Pharmacokinetics and Safety of Piperacillin-tazobactam in Neonates
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 4
- 主要终点
- Piperacillin Pharmacokinetics (PK)
研究概览
简要总结
This is a phase I open label multi-dose study to investigate the pharmacokinetics and safety of piperacillin-tazobactam in infants < 61 days of age with suspected sepsis. There will be four cohorts of 8 infants each:
- < 32 weeks gestational age (GA) and < 14 days postnatal age (PNA)
- < 32 weeks gestational age and >=14 days postnatal age
- >=32 weeks gestational age and < 14 days postnatal age
- >=32 weeks gestational age and >=14 days postnatal age. The study requires administration of 6 doses of study drug along with other antimicrobials per standard of care followed by 1 week of safety monitoring. Four 200 µL pK samples will be obtained at steady state. The risks are reasonable vs. the benefits and have been minimized appropriately. There may be benefit to the subjects (administration of broad spectrum empirical antimicrobial therapy), and information from the study may benefit a large number of other infants in whom the drug is currently being administered despite the lack of PK data in this population.
详细描述
Procedures Prior to Receipt of First Dose of Study Drug
Parental/Guardian Permission Prior to the start of any study-related procedure, a signed and dated informed consent and HIPAA authorization must be obtained and documented in the infant's medical record. Once it has been determined that the infant meets all inclusion criteria and no exclusion criteria, the infant will be assigned a subject identification number that will be used on the subject's CRFs and will be considered enrolled.
Study Drug Administration
Assignment to Therapy Groups Infants meeting the eligibility will receive piperacillin-tazobactam. Concomitant use of an aminoglycoside is suggested. Enrollment and study drug dose will be stratified by GA and PNA. After enrollment information for the eligible infant is provided, the dosage assignment and subject number will be allocated. If an infant is assigned a study drug and a number, but does not receive study drug, the subject number will not be used again. The reason for not dosing the subject will be noted on the case report form (CRF).
Dosing:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- — 至 60 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written permission from parent or legal guardian
- •< 61 days of age
- •Likely to survive beyond the first 48 hours after enrollment
- •Sufficient intravascular access (either peripheral or central) to receive study drug.
- •AND ONE OF THE FOLLOWING
- •Suspected systemic infection
- •Receiving piperacillin-tazobactam as part of standard of care
排除标准
- •History of allergic reactions to any penicillin, cephalosporins, or beta-lactamase inhibitors
- •Urine output < 0.5 mL/hr/kg over the prior 24 hours
- •Serum creatinine > 1.2 mg/dL
- •Any condition which would make the subject or the caregiver, in the opinion of the investigator, unsuitable for the study
研究组 & 干预措施
1
Open label -- 6 interval doses
干预措施: piperacillin-tazobactam (Drug)
结局指标
主要结局
Piperacillin Pharmacokinetics (PK)
时间窗: 2-3 days after infant receives 1st drug dosing
To study how Piperacillin is metabolized in the body by measuring the drug concentration in plasma samples collected at different time points during the study
次要结局
未报告次要终点
研究者
Phillip Brian Smith
Assistant Professor of Pediatrics
Duke University