DEVELOPMENT OF AN ANTIMICROBIAL URETHRAL URINARY CATHETER FOR LONG-TERM INDWELLING URETHRAL CATHETERIZATION

THIS PROJECT WILL FURTHER DEVELOP TWO METHODS FOR INCORPORATING ANTIBIOTICS INTO SURFACE COATINGS AND WILL ALSO COMPARE THE RELATIVE UTILITY OF THE TWO METHODS, DIRECTINCORPORATION OF THE ANTIBIOTIC INTO THE COATING AT MANUFACTURE VS. IMBIBITION OF THE ANTIBIOTIC INTO THE COATING JUST PRIOR TO CATHETERIZATION; THE FEASIBILITY OF INCORPORATING ACETOHYDROXAMIC ACID, AN INHIBITOR OF BACTERIAL URASE, IN THE COATINGS TO REDUCE MINERAL ENCRUSTATION WILL ALSO BE EXAMINED. ONE COATING COMPOSITIONHAS A SLOW RELEASE OF ANTIBIOTIC (A FLUOROQUNOLONE) OVER A 5-WEEK PERIOD WITH EFFECTIVE LEVELS OF ANTIBIOTIC NEAR THE DEVICE SURFACE AS DEMONSTRATED BY ZONE OF INHIBITION TESTS AGAINST TYPICAL URINARY TRACT ORGANISMS. MANAGEMENT OF URINARY TRACT INFECTIONS RESULTING FROM CATHETERIZATION IS A GROWING PROBLEM AS THE U.S. POPULATION AGES. FOCUSING THE ANTIBIOTIC ON THE URETHAL URINARY CATHETER SURFACE WILL MEAN LOW AGGREGATE DOSAGE LEVEL WHILE STILL ACHIEVING USEFUL CONCENTRATIONS ON THE DEVICE SURFACE,THUS ELIMINATING MANY OF THE SIDE EFFECTS THAT ARE TYPICAL WITH VASCULAR ADMINISTRATION OF ANTIBIOTICS. THIS PHASE I STUDY WILL PROVIDE A BASIS FOR DESIGNING THE PHASE II PROGRAM; THOSE METHODS SHOWING THE MOST PROMISE WILL BE DEVELOPED IN PHASE II.