Safety and Pharmacokinetics of Multiple Dose Metronidazole in Premature Infants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 3
- 主要终点
- Loading Dose Maximum Concentration
研究概览
简要总结
Yearly in the United States over 500,000 newborns are delivered prematurely. This population is at high risk of catastrophic bowel disease known as necrotizing enterocolitis. Infants with necrotizing enterocolitis are at high risk of death, and survivors are at increased risk of mental retardation. Metronidazole is an antibiotic that is often administered to infants with suspected or confirmed necrotizing enterocolitis. Unfortunately, the appropriate dose of metronidazole in premature infants has not been established and it is likely to be different from older children and adults.
The investigators will investigate the appropriate metronidazole dose in very premature infants by: 1) determining how premature infants eliminate metronidazole from the body and 2) determining the safest and most effective dose of metronidazole in premature infants.
The investigators hypothesis are: 1) The rate of removal of metronidazole will increase with infant maturity and 2) an appropriate metronidazole dosing regimen will result in necessary drug levels to treat bacteria involved in necrotizing enterocolitis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 90 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Gestational age <32 weeks at the time of enrollment.
- •Postnatal age <91 days at the time of enrollment.
- •Sufficient venous access to permit administration of study medication.
- •Infant suspected to have a serious infection and from whom a blood culture has been obtained within 96 hours of study entry.
排除标准
- •History of anaphylaxis to metronidazole or other nitroimidazole derivatives (e.g., tinidazole).
- •Previous exposure to metronidazole in the week prior to study.
- •Previous participation in the study.
研究组 & 干预措施
Treatment
Intravenous metronidazole loading dose 15 mg/kg followed by 7.5 mg/kg every 12-24 hours
干预措施: Metronidazole (Drug)
结局指标
主要结局
Loading Dose Maximum Concentration
时间窗: 2-5 days of study drug administration
Loading Dose Maximum concentration (Cmax)
Area Under the Curve at Steady State
时间窗: pre-dose: 30 min; post-dose:10 min, 3-4,6-8, 12-13, 24-25, 36-37, 48-49, 72-73 hours post dose
Area under the curve at steady state (AUCss)
Multiple Dose Maximum Concentration
时间窗: 2-5 days of study drug administration
Multiple Dose Maximum Concentration (mg/L)
Volume of Distribution
时间窗: 2-5 days of study drug administration
Volume of Distribution (L/kg)
Clearance
时间窗: 2-5 days of study drug administration
Clearance (L/h/kg)
Loading Dose Minimum Concentration
时间窗: 2-5 days of study drug administration
Loading Dose Minimum Concentration (mg/L)
Multiple Dose Minimum Concentration
时间窗: 2-5 days of study drug administration
Multiple Dose Minimum Concentration (mg/L)
次要结局
未报告次要终点
研究者
Michael Cohen-Wolkowiez
Assistant Professor of Pediatrics
Duke University