MULTIDOSE SAFETY AND TOLERABILITY LIPOSOMAL AMIKACIN IN CYSTIC

该子项目是利用 由NIH/NCRR资助的中心赠款提供的资源。子项目和 研究者（PI）可能从另一个NIH来源获得了主要资金， 因此可以在其他CRISP条目中表示。所列机构为 中心，不一定是研究者的机构。 这项研究正在研究Arikace对患有慢性铜绿假单胞菌肺部感染的囊性纤维化[CF]患者的影响。我们将在研究药物给药后的不同时间测量血液、尿液和痰液中的研究药物量，以了解身体如何处理药物。我们还在测试血液中的某些物质是否可以帮助我们预测患者对研究药物的反应。 Arikace是一种抗生素，尚未获得美国食品和药物管理局（FDA）的批准。先前研究的综合结果显示，CF患者的肺功能改善，痰中细菌数量减少。Arikace是药物阿米卡星的变体，阿米卡星被FDA批准用于治疗由假单胞菌和某些形式的分枝杆菌引起的感染。Arikace已经制成，使抗生素包含在一种称为脂质的脂肪物质中。在本研究中，将使用雾化器吸入Arikace。研究人员希望吸入这种药物能更有效地治疗肺部感染。

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. This research is studying the effects of Arikace, in people with cystic fibrosis [CF] who have chronic Pseudomonas aeruginosa lung infections. We will be measuring the amount of study drug in the blood, the urine, and the sputum at different times after the study drug is taken to see how the body processes the drug. We are also testing whether certain substances in the blood can help us to predict a persons response to the study drug. Arikace, an antibiotic, has not been approved by the U.S. Food and Drug Administration [FDA]. Combined results from prior studies showed improvement in lung function and a decrease in the number of bacteria in the sputum of CF patients. Arikace is a variation of the drug Amikacin, which is approved by the FDA to treat infections caused by Pseudomonas and some forms of Mycobacteria. Arikace has been made so that the antibiotic is contained inside a fatty substances called lipids. In this study, the Arikace will be inhaled using a nebulizer machine. The researchers hope that breathing in this medication will target the lung infection more effectively.