STANDARD VERSUS BIOFILM SUSCEPTIBILITY TESTING IN CYSTIC FIBROSIS

这个子项目是许多利用 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。 这是一项随机多中心临床试验，将比较使用标准与生物膜铜绿假单胞菌痰液分离株敏感性试验的微生物学疗效、临床有效性和安全性，以指导临床稳定CF患者气道感染治疗的选择。 将对患者进行筛选，以确定合格性并进行痰培养。 符合条件的患者将被随机分配到标准或生物膜研究组。抗生素选择将根据标准算法使用指定研究组的药敏试验结果集中进行。第0天，患者将开始接受14天疗程的两种抗生素治疗，根据方案选择。 抗生素将静脉（IV）和/或口服给药。 第7天将进行电话随访或访视。 抗生素治疗完成后将进行治疗结束访视。

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. This is a randomized multi-center clinical trial that will compare the microbiological efficacy, clinical effecacy, and safety of using standard versus biofilm susceptibility testing of P. aeruginosa sputum isolates to guide selection form treatment of airway infection in clinically stable patients with CF. Patients will be screened to determine eligibility and to obtain a sputum culture. Eligible patients will be randomized to either the standard or biofilm study arm. Antibiotic selection will be performed centrally according to a standard algorithm using the susceptibility test results of the assigned study arm. On Day 0, patients will be started on a 14-day course of two antibiotics as selected per protocol. Antibiotics will be administered intravenoudly (IV) and / or orally. A follow-up phone call or visit will occur on Day 7. An end of treatment visit will be conducted after completion of antibiotic therapy.