PK and PD Modeling of Ampicillin and Gentamicin in Peripartum Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Pharmacokinetic Profiling to Measure Maternal Metabolism of Ampicillin and/or Gentamicin in Pregnancy
研究概览
简要总结
This study proposes to compare the metabolism of Ampicillin and Gentamicin by pregnant women to that of non-pregnant women; the placental transfer over time; and the subsequent metabolism of the transferred drug(s) in the neonate.
详细描述
Pregnant women who present to Labor and Delivery will be identified as potential participants based on Inclusion/Exclusion criteria and their need to receive Ampicillin and/or Gentamicin therapy. The additional group of 20 non-pregnant women will also be identified based on Inclusion/Exclusion criteria and their need to receive Ampicillin and/or Gentamicin therapy.
Once identified, interested candidates will be fully informed of the study procedures, have all questions answered, and informed consent obtained.
Pregnant participants will receive Ampicillin 2g IV loading dose followed by 1g IV every 4 hrs until delivery; or Ampicillin 2g IV every 6hrs along with Gentamicin 5mg/kg IV every 24 hrs. Dose times will be recorded.
Non-pregnant participants will receive similar doses of either Ampicillin and/or Gentamicin, if not the same dose(s).
Fingerstick blood collection will be drawn from both populations at the following timepoints:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Generally healthy, pregnant woman (28-42 weeks)
- •Generally healthy, non-pregnant female
- •Scheduled to receive Ampicillin and/or Gentamicin IV
- •Ages 18-55 years old
- •Relatively normal Comprehensive Metabolic Panel (if available), as evidenced by recent blood work
- •Able and willing to sign consent
排除标准
- •Women with known renal or hepatic impairment; preeclampsia; Diabetes, including Gestational; any medical condition that, in the opinion of the Investigator or research team member, could potentially interfere with the study objectives
- •Women who are participating in another study
- •Pregnant with multiples
- •BMI > 40
研究组 & 干预措施
Pregnant/Ampicillin
pregnant participants who will receive Ampicillin for conditions such as Group B Streptococcus
干预措施: Ampicillin (Drug)
Non-pregnant/Ampicillin
non-pregnant participants who will receive Ampicillin for a qualifying hospital admission
干预措施: Ampicillin (Drug)
Pregnant and Non-pregnant/Ampicillin and Gentamicin
pregnant participants who will receive Ampicillin and Gentamicin for conditions such as chorioamnionitis; non-pregnant participants who will receive Ampicillin and Gentamicin for a qualifying hospital admission
干预措施: Ampicillin and Gentamicin (Drug)
Non-Pregnant/Gentamicin
non-pregnant participants who will receive Gentamicin for a qualifying hospital admission
干预措施: Gentamicin (Drug)
结局指标
主要结局
Pharmacokinetic Profiling to Measure Maternal Metabolism of Ampicillin and/or Gentamicin in Pregnancy
时间窗: predose; after the full initial dose of the antibiotic has infused, at 5min, 15min, 30min, 2-3hr, 4-6hr, immediately prior to the next dose of drug, and at DELIVERY
blood samples will be taken at the above timepoints; data analysis of all specimens will begin approx. 12-15 months from start of study
次要结局
- Profile of Neonatal Metabolism of Ampicillin and Gentamicin That Crosses the Placental Barrier(At delivery/upon cutting of umbilical cord)
- PD Modeling of Peripartum Patients Receiving Ampicillin and/or Gentamicin(predose; while dosing; post dose)
研究者
Brendan Carvalho
MBBCh, FRCA, MDCH, Associate Professor, Dept. of Anesthesia
Stanford University