TREATMENT OF NEW ONSET PSEUDOMONAS AERUGINOSA IN YOUNG PTS WITH CYSTIC FIBROSIS

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。大约300名年龄在1至12岁的CF儿童将在全国约60个临床中心入组，参加为期18个月的临床试验。当首次从呼吸道培养物中分离出Pa（铜绿假单胞菌），或者在至少两年的呼吸道阴性培养史（每年1次培养）后Pa恢复，儿童将有资格参加。这项为期18个月的临床试验将调查分配给两种不同抗菌治疗方案的儿童：(1)基于培养的治疗；(2)循环抗生素治疗，即每季度提供一次治疗，无论微生物学结果如何。该研究将进一步随机分配受试者接受吸入妥布霉素溶液（TSI）和口服环丙沙星（Cipro¿）或TSI和口服安慰剂治疗。这项试验的结果将为这两种早期干预治疗策略的微生物学和临床疗效以及安全性提供有价值的信息。

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. Approximately 300 young children with CF ranging in age from 1 to 12 years will be enrolled at approximately 60 clinical centers nationwide to participate in an 18-month clinical trial. Children will be eligible to participate when Pa (Pseudomonas aeruginosa) is isolated for the first time from respiratory cultures or if Pa is recovered after at least a two-year history of negative respiratory cultures ( 1 culture/year). The 18-month clinical trial will investigate children assigned to two different antimicrobial treatment regimens: (1) culture-based therapy, and (2) cycled antibiotic therapy, i.e. treatment provided in quarterly cycles regardless of microbiology results. The study will further randomize subjects into treatment with Tobramycin solution for inhalation (TSI) and oral ciprofloxacin (Cipro¿) or TSI and oral placebo. The results from this trial will provide valuable information regarding the microbiologic and clinical efficacy, as well as safety, of these two early intervention treatment strategies.