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

NCT ID: NCT01681511

Last Updated: 2014-04-28

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-05-31
• Study Completion Date: 2013-01-31

Brief Summary

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.

Detailed 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.

Conditions

Urinary Tract Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

ICET™ TIC Foley Catheter

Route of Administration: Urinary Bladder Catheterization

Group Type: EXPERIMENTAL

ICET™ TIC Foley Catheter

Intervention Type: DEVICE

The device to be evaluated in this investigation is a silver-based antimicrobial coated Foley catheter connected to an antimicrobial anti-reflux accessory (ICET Inc, Norwood, MA). The closed system is referred to as the TIC system and is designed with the objective of reducing the incidence of CAUTI. The accessory is non-tissue contacting.

BARD® LUBRI-SIL® IC Foley Catheter

Route of Administration: Urinary Bladder Catheterization

Group Type: ACTIVE_COMPARATOR

BARD® LUBRI-SIL® IC Foley Catheter

Intervention Type: DEVICE

The LUBRI-SIL® I.C. antimicrobial 100% silicone Foley catheter incorporates a formulation consisting of BACTI-GUARD®\* silver alloy coating and BARD® hydrogel.

Interventions

ICET™ TIC Foley Catheter

The device to be evaluated in this investigation is a silver-based antimicrobial coated Foley catheter connected to an antimicrobial anti-reflux accessory (ICET Inc, Norwood, MA). The closed system is referred to as the TIC system and is designed with the objective of reducing the incidence of CAUTI. The accessory is non-tissue contacting.

Intervention Type: DEVICE

BARD® LUBRI-SIL® IC Foley Catheter

The LUBRI-SIL® I.C. antimicrobial 100% silicone Foley catheter incorporates a formulation consisting of BACTI-GUARD®\* silver alloy coating and BARD® hydrogel.

Intervention Type: DEVICE

Other Intervention Names

ICET™ TIC Foley Catheter Device (TIC System); BARD ® LUBRI-SIL® I.C. Foley Catheter Device

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role: collaborator

Innovative Chemical and Environmental Technologies, Inc

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Susan E Kline, MD

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Locations

University of Minnesota Fairview medical center

Minneapolis, Minnesota, United States

Countries

United States

References

Leuck AM, Johnson JR, Hunt MA, Dhody K, Kazempour K, Ferrieri P, Kline S. Safety and efficacy of a novel silver-impregnated urinary catheter system for preventing catheter-associated bacteriuria: a pilot randomized clinical trial. Am J Infect Control. 2015 Mar 1;43(3):260-5. doi: 10.1016/j.ajic.2014.11.021.

Reference Type: DERIVED

PMID: 25728152 (View on PubMed)

Other Identifiers

R44DK055891-06

Identifier Type: NIH

Identifier Source: secondary_id

View Link

ICET-001

Identifier Type: -

Identifier Source: org_study_id