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.

Study Overview

• Status: Terminated
• Conditions: Urinary Tract Infection
• Intervention / Treatment: Device: ICET™ TIC Foley Catheter; Device: BARD® LUBRI-SIL® IC Foley Catheter

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.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minneapolis,, Minnesota, United States, 55455
      • University of Minnesota Fairview medical center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: ICET™ TIC Foley Catheter; Route of Administration: Urinary Bladder Catheterization	Device: 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.; Other Names: ICET™ TIC Foley Catheter Device (TIC System)
ACTIVE_COMPARATOR: BARD® LUBRI-SIL® IC Foley Catheter; Route of Administration: Urinary Bladder Catheterization	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.; Other Names: BARD ® LUBRI-SIL® I.C. Foley Catheter Device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Subjects Affected, During Treatment and Follow-up Time Periods, by a Catheter Associated Urinary Tract Infection (CAUTI) Event After First CAUTI Event.	All randomized subjects will be followed until (1) up to 30th day from the time of catheterization or (2) the subject withdraws or is discharged from the hospital, whichever comes first and (3) 48 hours after the catheter is removed. Evaluable population (EP) refers to all randomized subjects successfully CZD & stayed on the CZD for ≥ 48 ± 24 hours or more without any systemic (postoperative) antibiotic for CZD/non-CZD related reasons. Subjects receiving an intercurrent course of systemic antibiotics lasting >24 hours other than surgical prophylaxis were considered non-evaluable in all analyses of effectiveness endpoints using the EP.	up to 30th day from the time of catheterization
The Proportion of Subjects With at Least One CAUTI	CAUTI is as determined by blinded investigator assessment per protocol definition. DAYS TO CAUTI = (DATE OF EVENT - DATE OF CZD INSERTION) + 1. Date of event for subjects who had CAUTI is the date of urine sample collection where the CAUTI criteria are met. Date of event for subjects who did not have CAUTI is the last available urine culture collection date from samples collected during & post CZD. p-values of time of CAUTI were obtained from log-rank test. p-values of Incidence of CAUTI were obtained from the Logistic Regression Model. Evaluable population (EP) refers to all randomized subjects successfully CZD & stayed on the CZD for ≥ 48 ± 24 hours or more without any systemic (postoperative) antibiotic for CZD/non-CZD related reasons. Subjects receiving an intercurrent course of systemic antibiotics lasting >24 hours other than surgical prophylaxis were considered non-evaluable in all analyses of effectiveness endpoints using the EP. CZD = Catheterized or catheter	48 ± 24 hours or more

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Proportion of Subjects With Symptomatic Urinary Tract Infection (SUTI)	Patients with catheter related SUTI are those having an indwelling urinary catheter in place at the time of specimen collection, or had an indwelling catheter within the previous 48 hours, and at least 1 of the following signs or symptoms with no other recognized cause: fever (>38°C), suprapubic tenderness, or costovertebral angle pain or tenderness and a positive urinalysis demonstrated by at least one of the following findings: a. positive dipstick for leukocyte esterase and/or nitrite, b. pyuria (urine specimen collected from the catheter with ≥10 white blood cells [WBC]/mm3 or ≥3 WBC/high power field of unspun urine), c. microorganisms seen on Gram stain of unspun urine and a positive urine	up to 30th day from the time of catheterization
The Proportion of Subjects With Asymptomatic Bacteremic Urinary Tract Infection (ABUTI)	Patients having an indwelling urinary catheter who have no signs or symptoms (i.e., no fever (>38°C), no urgency, frequency, dysuria, suprapubic tenderness, or costovertebral angle pain or tenderness), and a positive urine culture from urine collected from the catheter sampling port (or a midstream voided clean catch urine in subjects being followed for 48 hours post catheter removal) of >105 CFU/ml with no more than 2 species of uropathogen microorganisms and a positive blood culture with at least 1 matching uropathogen microorganism to the urine culture.	up to 30th day from the time of catheterization

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Organism Relation to CAUTI and TIC	Organisms found in relation to CAUTI events in TIC versus control.	up to 30th day from the time of catheterization

Collaborators and Investigators

• Sponsor: Innovative Chemical and Environmental Technologies, Inc
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Investigators: Principal Investigator: Susan E Kline, MD, University of Minnesota

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: May 1, 2012
• Primary Completion (ACTUAL): January 1, 2013
• Study Completion (ACTUAL): January 1, 2013

Study Registration Dates

• First Submitted: July 29, 2012
• First Submitted That Met QC Criteria: September 7, 2012
• First Posted (ESTIMATE): September 10, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): April 28, 2014
• Last Update Submitted That Met QC Criteria: April 9, 2014
• Last Verified: April 1, 2014

More Information

Terms related to this study

• Keywords: CAUTI; Catheter Associated Urinary Tract Infections
• Additional Relevant MeSH Terms: Urologic Diseases; Infections; Urinary Tract Infections
• Other Study ID Numbers: ICET-001; R44DK055891-06 (NIH)