A Trial for the Safety and Effectiveness of a Novel Antimicrobial-Coated Foley Catheter for Reduction of CAUTI.

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.

Inclusion Criteria:

1. Subject is at least 18 years of age
2. Subject is expected to be catheterized with 14 or 16 French Foley catheters for at least 72 hours.
3. Subject (or a legally authorized representative) has provided written informed consent for study participation and procedures to be performed.
4. Life expectancy at least 3 months or more in the judgment of the investigator

Exclusion Criteria:

1. Subjects who present with previously known, symptomatic UTI
2. Subjects with a positive urine dipstick at the time of enrollment
3. Subjects who are on systemic antibiotics within 48 hours prior to enrollment
4. Subjects with a known of suspected allergy to silicone, silver or silver compounds causing delayed hypersensitivity reactions or contact dermatitis.
5. Subjects who have had an indwelling catheter removed less than 48 hours before study enrollment.
6. Current genitourinary tract surgery or known infection
7. Subject requires use of a non-study urinary catheter
8. Subjects known to be pregnant or breast feeding at the time of enrollment