A drug releasing urinary catheter

描述(由申请人提供)：导尿管相关性尿路感染(UTIC)是医院和疗养院最常见的医院感染。该二期计划的目标是继续开发和评估一种新型的药物释放导尿管，该导尿管由含有防腐剂葡萄糖酸氯己定(CHG)的硅橡胶制成。CHG被限制在均匀分散在弹性体中的聚乙二醇基体内，并在长达4周的时间内以持续方式释放。这种导管材料已被证明在体外对通常与尿路感染相关的微生物有效。选择CHG作为防腐剂是基于其广谱的活性、相对较低的毒性和较低的细菌耐药性发生率。在第二阶段，将改进导管的制造方法，并根据使用时间评估导管材料抑制或杀灭细菌的有效性。将进行毒性研究，以满足医疗器械材料标准国际标准化组织10993-18的要求；并将确定导管的保质期。最后，将在一个大型动物模型中进行药物释放导管和非药物释放导管的双盲随机试验，以衡量在28天内减轻或防止Utic或幽门肾炎发展的效果。

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.