THE EPIC OBSERVATIONAL STUDY

该子项目是利用NIH/NCRR资助的中心赠款提供的资源的许多研究子项目之一。子项目和研究者（PI）可能从另一个NIH来源获得主要资金，因此可以在其他CRISP条目中表示。所列机构为中心，不一定是研究者所在机构。铜绿假单胞菌（Pseudomonasaeruginosa，Pa）是CF肺部疾病中最重要的致病菌。慢性Pa感染与CF患者的疾病恶化和早期死亡相关。Pa感染早期的危险因素、初始Pa感染对临床结局的影响以及各种早期抗生素治疗方案的效果仍不完全清楚。将进行一项大型、多中心、观察性研究，有两个广泛的目标。首先，该研究将通过收集EPIC试验参与者的入组前特征和试验后随访，以及通过提供接受首次Pa隔离的“常规治疗”的对照组，与囊性纤维化（EPIC）试验中的早期抗假单胞菌治疗相关联并增强该试验。其次，将检查初始Pa感染的风险因素和临床影响，以及初始感染时的治疗类型和持续时间与结局的相关性。这是一项重要的研究，因为没有在CF患者中进行的大型多中心研究，这些研究评价了1）首次Pa感染的风险因素和临床结局，以及2）早期抗Pa治疗的临床和细菌结局。需要这些信息来识别早期Pa获得的高风险特征和对年轻CF患者最有益的治疗。

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.