A drug releasing urinary catheter

描述（由申请人提供）：导管相关尿路感染（UTIc）是医院和疗养院最常见的医院感染。该II期项目的目标是继续开发和评价一种由含有防腐剂葡萄糖酸氯己定（CHG）的硅橡胶制成的新型药物释放导尿管。CHG被限制在均匀分散在弹性体中的聚乙二醇基质中，并且其以持续方式释放长达4周。该导管材料已被证明在体外可有效对抗通常与UTI相关的微生物。选择CHG作为防腐剂是基于其广谱活性、相对低的毒性和细菌耐药性发生率低。在第二阶段，将改进导管的制造方法，并评估导管材料抑制或杀灭细菌的有效性随使用时间的变化。将进行符合ISO 10993-18（医疗器械材料标准）要求的毒性研究;并将确定导管的有效期。最后，将在大型动物模型中进行药物释放导管与非药物释放导管的双盲、随机试验，以测量在28天内减轻或预防UTIC或幽门肾炎发展的疗效。

DESCRIPTION (provided by applicant): Catheter-associated urinary tract infection (UTIc) is the most common nosocomial infection acquired in hospitals and nursing homes. The goal of this Phase II program is to continue the development and evaluation of a new, drug releasing urinary catheter fabricated from silicone rubber containing the antiseptic agent chlorhexidine gluconate (CHG). The CHG is confined in a polyethylene glycol matrix uniformly dispersed in the elastomer, and it is released in sustained fashion over periods up to 4 weeks. This catheter material has been shown to be effective in vitro against organisms commonly associated with UTI. The choice of CHG as the antiseptic agent is based on its broad spectrum of activity, comparatively low toxicity, and low incidence of the development of bacterial resistance. In Phase II, methods for fabricating the catheters will be refined, and the effectiveness of the catheter material to inhibit or kill bacteria as a function of usage time evaluated. Toxicity studies required to fulfill the requirements of ISO 10993-18, a standard for medical device materials, will be conducted; and the shelf life of the catheters will be determined. Finally, a double blind, randomized trial of drug releasing versus nondrug releasing catheters in a large animal model will be conducted to measure efficacy in lessening or preventing the development of UTIc or pylonephritis over a 28 day period.