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

年轻囊性纤维化患者新发铜绿假单胞菌的治疗

• 批准号: 7605113
• 负责人: Frank J. Accurso
• 金额: $ 0.44万
• 依托单位: UNIVERSITY OF COLORADO DENVER
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-03-01 至 2008-02-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7605113
• 关键词: Age; Antibiotic Therapy; Breathing; Child; Cipro; Ciprofloxacin; Clinical; Clinical Trials; Computer Retrieval of Information on Scientific Projects Database; Cystic Fibrosis; Early Intervention; Enrollment; Funding; Grant; Institution; Microbiology; Oral; Placebos; Pseudomonas aeruginosa; Randomized; Range; Recording of previous events; Research; Research Personnel; Resources; Safety; Solutions; Source; Time; Tobramycin; Treatment Protocols; United States National Institutes of Health; antimicrobial; base; children with cystic fibrosis; clinical efficacy; respiratory

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.

这个子项目是许多研究子项目中的一个 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 研究中心，而研究中心不一定是研究者所在的机构。 将在全国约60个临床中心招募约300名1至12岁的CF幼儿参加为期18个月的临床试验。当Pa（铜绿假单胞菌）首次从呼吸道培养物中分离出来或Pa在至少两年的阴性呼吸道培养史（1次培养/年）后恢复时，儿童将有资格参加研究。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）周期性抗生素治疗，即无论微生物学结果如何，每季度提供一次治疗。本研究将进一步将受试者随机分配至妥布霉素吸入溶液（TSI）和口服环丙沙星（Cipro？）或TSI和口服安慰剂治疗组。这项试验的结果将提供有关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。