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

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。 大约300名年龄从1岁到12岁的儿童将在全国大约60个临床中心登记参加为期18个月的临床试验。当PA(铜绿假单胞菌)首次从呼吸道培养中分离出来，或者如果PA在至少两年的呼吸道培养阴性病史(1种培养/年)后恢复，儿童将有资格参加。这项为期18个月的临床试验将调查被分配到两种不同抗菌治疗方案的儿童：(1)基于培养的治疗，和(2)循环抗生素治疗，即无论微生物学结果如何，每季度提供一次治疗。这项研究将进一步随机将受试者分为妥布霉素雾化吸入溶液(TSI)和口服环丙沙星(Ciprox)或TSI和口服安慰剂。这项试验的结果将提供关于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的有价值的信息。

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.