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.
