A Rational Approach to the Identification of New Treatment Options to Prevent Congenital Syphilis: Phase 1 Study of the Pharmacokinetics of Amoxicillin in Pregnancy
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Change of Amoxicillin Level in Plasma during Pregnancy
研究概览
简要总结
The study design is a prospective phase I pharmacokinetic study focused on dosing of 500 mg oral amoxicillin administration in pregnant women in the 2nd and 3rd trimester.
详细描述
Twenty adult pregnant women in good health who are admitted for preterm premature rupture of membranes (24-34 weeks gestational age) will be enrolled in this intensive pharmacokinetic study. Basic information will be collected from the medical record including age, weight, height, pregnancy dating, medications, and allergies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 50 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnant, engaged in prenatal care with a medical provider (at least one visit)
- •Estimated gestational age 24-34 weeks
- •Able to provide informed consent
- •English speaking
排除标准
- •Receipt of amoxicillin within the past 7 days. (Routine GBS prophylaxis with ampicillin or other antibiotic and routine surgical prophylaxis prior to cesarean with cephalexin and azithromycin 500 mg IV is allowed).
- •Known hypersensitivity or intolerance of amoxicillin, penicillin, other beta lactam or cephalosporin antibiotics.
- •Known renal impairment (serum creatinine ≥1.2 mg/dL).
- •Active concomitant medications known to interact with amoxicillin: allopurinol, methotrexate, mycophenolate, immune checkpoint inhibitors (ie. pembrolizumab), tetracyclines (ie. doxycycline), vitamin K antagonists (ie. warfarin), aminoglycosides (ie. gentamicin).
研究组 & 干预措施
Amox 500 mg
Amoxicillin 500 mg PO
干预措施: Amoxicillin (Drug)
结局指标
主要结局
Change of Amoxicillin Level in Plasma during Pregnancy
时间窗: 0, 1, 2, 3, 4, 6, 8 hours after medication administration
quantitative drug level in blood
Amoxicillin Level in Cord Blood
时间窗: at delivery
quantitative drug level in cord blood to calculate transplacental transfer rate for amoxicillin
Change of Amoxicillin Level in Plasma in the Postpartum state
时间窗: 0, 1, 2, 3, 4, 6, 8 hours after medication administration
quantitative drug levels in blood to compare to pregnancy state values
次要结局
- Additional pharmacologic measure(1-8 hours after administration)
- additional pharmacologic measures(1-8 hours after administration)
研究者
Jodie A. Dionne, MD
Associate Professor of Medicine; Division of Infectious Diseases
University of Alabama at Birmingham