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

This study has been terminated.
(Business Reasons)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Innovative Chemical and Environmental Technologies, Inc
ClinicalTrials.gov Identifier:
NCT01681511
First received: July 29, 2012
Last updated: April 9, 2014
Last verified: April 2014
  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:


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

Primary Outcome Measures:
  • Number of Subjects Affected, During Treatment and Follow-up Time Periods, by a Catheter Associated Urinary Tract Infection (CAUTI) Event After First 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.

    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.


  • The Proportion of Subjects With at Least One CAUTI [ Time Frame: 48 ± 24 hours or more ] [ Designated as safety issue: No ]

    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



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 ]
    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

  • 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 ]
    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.


Other Outcome Measures:
  • Organism Relation to CAUTI and TIC [ Time Frame: up to 30th day from the time of catheterization ] [ Designated as safety issue: No ]
    Organisms found in relation to CAUTI events in TIC versus control.


Enrollment: 100
Study Start Date: May 2012
Study Completion Date: January 2013
Primary Completion Date: January 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01681511

Locations
United States, Minnesota
University of Minnesota Fairview medical center
Minneapolis,, Minnesota, United States, 55455
Sponsors and Collaborators
Innovative Chemical and Environmental Technologies, Inc
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
Results First Received: October 29, 2013
Last Updated: April 9, 2014
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:
Infection
Communicable Diseases
Urinary Tract Infections
Urologic Diseases
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 16, 2014