THE EPIC OBSERVATIONAL STUDY

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 铜绿假单胞菌是慢性阻塞性肺疾病最重要的致病菌。慢性铜绿假单胞菌感染与患者病情加重和早期死亡有关。PA获得者早期年龄的危险因素，初始PA感染对临床结果的影响，以及各种早期抗生素治疗方案的效果仍未完全清楚。将进行一项大型的、多人参与的观察性研究，主要目标有两个。首先，这项研究将通过收集早期囊性纤维化抗假单胞菌疗法(EPIC)试验参与者的登记前特征和试验后随访，并通过提供接受首次PA分离的“常规疗法”的对照小组，来联系和加强EPIC试验。其次，将研究初次感染PA的危险因素和临床影响，以及初次感染时的治疗类型和时间与预后的关系。这是一项重要的研究，因为目前还没有针对CF患者的大型多中心研究，这些研究评估了1)首次PA感染的危险因素和临床结果，以及2)早期抗PA治疗的临床和细菌结果。这些信息是确定早期PA获得的高危特征和对年轻CF患者最有利的治疗所必需的。

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. Pseudomonas aeruginosa (Pa) is the most important bacteria in CF lung disease. Chronic Pa infection is associated with worse disease and earlier death in CF patients. Risk factors for early age at Pa acquisition, the impact of initial Pa infection on clinical outcomes, and the effect of various early antibiotic treatment regimens remain incompletely understood. A large, multi- enter, observational study will be conducted with two broad goals. First, the study will link to and enhance the Early Anti-Pseudomonal Therapy In Cystic Fibrosis (EPIC) trial by collecting pre-enrollment characteristics and post-trial follow-up on EPIC trial participants, and by providing a comparator group that receives "usual therapy" for first Pa isolation. Second, the risk factors for and clinical impact of initial Pa infection will be examined, and the association of type and length of treatment at initial infection with outcomes. This is an important study as there are no large multi-center studies in patients with CF which have evaluated 1) risk factors for and clinical outcomes of first Pa infection, and 2) the clinical and bacterial outcomes of early anti-Pa therapy. Such information is needed to identify high-risk characteristics for early Pa acquisition and treatments most beneficial to young patients with CF.