STANDARD VERSUS BIOFILM SUSCEPTIBILITY TESTING IN CYSTIC FIBROSIS

囊性纤维化的标准与生物膜敏感性测试

• 批准号: 7603356
• 负责人: DANIEL B ROSENBLUTH
• 金额: $ 0.14万
• 依托单位: WASHINGTON UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-04-01 至 2007-09-16
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7603356
• 关键词: Algorithms; Antibiotic Therapy; Antibiotics; Computer Retrieval of Information on Scientific Projects Database; Cystic Fibrosis; Eligibility Determination; Funding; Grant; Infection; Institution; Microbial Biofilms; Multi-Institutional Clinical Trial; Patients; Predisposition; Protocols documentation; Pseudomonas aeruginosa; Randomized; Research; Research Personnel; Resources; Safety; Source; Sputum; Standards of Weights and Measures; Telephone; Test Result; Testing; United States National Institutes of Health; Upper arm; Visit; clinical efficacy; cystic fibrosis patients; day; follow-up

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.

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。 这是一项随机多中心临床试验，将比较使用标准铜绿假单胞菌和生物被膜药敏试验的微生物学疗效、临床有效性和安全性，以指导临床稳定的CF患者呼吸道感染的选择治疗。将对患者进行筛查，以确定是否符合条件，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臂的药敏试验结果集中进行。在第0天，患者将按照方案选择的两种抗生素开始为期14天的疗程。抗生素将被静脉注射(IV)和/或口服。第7天将进行后续电话或访问。在抗生素治疗结束后，将进行治疗访问结束。