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

Not Applicable

Terminated

Conditions: Urinary Tract Infection

Interventions: Device: ICET™ TIC Foley Catheter
Device: BARD® LUBRI-SIL® IC Foley Catheter

Registration Number: NCT01681511

Lead Sponsor: Innovative Chemical and Environmental Technologies, Inc

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.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 100

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ICET™ TIC Foley Catheter	ICET™ TIC Foley Catheter	Route of Administration: Urinary Bladder Catheterization
BARD® LUBRI-SIL® IC Foley Catheter	BARD® LUBRI-SIL® IC Foley Catheter	Route of Administration: Urinary Bladder Catheterization

Primary Outcome Measures

Name	Time	Method
The Proportion of Subjects With at Least One CAUTI	48 ± 24 hours or more	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
Number of Subjects Affected, During Treatment and Follow-up Time Periods, by a Catheter Associated Urinary Tract Infection (CAUTI) Event After First CAUTI Event.	up to 30th day from the time of catheterization	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.

Secondary Outcome Measures

Name	Time	Method
The Proportion of Subjects With Symptomatic Urinary Tract Infection (SUTI)	up to 30th day from the time of catheterization	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)	up to 30th day from the time of catheterization	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.