Urinary Tract Infection Clinical Trial
Official title:
A Randomized Trial for the Safety and Effectiveness of a Novel Antimicrobial-Coated Foley Catheter Attached to an Antimicrobial Anti-Reflux Device for Reduction of Catheter-Associated Urinary Tract Infection
The primary objective of this pilot study is to demonstrate the feasibility of recruiting eligible patients for the purposes of assessing the temporal aspects and rates of Catheter Associated Urinary Tract Infection (CAUTI), based on the agreed-upon case definition so that the numbers needed for a pivotal study can be better estimated.
This pilot study will be a prospective, single site, randomized clinical investigation
comparing the safety and effectiveness of the ICET TIC antimicrobial Foley catheter, against
the infection control standard-of-care, the BARD ® LUBRI-SIL® I.C. Foley catheter.
Approximately 160 patients will be screened. The study has been designed to enroll
approximately 120 eligible subjects to obtain about 60 evaluable subjects (30 in each arm).
Subjects who meet the eligibility criteria will be enrolled into the study and randomly
assigned to the experimental or standard-of-care group in a 1:1 ratio.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention
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