Colistin in Neonatal ICU Patients With Gram Negative Resistant Infection: Dosage Personalization Approach
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Clinical response
研究概览
简要总结
A few studies have evaluated higher doses or the administration or a loading dose, which is routine in adults, in pediatric patients, and reported improved colistin exposure without an increased risk of nephrotoxicity The main questions it aims to answer are What is the optimal dosing strategies of intravenous colistin for the treatment of multidrug-resistant gram-negative bacterial infections in preterm neonates? What is the incidence of AKI? What is the factors increasing AKI incidence? A single center retrospective and comparative study, cohort study compare low dose 5 mg/kg/day versus 7.5mg/kg/day
详细描述
Retrospective study to measure safety and efficacy of colistin conventional dose versus high dose then prospective design to measure pharmacokinetics parameter of both doses to design optimal dose
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 0 Days 至 28 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Neonates aged between (0-30 days) born before 37 weeks
- •Critically ill patients with nosocomial infection with proven culture-resistant gram-negative bacteria.
- •Neonates who are indicated for colistin and started colistin therapy for at least 48 hr.
排除标准
- •Serum creatinine ≥1.5 baseline before colistin
- •Received colistin before NICU stay
- •Administration of concurrent nephrotoxic drugs including amphotericin, gentamicin, or amikacin.
- •Major congenital anomalies or with previous renal impairment.
研究组 & 干预措施
Conventional initial dose
Colistin 5mg/kg/day
干预措施: Polymyxin e (Drug)
High initial dose
Colistin 7.5mg/kg/day
干预措施: Polymyxin e (Drug)
结局指标
主要结局
Clinical response
时间窗: 21 days
Resolving signs and symptoms with normalized acute phase reactants in clinical septic patients
次要结局
- Microbiological clearance(21 days)
研究者
Mahmoud I Mostafa
Lecturer at pharmacy practice department
Helwan University