Urinary Tract Infection
Conditions
Keywords
Catheter Associated Urinary Tract Infections, CAUTI
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.
Interventions
DEVICEICET™ 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.
DEVICEBARD® 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.
Sponsors
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Innovative Chemical and Environmental Technologies, Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Organism Relation to CAUTI and TIC | up to 30th day from the time of catheterization | Organisms found in relation to CAUTI events in TIC versus control. |
Countries
United States
Participant flow
Recruitment details
Single Site Recruitment
Pre-assignment details
As of Study Termination: 100 Sbj signed Informed Consent, 95 Sbj RND Definitions: Safety Pop=Any Sbj receiving treatment after RND Evaluable Pop=All RND Sbj successfully CZD ≥ 72±24 hours w/out systemic (post-op) antibiotic for CZD/non-CZD related reasons. CZD=catheterized or catheter, Pop=Population, RND=Randomized, Sbj=Subject
Participants by arm
| Arm | Count |
|---|---|
| BARD® LUBRI-SIL® IC Foley Catheter Route of Administration: Urinary Bladder Catheterization
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. | 46 |
| ICET™ TIC Foley Catheter Route of Administration: Urinary Bladder Catheterization
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. | 49 |
| Total | 95 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Failed Inclusion/Exclusion | 3 | 0 |
| Overall Study | No Baseline Dips Stick & Urine Culture | 3 | 6 |
| Overall Study | No Daily Urine Sample Collected | 0 | 1 |
| Overall Study | No post-catheter sample collected | 11 | 4 |
| Overall Study | No Treatment Received | 1 | 3 |
Baseline characteristics
| Characteristic | ICET™ TIC Foley Catheter | BARD® LUBRI-SIL® IC Foley Catheter | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 49 Participants | 46 Participants | 95 Participants |
| Age, Continuous | 52.3 years STANDARD_DEVIATION 16.6 | 59 years STANDARD_DEVIATION 13.4 | 55.6 years STANDARD_DEVIATION 15.4 |
| Region of Enrollment United States | 49 participants | 46 participants | 95 participants |
| Sex: Female, Male Female | 30 Participants | 24 Participants | 54 Participants |
| Sex: Female, Male Male | 19 Participants | 22 Participants | 41 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 39 / 45 | 40 / 46 |
| serious Total, serious adverse events | 3 / 45 | 0 / 46 |
Outcome results
Primary
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.
Time frame: up to 30th day from the time of catheterization
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| BARD® LUBRI-SIL® IC Foley 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. | Number of Subject without Event | 37 participants |
| BARD® LUBRI-SIL® IC Foley 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. | Number of Subject with Event | 8 participants |
| BARD® LUBRI-SIL® IC Foley 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. | Number of Subjects Not Receiving Treatment | 1 participants |
| ICET™ TIC Foley 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. | Number of Subject without Event | 43 participants |
| ICET™ TIC Foley 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. | Number of Subject with Event | 3 participants |
| ICET™ TIC Foley 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. | Number of Subjects Not Receiving Treatment | 3 participants |
Primary
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
Time frame: 48 ± 24 hours or more
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| BARD® LUBRI-SIL® IC Foley Catheter | The Proportion of Subjects With at Least One CAUTI | Number of Subjects With Event | 7 participants |
| BARD® LUBRI-SIL® IC Foley Catheter | The Proportion of Subjects With at Least One CAUTI | Number of Subjects Without Events | 9 participants |
| ICET™ TIC Foley Catheter | The Proportion of Subjects With at Least One CAUTI | Number of Subjects With Event | 2 participants |
| ICET™ TIC Foley Catheter | The Proportion of Subjects With at Least One CAUTI | Number of Subjects Without Events | 12 participants |
Secondary
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.
Time frame: up to 30th day from the time of catheterization
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| BARD® LUBRI-SIL® IC Foley Catheter | The Proportion of Subjects With Asymptomatic Bacteremic Urinary Tract Infection (ABUTI) | Number of Subjects with ABUTI | 0 participants |
| BARD® LUBRI-SIL® IC Foley Catheter | The Proportion of Subjects With Asymptomatic Bacteremic Urinary Tract Infection (ABUTI) | Missing - Not Assessed | 8 participants |
| BARD® LUBRI-SIL® IC Foley Catheter | The Proportion of Subjects With Asymptomatic Bacteremic Urinary Tract Infection (ABUTI) | Number of Subjects without ABUTI | 38 participants |
| ICET™ TIC Foley Catheter | The Proportion of Subjects With Asymptomatic Bacteremic Urinary Tract Infection (ABUTI) | Number of Subjects with ABUTI | 0 participants |
| ICET™ TIC Foley Catheter | The Proportion of Subjects With Asymptomatic Bacteremic Urinary Tract Infection (ABUTI) | Number of Subjects without ABUTI | 37 participants |
| ICET™ TIC Foley Catheter | The Proportion of Subjects With Asymptomatic Bacteremic Urinary Tract Infection (ABUTI) | Missing - Not Assessed | 12 participants |
Secondary
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
Time frame: up to 30th day from the time of catheterization
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| BARD® LUBRI-SIL® IC Foley Catheter | The Proportion of Subjects With Symptomatic Urinary Tract Infection (SUTI) | Number of Subjects with SUTI | 0 Participants |
| BARD® LUBRI-SIL® IC Foley Catheter | The Proportion of Subjects With Symptomatic Urinary Tract Infection (SUTI) | Number of Subjects without SUTI | 45 Participants |
| BARD® LUBRI-SIL® IC Foley Catheter | The Proportion of Subjects With Symptomatic Urinary Tract Infection (SUTI) | Missing - Not Assessed | 1 Participants |
| ICET™ TIC Foley Catheter | The Proportion of Subjects With Symptomatic Urinary Tract Infection (SUTI) | Number of Subjects without SUTI | 45 Participants |
| ICET™ TIC Foley Catheter | The Proportion of Subjects With Symptomatic Urinary Tract Infection (SUTI) | Number of Subjects with SUTI | 1 Participants |
| ICET™ TIC Foley Catheter | The Proportion of Subjects With Symptomatic Urinary Tract Infection (SUTI) | Missing - Not Assessed | 3 Participants |
Other Pre-specified
Organism Relation to CAUTI and TIC
Organisms found in relation to CAUTI events in TIC versus control.
Time frame: up to 30th day from the time of catheterization
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| BARD® LUBRI-SIL® IC Foley Catheter | Organism Relation to CAUTI and TIC | Klebsiella Responsible for CAUTI Events | 1 participants |
| BARD® LUBRI-SIL® IC Foley Catheter | Organism Relation to CAUTI and TIC | E.Coli Responsible for CAUTI Events | 4 participants |
| BARD® LUBRI-SIL® IC Foley Catheter | Organism Relation to CAUTI and TIC | Enterobacter Responsible for CAUTI Events | 1 participants |
| BARD® LUBRI-SIL® IC Foley Catheter | Organism Relation to CAUTI and TIC | Enterococcus Responsible for CAUTI Events | 2 participants |
| BARD® LUBRI-SIL® IC Foley Catheter | Organism Relation to CAUTI and TIC | CoNS Responsible for CAUTI Events | 1 participants |
| BARD® LUBRI-SIL® IC Foley Catheter | Organism Relation to CAUTI and TIC | Candida Responsible for CAUTI Events | 0 participants |
| BARD® LUBRI-SIL® IC Foley Catheter | Organism Relation to CAUTI and TIC | Total Organisms Responsible for CAUTI Events | 10 participants |
| BARD® LUBRI-SIL® IC Foley Catheter | Organism Relation to CAUTI and TIC | Pseudomonas Responsible for CAUTI Events | 1 participants |
| ICET™ TIC Foley Catheter | Organism Relation to CAUTI and TIC | Total Organisms Responsible for CAUTI Events | 3 participants |
| ICET™ TIC Foley Catheter | Organism Relation to CAUTI and TIC | Pseudomonas Responsible for CAUTI Events | 0 participants |
| ICET™ TIC Foley Catheter | Organism Relation to CAUTI and TIC | Enterobacter Responsible for CAUTI Events | 0 participants |
| ICET™ TIC Foley Catheter | Organism Relation to CAUTI and TIC | Klebsiella Responsible for CAUTI Events | 0 participants |
| ICET™ TIC Foley Catheter | Organism Relation to CAUTI and TIC | Candida Responsible for CAUTI Events | 1 participants |
| ICET™ TIC Foley Catheter | Organism Relation to CAUTI and TIC | E.Coli Responsible for CAUTI Events | 0 participants |
| ICET™ TIC Foley Catheter | Organism Relation to CAUTI and TIC | Enterococcus Responsible for CAUTI Events | 2 participants |
| ICET™ TIC Foley Catheter | Organism Relation to CAUTI and TIC | CoNS Responsible for CAUTI Events | 0 participants |