A Study of the Pharmacology of Tamiflu in Pregnancy
A Study of the Pharmacology of Oseltamivir (Tamiflu-Roche) in Pregnancy
研究概览
详细说明
The emergence of the novel H1N1 influenza virus has raised concern among public health officials and the public alike. Although initial reports suggested that the risk of serious disease or death was less than initially feared, continued experience suggests that the disease will have a major impact on the public's health. To address this urgent public health challenge, the centers of the Obstetric-Fetal Pharmacology Research Units Network (OPRU) will recruit a total of 75 pregnant women (25 per trimester with singletons pregnancies) who are receiving oseltamivir for supposed influenza infection. When possible, we will recruit women with twin gestation to determine if fetal number affects the drugs pharmacokinetics. We do not anticipated a significant number of multi-fetal gestations (< 10) but even limited data might prove useful in this population given the tremendous change in renal drug clearance that is normally seen in this group of women. An additional 25 healthy non-pregnant women will be studied to define pregnancy- related changes in the PK of oseltamivir and the carboxylate.
We will study each woman once during therapy, performing steady state pharmacokinetic analyses. This study will be performed after 3 days of oral therapy to optimize the possibility that steady state concentrations have been achieved.
We will:
- collect biological fluids (plasma and urine) to further characterize the pharmacology of the drug;
- collect a check swab for DNA to allow study of the impact of single nucleotide polymorphisms on drug handing and disease expression;
- develop an assay or partner with others to develop an assay for oseltamivir and the primary metabolite, oseltamivir carboxylate;
- compare the pharmacokinetics of oseltamivir and its metabolite in each trimester of pregnancy to evaluate whether gestational age has an impact on the drug's pharmacokinetics;
- assess the impact of fetal number on the drug's pharmacokinetics;
- ask all participants about GI tolerance to the drug and any side effects they may be experiencing, especially related to mood and psychiatric well being; and
- on all pregnant subjects studied, when possible, we will obtain at delivery maternal and umbilical cord blood to evaluate placental transport especially in those who deliver proximate (within 3 days) to drug treatment.
研究类型
注册 (实际的)
联系人和位置
学习地点
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Indiana
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Indianapolis、Indiana、美国、46202
- Indiana University School of Medicine
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Pennsylvania
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Pittsburgh、Pennsylvania、美国、15213
- University of Pittsburgh
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Texas
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Galveston、Texas、美国、77555
- University of Texas Medical Branch
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Washington
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Seattle、Washington、美国、98195
- University of Washington
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- Taking or about to start oral oseltamivir for presumed influenza viral infection or for prophylaxis
- Able to give informed consent
- Pregnant female with singleton or multifetal gestation or healthy non-pregnant female (ancillary study)
Exclusion Criteria:
- Unable to take medication orally
- Renal failure - creatinine > 1.5
- Hct <28
学习计划
研究是如何设计的?
设计细节
- 观测模型:队列
队列和干预
团体/队列 |
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Tamiflu use during first trimester
This group will consist of twenty-five pregnant women who are being treated with Oseltamivir for clinical indications during the first trimester of their pregnancy.
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Tamiflu use during second trimester
This group will consist of twenty-five pregnant women who are being treated with Oseltamivir for clinical indications during the second trimester of their pregnancy.
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Tamiflu use during third trimester
This group will consist of twenty-five pregnant women who are being treated with Oseltamivir for clinical indications during the first trimester of their pregnancy.
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Tamiflu use in non-pregnant women
This group will consist of twenty-five non-pregnant healthy female volunteers who are being treated with Oseltamivir.
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研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
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Apparent oral clearance of oseltamivir in singletons
大体时间:At the time of treatment
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At the time of treatment
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次要结果测量
结果测量 |
大体时间 |
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Apparent oral clearance of oseltamivir in twins
大体时间:At the time of treatment
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At the time of treatment
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Apparent renal clearance of oseltamivir carboxylate in non-pregnant women (ancillary study)
大体时间:At the time of treatment
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At the time of treatment
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Concentration of oseltamivir carboxylate and oseltamivir at times 0 and 12h to ascertain steady state status
大体时间:At the time of treatment
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At the time of treatment
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Plasma esterase activity. (ancillary study)
大体时间:At the time of treatment
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At the time of treatment
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Maternal side effects -GI upset, pregnancy loss, neuropsychiatric disorder
大体时间:At the time of treatment
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At the time of treatment
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Maternal and cord blood oseltamivir and oseltamivir carboxylate concentrations
大体时间:At delivery
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At delivery
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合作者和调查者
调查人员
- 首席研究员:Richard Beigi, MD、University of Pittsburgh
- 首席研究员:Steve Caritis, MD、University of Pittsburgh
- 首席研究员:Raman Venkataramanan, PhD、University of Pittsburgh
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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