Back to resultsA Trial for the Safety and Effectiveness of a Novel Antimicrobial-Coated Foley Catheter for Reduction of CAUTI.
Primary Purpose
Urinary Tract Infection
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ICET™ TIC Foley Catheter
BARD® LUBRI-SIL® IC Foley Catheter
Sponsored by
About this trial
This is an interventional prevention trial for Urinary Tract Infection focused on measuring Catheter Associated Urinary Tract Infections, CAUTI
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- University of Minnesota Fairview medical center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
ICET™ TIC Foley Catheter
BARD® LUBRI-SIL® IC Foley Catheter
Arm Description
Route of Administration: Urinary Bladder Catheterization
Route of Administration: Urinary Bladder Catheterization
Outcomes
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.
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
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)
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)
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.
Full Information
NCT ID
NCT01681511
First Posted
July 29, 2012
Last Updated
April 9, 2014
Sponsor
Innovative Chemical and Environmental Technologies, Inc
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
1. Study Identification
Unique Protocol Identification Number
NCT01681511
Brief Title
A Trial for the Safety and Effectiveness of a Novel Antimicrobial-Coated Foley Catheter for Reduction of CAUTI.
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2014
Overall Recruitment Status
Terminated
Why Stopped
Business Reasons
Study Start Date
May 2012 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
January 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Innovative Chemical and Environmental Technologies, Inc
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Tract Infection
Keywords
Catheter Associated Urinary Tract Infections, CAUTI
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ICET™ TIC Foley Catheter
Arm Type
Experimental
Arm Description
Route of Administration: Urinary Bladder Catheterization
Arm Title
BARD® LUBRI-SIL® IC Foley Catheter
Arm Type
Active Comparator
Arm Description
Route of Administration: Urinary Bladder Catheterization
Intervention Type
Device
Intervention Name(s)
ICET™ TIC Foley Catheter
Other Intervention Name(s)
ICET™ TIC Foley Catheter Device (TIC System)
Intervention Description
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
Intervention Name(s)
BARD® LUBRI-SIL® IC Foley Catheter
Other Intervention Name(s)
BARD ® LUBRI-SIL® I.C. Foley Catheter Device
Intervention Description
The LUBRI-SIL® I.C. antimicrobial 100% silicone Foley catheter incorporates a formulation consisting of BACTI-GUARD®* silver alloy coating and BARD® hydrogel.
Primary Outcome Measure Information:
Title
Number of Subjects Affected, During Treatment and Follow-up Time Periods, by a Catheter Associated Urinary Tract Infection (CAUTI) Event After First CAUTI Event.
Description
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.
Time Frame
up to 30th day from the time of catheterization
Title
The Proportion of Subjects With at Least One CAUTI
Description
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
Time Frame
48 ± 24 hours or more
Secondary Outcome Measure Information:
Title
The Proportion of Subjects With Symptomatic Urinary Tract Infection (SUTI)
Description
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
Time Frame
up to 30th day from the time of catheterization
Title
The Proportion of Subjects With Asymptomatic Bacteremic Urinary Tract Infection (ABUTI)
Description
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.
Time Frame
up to 30th day from the time of catheterization
Other Pre-specified Outcome Measures:
Title
Organism Relation to CAUTI and TIC
Description
Organisms found in relation to CAUTI events in TIC versus control.
Time Frame
up to 30th day from the time of catheterization
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susan E Kline, MD
Organizational Affiliation
University of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Minnesota Fairview medical center
City
Minneapolis,
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
25728152
Citation
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.
Results Reference
derived
Learn more about this trial
A Trial for the Safety and Effectiveness of a Novel Antimicrobial-Coated Foley Catheter for Reduction of CAUTI.
We'll reach out to this number within 24 hrs