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

Innovative Chemical and Environmental Technologies

Status: Terminated

Conditions: Urinary Tract Infection

Treatments: Device: BARD® LUBRI-SIL® IC Foley Catheter; Device: ICET™ TIC Foley Catheter

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01681511

ICET-001

R44DK055891-06 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

ICET™ TIC Foley Catheter

Experimental group

Description:

Route of Administration: Urinary Bladder Catheterization

Treatment:

Device: ICET™ TIC Foley Catheter

BARD® LUBRI-SIL® IC Foley Catheter

Active Comparator group

Description:

Route of Administration: Urinary Bladder Catheterization

Treatment:

Device: BARD® LUBRI-SIL® IC Foley Catheter