A drug releasing urinary catheter

描述（由申请人提供）：导尿管相关性尿路感染（UTIc）是在医院和疗养院获得的最常见的院内感染。该II期项目的目标是继续开发和评估一种新的药物释放导尿管，该导尿管由硅橡胶制成，含有防腐剂葡萄糖酸氯己定（CHG）。CHG被限制在聚乙二醇基质中，均匀分散在弹性体中，并在长达4周的时间内持续释放。这种导管材料已被证明是有效的体外抗微生物通常与尿路感染有关。选择CHG作为抗菌剂是基于其广谱活性、相对较低的毒性和较低的细菌耐药发生率。在第二阶段，制造导管的方法将被改进，导管材料抑制或杀死细菌的有效性作为使用时间的函数进行评估。将进行符合医疗器械材料标准ISO 10993-18要求的毒性研究；导管的保质期将被确定。最后，将在大型动物模型中进行一项药物释放与非药物释放导管的双盲随机试验，以衡量在28天内减轻或预防utc或肾盂肾炎发展的疗效。

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.