to <500/mm
- •During the course of chemotherapy
排除标准
- •History of amikacin or cloxacillin allergy
- •Creatinine clearance < 30 ml/min/m2
- •Central nervous system infection: meningitis or brain abscess
- •History of hearing abnormality
- •Severely ill: shock
- •Chronic liver diseases or SGPT > 10 times of upper normal limit
- •Received aminoglycoside within 14 days prior to enrolment
- •Received any intravenous antibiotics within 7 days
- •Cancer which is newly diagnosed or relapsed
结局指标
主要结局
Afebrile within 5 days of the initial treatment regimen
Nephrotoxicity and ototoxicity
次要结局
- Pharmacokinetic parameters of amikacin in these children
- Cost difference