Catheterization
Conditions
Keywords
urinary tract infection, urinary catheter
Brief summary
Urinary catheters are often needed in hospital patients, but their use can increase the chance that a catheter associated urinary tract infection (called a CAUTI) may occur. This study will try to determine if patients who get a new silver coated catheter will have slower to time to development of a CAUTI compared to patients who get an uncoated catheter.
Detailed description
This study is a prospective, multicenter, randomized controlled pivotal study designed to compare the time to occurrence and incidence of CAUTI in subjects catheterized with a new hydrogel-silver salts latex catheter (test) to those of subjects catheterized with a silicone elastomer-coated latex catheter (control).
Interventions
DEVICEBard silicone elastomer coated latex catheter system
Silicone-coated catheter
DEVICEHydrogel Silver Salts Coated Latex Urinary Catheter System
Silver-coated catheter
Sponsors
C. R. Bard
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* male or female at least 18 years of age * life expectancy of 3 months or more * expected to require a urinary catheter for at least 48 hours
Exclusion criteria
* recent urinary tract surgery or instrumentation * presence of a urinary tract device * concurrent genitourinary tract infection * recent indwelling urinary catheter * requires use of a non-study urinary catheter
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Occurrence of Bacteriuric Urinary Tract Infection (bUTI) in Subjects Catheterized for >= 48 Hours | >=48 hours to 10 days | Time to occurrence of bUTI in subjects of both study groups who were catheterized with a study catheter for \>= 48 hours and who had evidence of bUTI after study catheter insertion. Subjects who did not have a bUTI are not included in the median calculation, so the median only includes data from non-censored observations. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Bacteriuria at a Concentration of ≥ 10e3 < 10e5 CFU/mL | 10 days | The number of subjects with bacteriuria levels ≥ 10e3 \< 10e5 CFU/mL who subsequently developed a bUTI or a sUTI |
| Time to Occurence of bUTI in Subjects Catheterized for >= 24 Hours | >= 24 hours to 10 days | Time to occurrence of bUTI in subjects of both study groups who were catheterized with a study catheter for \>= 24 hours and developed a bUTI at after catheter insertion. Subjects who did not have a bUTI are not included in the median calculation, so the median only includes data from non-censored observations. |
| Time to Occurance of sUTI in Subjects Catheterized for >= 24 Hours | >= 24 hours to 10 days | The time to occurrence of sUTI was measured as the time between catheter insertion and when the criteria for sUTI was met, up to 10 days after catheterization plus 48 hours after catheter removal. Subjects who did not have a sUTI are not included in the median calculation, so the median only includes data from non-censored observations. |
| Percentage of Participants With a bUTI After Catheterization for >= 48 Hours | >=48 hours to 10 days | The percentage of bUTI was calculated as the rate of new occurrence of bUTI in subjects of both study groups who had been catheterized with a study catheter for \>= 48 hours and who did not have evidence of bUTI at the time of study catheter insertion. |
| Time to Occurence of Symptomatic Urinary Tract Infection (sUTI) in Subjects Catheterized for >= 48 Hours | >= 48 hours to 10 days | The time to occurrence of sUTI was measured as the time between catheter insertion and when the criteria for sUTI was met, up to 10 days after catheterization plus 48 hours after catheter removal. Subjects who did not have a sUTI are not included in the median calculation, so the median only includes data from non-censored observations. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With a sUTI Catheterized for >=48 Hours. | From time of catheterization until 10 days or 48 hours after catheter was removed | sUTI occurences were counted in subjects of both study groups who had been catheterized with a study catheter for \>= 48 hours and who did not have evidence of bUTI at the time of study catheter insertion. |
| Number of Subjects With a bUTI Catheterized for >=48 Hours. | From time of catheterization until 10 days post catheterization or 48 hours after catheter removal. | bUTI occurences were counted in subjects of both study groups who had been catheterized with a study catheter for \>= 48 hours and who did not have evidence of bUTI at the time of study catheter insertion. |
Countries
United States
Participant flow
Recruitment details
Twenty Investigators at 20 Investigative Sites enrolled a total of 1188 study subjects between June 28, 2007 and June 23, 2008.
Pre-assignment details
Subjects judged by site personnel to require a urinary catheter for at least 48-72 hours were screened against the study inclusion/exclusion criteria. Those subjects meeting these criteria were offered participation in the study.
Participants by arm
| Arm | Count |
|---|---|
| Silver-coated Catheter Bard® Hydrogel Silver Salts Coated Latex Urinary Catheter | 599 |
| Silicone-coated Catheter silicone elastomer-coated latex catheter | 589 |
| Total | 1,188 |
Baseline characteristics
| Characteristic | Silicone-coated Catheter | Silver-coated Catheter | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 302 Participants | 297 Participants | 599 Participants |
| Age, Categorical Between 18 and 65 years | 287 Participants | 302 Participants | 589 Participants |
| Age, Continuous | 64.3 years STANDARD_DEVIATION 14.5 | 63.7 years STANDARD_DEVIATION 15.9 | 64.0 years STANDARD_DEVIATION 15.2 |
| Gender Female | 332 Participants | 341 Participants | 673 Participants |
| Gender Male | 257 Participants | 258 Participants | 515 Participants |
| Region of Enrollment United States | 589 participants | 599 participants | 1188.0 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 15 / 565 | 29 / 568 |
| serious Total, serious adverse events | 47 / 565 | 58 / 568 |
Outcome results
Primary
Time to Occurrence of Bacteriuric Urinary Tract Infection (bUTI) in Subjects Catheterized for >= 48 Hours
Time to occurrence of bUTI in subjects of both study groups who were catheterized with a study catheter for \>= 48 hours and who had evidence of bUTI after study catheter insertion. Subjects who did not have a bUTI are not included in the median calculation, so the median only includes data from non-censored observations.
Time frame: >=48 hours to 10 days
Population: Efficacy Evaluable (48) population: Intent-to-treat (ITT) subjects who were catheterized with a study catheter for ≥ 48 hours and who developed a bUTI after catheter insertion.
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Silver-coated Catheter | Time to Occurrence of Bacteriuric Urinary Tract Infection (bUTI) in Subjects Catheterized for >= 48 Hours | 2.10 Days | Standard Deviation 1.99 |
| Silicone-coated Catheter | Time to Occurrence of Bacteriuric Urinary Tract Infection (bUTI) in Subjects Catheterized for >= 48 Hours | 2.06 Days | Standard Deviation 2.32 |
Secondary
Number of Participants With Bacteriuria at a Concentration of ≥ 10e3 < 10e5 CFU/mL
The number of subjects with bacteriuria levels ≥ 10e3 \< 10e5 CFU/mL who subsequently developed a bUTI or a sUTI
Time frame: 10 days
Population: Safety population: ITT subjects who were catheterized with a study catheter. This population was used to assess tolerability and safety endpoints.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Silver-coated Catheter | Number of Participants With Bacteriuria at a Concentration of ≥ 10e3 < 10e5 CFU/mL | 38 Participants |
| Silicone-coated Catheter | Number of Participants With Bacteriuria at a Concentration of ≥ 10e3 < 10e5 CFU/mL | 35 Participants |
Secondary
Percentage of Participants With a bUTI After Catheterization for >= 48 Hours
The percentage of bUTI was calculated as the rate of new occurrence of bUTI in subjects of both study groups who had been catheterized with a study catheter for \>= 48 hours and who did not have evidence of bUTI at the time of study catheter insertion.
Time frame: >=48 hours to 10 days
Population: Efficacy Evaluable (48) population: ITT subjects who were catheterized with a study catheter for ≥ 48 hours and who did not have a bUTI in the baseline urine sample obtained at the time of catheter insertion.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Silver-coated Catheter | Percentage of Participants With a bUTI After Catheterization for >= 48 Hours | 13.4 Percentage of Participants with a bUTI |
| Silicone-coated Catheter | Percentage of Participants With a bUTI After Catheterization for >= 48 Hours | 17.8 Percentage of Participants with a bUTI |
Secondary
Time to Occurance of sUTI in Subjects Catheterized for >= 24 Hours
The time to occurrence of sUTI was measured as the time between catheter insertion and when the criteria for sUTI was met, up to 10 days after catheterization plus 48 hours after catheter removal. Subjects who did not have a sUTI are not included in the median calculation, so the median only includes data from non-censored observations.
Time frame: >= 24 hours to 10 days
Population: Efficacy Evaluable (24) population: ITT subjects who were catheterized with a study catheter for ≥ 24 hours and who developed a bUTI after catheter insertion.
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Silver-coated Catheter | Time to Occurance of sUTI in Subjects Catheterized for >= 24 Hours | 1.1039 Days | Standard Deviation 1.73 |
| Silicone-coated Catheter | Time to Occurance of sUTI in Subjects Catheterized for >= 24 Hours | 1.40 Days | Standard Deviation 1.47 |
Secondary
Time to Occurence of bUTI in Subjects Catheterized for >= 24 Hours
Time to occurrence of bUTI in subjects of both study groups who were catheterized with a study catheter for \>= 24 hours and developed a bUTI at after catheter insertion. Subjects who did not have a bUTI are not included in the median calculation, so the median only includes data from non-censored observations.
Time frame: >= 24 hours to 10 days
Population: Efficacy Evaluable (24) population: ITT subjects who were catheterized with a study catheter for ≥ 24 hours and who developed a bUTI after catheter insertion.
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Silver-coated Catheter | Time to Occurence of bUTI in Subjects Catheterized for >= 24 Hours | 2.03 Days | Standard Deviation 1.98 |
| Silicone-coated Catheter | Time to Occurence of bUTI in Subjects Catheterized for >= 24 Hours | 2.04 Days | Standard Deviation 2.31 |
Secondary
Time to Occurence of Symptomatic Urinary Tract Infection (sUTI) in Subjects Catheterized for >= 48 Hours
The time to occurrence of sUTI was measured as the time between catheter insertion and when the criteria for sUTI was met, up to 10 days after catheterization plus 48 hours after catheter removal. Subjects who did not have a sUTI are not included in the median calculation, so the median only includes data from non-censored observations.
Time frame: >= 48 hours to 10 days
Population: Efficacy Evaluable (48) population: ITT subjects who were catheterized with a study catheter for ≥ 48 hours and who developed a sUTI after catheter insertion.
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Silver-coated Catheter | Time to Occurence of Symptomatic Urinary Tract Infection (sUTI) in Subjects Catheterized for >= 48 Hours | 1.23 Days | Standard Deviation 1.75 |
| Silicone-coated Catheter | Time to Occurence of Symptomatic Urinary Tract Infection (sUTI) in Subjects Catheterized for >= 48 Hours | 1.62 Days | Standard Deviation 1.48 |
Other Pre-specified
Number of Subjects With a bUTI Catheterized for >=48 Hours.
bUTI occurences were counted in subjects of both study groups who had been catheterized with a study catheter for \>= 48 hours and who did not have evidence of bUTI at the time of study catheter insertion.
Time frame: From time of catheterization until 10 days post catheterization or 48 hours after catheter removal.
Population: Efficacy Evaluable (48) population: ITT subjects who were catheterized with a study catheter for ≥ 48 hours and who did not have a bUTI in the baseline urine sample obtained at the time of catheter insertion.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Silver-coated Catheter | Number of Subjects With a bUTI Catheterized for >=48 Hours. | 57 Participants |
| Silicone-coated Catheter | Number of Subjects With a bUTI Catheterized for >=48 Hours. | 76 Participants |
Other Pre-specified
Number of Subjects With a sUTI Catheterized for >=48 Hours.
sUTI occurences were counted in subjects of both study groups who had been catheterized with a study catheter for \>= 48 hours and who did not have evidence of bUTI at the time of study catheter insertion.
Time frame: From time of catheterization until 10 days or 48 hours after catheter was removed
Population: Efficacy Evaluable (48) population: ITT subjects who were catheterized with a study catheter for ≥ 48 hours and who did not have a bUTI in the baseline urine sample obtained at the time of catheter insertion.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Silver-coated Catheter | Number of Subjects With a sUTI Catheterized for >=48 Hours. | 37 Participants |
| Silicone-coated Catheter | Number of Subjects With a sUTI Catheterized for >=48 Hours. | 38 Participants |