Safety and Pharmacokinetics of Single and Multiple Dose Rifampin in Infants
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Area under the plasma concentration versus time curve 0-24 hours for rifampin
研究概览
简要总结
The purpose of this study is to learn more about the safety and dosing of rifampin in infants.
详细描述
Pharmacokinetics and safety of rifampin will be studied in term and preterm infants who are receiving rifampin per standard of care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- — 至 121 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •History of allergic reactions to rifampin
- •Aspartate aminotransferase (AST) greater than 3 times upper limit of normal
- •Alanine aminotransferase (ALT) greater than 3 times upper limit of normal
- •Serum creatinine greater than 1.7 mg.dL
- •Urine output < 0.5 mL/hr/kg over the prior 24 hours
- •Any condition which would make the subject, in the opinion of the investigator, unsuitable for the study
研究组 & 干预措施
rifampin
Cohort 1 will include infants who will be receiving up to 4 doses rifampin per study protocol.
干预措施: rifampin (Drug)
结局指标
主要结局
Area under the plasma concentration versus time curve 0-24 hours for rifampin
时间窗: Sampling for 24 hr dosing:Dose 1:0-15min,30-60min,1-3hr,3-6hr, 6-12hr,12-18hr. Dose 2,3 or 4:<15min prior to dose, 48-72hrs. Sampling for 12 hr dosing:Dose 1: 0-15min, 0.5-1hr, 1-2hr, 2-4hr, 5-8hr, 8-10 hr. Dose 2, 3 or 4:<15min prior to dose, 24-36hr
Peak plasma concentration of rifampin
时间窗: Sampling for 24 hr dosing:Dose 1:0-15min,30-60min,1-3hr,3-6hr, 6-12hr,12-18hr. Dose 2,3 or 4:<15min prior to dose, 48-72hrs. Sampling for 12 hr dosing:Dose 1: 0-15min, 0.5-1hr, 1-2hr, 2-4hr, 5-8hr, 8-10 hr. Dose 2, 3 or 4:<15min prior to dose, 24-36hr
Clearance of rifampin
时间窗: Sampling for 24 hr dosing:Dose 1:0-15min,30-60min,1-3hr,3-6hr, 6-12hr,12-18hr. Dose 2,3 or 4:<15min prior to dose, 48-72hrs. Sampling for 12 hr dosing:Dose 1: 0-15min, 0.5-1hr, 1-2hr, 2-4hr, 5-8hr, 8-10 hr. Dose 2, 3 or 4:<15min prior to dose, 24-36hr
Volume of distribution at steady state
时间窗: Sampling for 24 hr dosing:Dose 1:0-15min,30-60min,1-3hr,3-6hr, 6-12hr,12-18hr. Dose 2,3 or 4:<15min prior to dose, 48-72hrs. Sampling for 12 hr dosing:Dose 1: 0-15min, 0.5-1hr, 1-2hr, 2-4hr, 5-8hr, 8-10 hr. Dose 2, 3 or 4:<15min prior to dose, 24-36hr
Half life of rifampin
时间窗: Sampling for 24 hr dosing:Dose 1:0-15min,30-60min,1-3hr,3-6hr, 6-12hr,12-18hr. Dose 2,3 or 4:<15min prior to dose, 48-72hrs. Sampling for 12 hr dosing:Dose 1: 0-15min, 0.5-1hr, 1-2hr, 2-4hr, 5-8hr, 8-10 hr. Dose 2, 3 or 4:<15min prior to dose, 24-36hr
次要结局
- Number of subjects with adverse events as a measure of safety and tolerability.(From the time of the first dose to 3 days after the last dose; serious adverse events will be collected from the first dose of rifampin to 7 days after the last dose of rifampin.)