PHARMACOKINETICS AND PHARMACODYNAMICS OF SELECTED ANTIBIOTICS IN PREGNANCY

本子项目是利用由NIH/NCRR资助的中心赠款提供的资源的众多研究子项目之一。子项目和研究者（PI）可能已经从另一个NIH来源获得了主要资金，因此可以在其他CRISP条目中表示。列出的机构是中心的，不一定是研究者的机构。这项研究的目的是更多地了解怀孕期间身体是如何处理一些药物的。庆大霉素、阿奇霉素和环丙沙星是用于治疗感染的抗生素。为了更多地了解这些药物在怀孕期间是如何进入和离开身体的，美国食品和药物管理局赞助了这项研究。要符合资格，参与者必须处于妊娠中期或晚期，或者必须在三个多月前分娩。参与者还必须在医生的监督下使用这些抗生素中的一种来治疗感染。在研究期间，参与者将继续按照医生的指示服用药物。参与者将记录他们的药物，并在研究期间抽血和分析两次。参与者及其婴儿也将被监测是否有任何副作用，并从医疗记录中收集有关病史和当前健康状况的信息。对于怀孕的参与者，我们还将收集新生儿出生后的健康信息。血液将被分析，以测试在不同时间血液中的药物水平。对参与者的治疗不会有其他变化，所以所有关于如何最好地治疗感染的决定都将由参与者和她的医生做出，不应该受到研究的影响。在其他一些中心，没有怀孕或正在哺乳的人可以参加，但在密歇根大学，只有怀孕中期或晚期的妇女或三个多月前分娩的妇女才能参加。

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. The purpose of this study is to learn more about how some medications are processed by the body during pregnancy. Gentamicin, azithromycin, and ciproflaxin are antibiotics used to treat infection. To learn more about how these drugs enter and leave the body in pregnancy, the US Food and Drug Administration has sponsored this study. To be eligible, participants must be in their second or third trimester of pregnancy, or must have given birth more than three months ago. Participants must also be using one of these antibiotics under a doctor's supervision to treat an infection. During the study, participants would continue to take the medication as directed by their doctor. Participants would keep track of their medicatoins, and have their blood drawn and analyzed two times during the study. Participants and their infants will also be monitored for any side effects, and information about medical history and current health will be collected from medical records. For pregnant participants, we will also collect information on the health of the newborn baby after birth. The blood will be analyzed to test the levels of medication in the blood at different times. There will be no other change in treatment for participants, so all decisions regarding how best to treat infections will be made by the participant and her doctor and should not be affected by the study. At some other centers, people who are not pregnant, or who are lactating (producing breast milk) may participate, but at the University of Michigan, only women in their second or third trimester of pregnancy or who gave birth more than three months ago will be participating.