A Study of the Pharmacology of Tamiflu in Pregnancy
A Study of the Pharmacology of Oseltamivir (Tamiflu-Roche) in Pregnancy
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
連絡先と場所
研究場所
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Indiana
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Indianapolis、Indiana、アメリカ、46202
- Indiana University School of Medicine
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Pennsylvania
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Pittsburgh、Pennsylvania、アメリカ、15213
- University of Pittsburgh
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Texas
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Galveston、Texas、アメリカ、77555
- University of Texas Medical Branch
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Washington
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Seattle、Washington、アメリカ、98195
- University of Washington
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-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
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
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 観測モデル:コホート
コホートと介入
グループ/コホート |
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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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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
時間枠 |
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Apparent oral clearance of oseltamivir in singletons
時間枠:At the time of treatment
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At the time of treatment
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二次結果の測定
結果測定 |
時間枠 |
---|---|
Apparent oral clearance of oseltamivir in twins
時間枠: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)
時間枠: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
時間枠:At the time of treatment
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At the time of treatment
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Plasma esterase activity. (ancillary study)
時間枠: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
時間枠: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
時間枠:At delivery
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At delivery
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協力者と研究者
捜査官
- 主任研究者:Richard Beigi, MD、University of Pittsburgh
- 主任研究者:Steve Caritis, MD、University of Pittsburgh
- 主任研究者:Raman Venkataramanan, PhD、University of Pittsburgh
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- OPRU Tamiflu
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