临床试验/NCT00214331

NCT00214331已完成不适用

Pharmacokinetics and Pharmacodynamics and Selected Antibiotics During Pregnancy

University of Wisconsin, Madison1 个研究点分布在 1 个国家目标入组 150 人开始时间: 2003年4月最近更新: 2016年10月27日

适应症

干预措施

试验速览

阶段: 不适用
状态: 已完成
发起方: University of Wisconsin, Madison
入组人数: 150
试验地点: 1

研究概览研究设计入排标准研究组 & 干预措施研究者研究点记录与标识符相似试验

研究概览

简要总结

This protocol is a prospective, open-label, multicenter, population pharmacokinetic and pharmacodynamic study of selected anti-infective agents in pregnant women being treated for suspected or documented infections.

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 45 Years（Adult）
性别: Female
接受健康志愿者: 是

入选标准

•Women in their second or third trimester of pregnancy
•Women currently receiving treatment or whose physician has made the decision to start treatment with ciprofloxacin, azithromycin or gentamicin for a suspected or documented infection
•Of childbearing potential and who either have never been pregnant or whose most recent pregnancy ended 3 months previously (control group)
•Women greater than 3 months postpartum and currently breast-feeding (substudy)

排除标准

•Women with significant gastrointestinal disease which may be expected to interfere with the absorption of the orally administered anti-infective agents

研究组 & 干预措施

1

ciprofloxacin

干预措施: ciprofloxacin (Drug)

2

azithromycin

干预措施: azithromycin (Drug)

3

gentamicin

干预措施: gentamicin (Drug)

研究者

发起方

University of Wisconsin, Madison

申办方类型

Other

责任方

Sponsor

研究点 (1)

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