Text Size

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

This study is currently recruiting participants.
Verified September 2012 by Innovative Chemical and Environmental Technologies, Inc
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Innovative Chemical and Environmental Technologies, Inc
ClinicalTrials.gov Identifier:
NCT01681511
First received: July 29, 2012
Last updated: September 7, 2012
Last verified: September 2012
History of Changes
  Purpose

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.


Condition Intervention
Urinary Tract Infection
 Device: ICET™ TIC Foley Catheter
Device: BARD® LUBRI-SIL® IC Foley Catheter

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Innovative Chemical and Environmental Technologies, Inc:

Primary Outcome Measures:
  • The time to first Catheter Associated Urinary Tract Infection (CAUTI) event [ Time Frame: up to 30th day from the time of catheterization ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • The proportion of subjects with Symptomatic Urinary Tract Infection (SUTI) [ Time Frame: up to 30th day from the time of catheterization ] [ Designated as safety issue: No ]
    The proportion of SUTI in subjects from the time of catheterization up to 30 days from a single urine specimen collected from the catheter port or from the midstream clean catch urine collected 48 hours after catheter removal or until subject withdrawal or discharge from hospital.

  • The proportion of subjects with Asymptomatic Bacteremic Urinary Tract Infection (ABUTI) [ Time Frame: up to 30th day from the time of catheterization ] [ Designated as safety issue: No ]
    The proportion of ABUTI in subjects from the time of catheterization up to 30 days or 48 hours after catheter removal or until subject withdrawal or discharge from hospital.

  • Safety and tolerance of TIC system [ Time Frame: up to 30th day from the time of catheterization ] [ Designated as safety issue: Yes ]
    Safety will be assessed through Adverse Events and tolerance of the ICET TIC Foley catheter.


Estimated Enrollment: 120
Study Start Date: May 2012
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: BARD ® LUBRI-SIL® I.C. Foley Catheter Device

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01681511

Locations
United States, Minnesota
University of Minnesota Fairview medical center Recruiting
Minneapolis,, Minnesota, United States, 55455
Contact: Susan E Kline, MD     612-626-3662     kline003@umn.edu    
Sponsors and Collaborators
Innovative Chemical and Environmental Technologies, Inc
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
Principal Investigator: Susan E Kline, MD University of Minnesota - Clinical and Translational Science Institute
  More Information

No publications provided

Responsible Party: Innovative Chemical and Environmental Technologies, Inc
ClinicalTrials.gov Identifier: NCT01681511     History of Changes
Other Study ID Numbers: ICET-001, R44DK055891-06
Study First Received: July 29, 2012
Last Updated: September 7, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Innovative Chemical and Environmental Technologies, Inc:
Catheter Associated Urinary Tract Infections
CAUTI

Additional relevant MeSH terms:
Urinary Tract Infections
Infection
Urologic Diseases
 Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013