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

NCT01681511 | Terminated Results DMC

• 2 other identifiers: ICET-001R44DK055891-06
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Urinary Tract Infection

Keywords

Catheter Associated Urinary Tract Infections; CAUTI

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• The Proportion of Subjects With Symptomatic Urinary Tract Infection (SUTI)

  up to 30th day from the time of catheterization

• The Proportion of Subjects With Asymptomatic Bacteremic Urinary Tract Infection (ABUTI)

  up to 30th day from the time of catheterization

Other Outcomes (1)

• Organism Relation to CAUTI and TIC

  up to 30th day from the time of catheterization

Study Arms (2)

ICET™ TIC Foley Catheter

EXPERIMENTAL

Route of Administration: Urinary Bladder Catheterization

Device: ICET™ TIC Foley Catheter

BARD® LUBRI-SIL® IC Foley Catheter

ACTIVE COMPARATOR

Route of Administration: Urinary Bladder Catheterization

Device: BARD® LUBRI-SIL® IC Foley Catheter

Interventions

ICET™ TIC Foley Catheter 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.

Also known as: ICET™ TIC Foley Catheter Device (TIC System)

ICET™ TIC Foley Catheter

BARD® LUBRI-SIL® IC Foley Catheter DEVICE

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

Also known as: BARD ® LUBRI-SIL® I.C. Foley Catheter Device

BARD® LUBRI-SIL® IC Foley Catheter

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Innovative Chemical and Environmental Technologies, Inc: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

University of Minnesota Fairview medical center

Minneapolis, Minnesota, 55455, United States

Location

Related Publications (1)

• 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.

  PMID: 25728152 DERIVED

MeSH Terms

Conditions

Urinary Tract Infections

Condition Hierarchy (Ancestors)

Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Limitations and Caveats

Study could not be completed for business reasons.

Results Point of Contact

• Title: Dr. Shantha Sarangapani
• Organization: ICET, Inc.

Shantha@icetinc.com

781-769-6064

Study Officials

• Susan E Kline, MD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2012
• First Posted: September 10, 2012
• Study Start: May 1, 2012
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: April 28, 2014
• Results First Posted: April 10, 2014

Record last verified: 2014-04

Locations

US (1)