ClinicalTrials.gg
Sign In
TerminatedNCT00482547SUCCESSUpdated Feb 28, 2017Results posted

Study of a Urethral Catheter Coated With Eluting Silver Salts (SUCCESS)

A Phase 4 interventional study of Hydrogel Silver Salts Coated Latex Urinary Catheter System and Bard silicone elastomer coated latex catheter system in Catheterization, sponsored by C. R. Bard. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-02-28.

Sponsored by C. R. Bard (part of Becton, Dickinson and Company) · Phase 4, Interventional, and Treatment

Why this study was terminated
Terminated for futility reasons.
Phase
Phase 4
Study type
Interventional
Enrollment
1,188
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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).

02

Conditions studied

  • Catheterization

Keywords

  • urinary tract infection
  • urinary catheter
03

In context

Urinary Tract Infections

779 studies on the registry are indexed under Urinary Tract Infections; 132 are open to participants now.

This study's enrollment of 1,188 is above the median of 130 across 544 interventional studies indexed under Urinary Tract Infections.

Browse Urinary Tract Infections studies →

Lead sponsor

C. R. Bard is the lead sponsor of 117 studies on the registry; 6 are open to participants now.

Of its 17 completed or terminated interventional studies of FDA-regulated products, 13 (76%) have results posted.

First submitted before C. R. Bard became part of Becton, Dickinson and Company.

Browse C. R. Bard studies →All Becton, Dickinson and Company studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
1,188 participants (actual)

Study arms

  • Experimental
    Silver-coated catheter

    Bard Hydrogel Silver Salts Coated Latex Urinary Catheter System

    Device: Hydrogel Silver Salts Coated Latex Urinary Catheter System

  • Placebo comparator
    Silicone-coated catheter

    Bard silicone elastomer coated latex catheter system

    Device: Bard silicone elastomer coated latex catheter system

Interventions

  • DeviceHydrogel Silver Salts Coated Latex Urinary Catheter System

    Silver-coated catheter

    Also known as: AgSC arm

  • DeviceBard silicone elastomer coated latex catheter system

    Silicone-coated catheter

    Also known as: SiCS arm

06

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

Other outcomes

  1. 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.

  2. 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

07

Results

Posted Jan 21, 2010
Limitations and caveats
Sample size calculations required 1244 Efficacy Evaluable 48 subjects, only 854 Efficacy Evaluable 48 subjects were enrolled, which does not allow for a fully powered study and there is the threat of a type II error (false negative result).

Participant flow

Twenty Investigators at 20 Investigative Sites enrolled a total of 1188 study subjects between June 28, 2007 and June 23, 2008.

Participant flow — Overall Study
MilestoneSilver-coated CatheterSilicone-coated Catheter
Started599589
Successful catheterization565568
48 hour evaluation426428
Completed426428
Not completed173161

Outcome measures

SecondaryPercentage 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
Reported as:
Number · Percentage of Participants with a bUTI
Percentage of Participants With a bUTI After Catheterization for >= 48 Hours
Percentage of Participants with a bUTISilver-coated CatheterSilicone-coated Catheter
Percentage of Participants With a bUTI After Catheterization for >= 48 Hours13.417.8
PrimaryTime 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
Reported as:
Median · Days
Time to Occurrence of Bacteriuric Urinary Tract Infection (bUTI) in Subjects Catheterized for >= 48 Hours
DaysSilver-coated CatheterSilicone-coated Catheter
Time to Occurrence of Bacteriuric Urinary Tract Infection (bUTI) in Subjects Catheterized for >= 48 Hours2.10 ± 1.992.06 ± 2.32
SecondaryTime 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
Reported as:
Median · Days
Time to Occurence of Symptomatic Urinary Tract Infection (sUTI) in Subjects Catheterized for >= 48 Hours
DaysSilver-coated CatheterSilicone-coated Catheter
Time to Occurence of Symptomatic Urinary Tract Infection (sUTI) in Subjects Catheterized for >= 48 Hours1.23 ± 1.751.62 ± 1.48
SecondaryTime 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
Reported as:
Median · Days
Time to Occurence of bUTI in Subjects Catheterized for >= 24 Hours
DaysSilver-coated CatheterSilicone-coated Catheter
Time to Occurence of bUTI in Subjects Catheterized for >= 24 Hours2.03 ± 1.982.04 ± 2.31
SecondaryTime 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
Reported as:
Median · Days
Time to Occurance of sUTI in Subjects Catheterized for >= 24 Hours
DaysSilver-coated CatheterSilicone-coated Catheter
Time to Occurance of sUTI in Subjects Catheterized for >= 24 Hours1.1039 ± 1.731.40 ± 1.47
SecondaryNumber 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
Reported as:
Number · Participants
Number of Participants With Bacteriuria at a Concentration of ≥ 10e3 < 10e5 CFU/mL
ParticipantsSilver-coated CatheterSilicone-coated Catheter
Number of Participants With Bacteriuria at a Concentration of ≥ 10e3 < 10e5 CFU/mL3835
Other pre-specifiedNumber 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.
Reported as:
Number · Participants
Number of Subjects With a bUTI Catheterized for >=48 Hours.
ParticipantsSilver-coated CatheterSilicone-coated Catheter
Number of Subjects With a bUTI Catheterized for >=48 Hours.5776
Other pre-specifiedNumber 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
Reported as:
Number · Participants
Number of Subjects With a sUTI Catheterized for >=48 Hours.
ParticipantsSilver-coated CatheterSilicone-coated Catheter
Number of Subjects With a sUTI Catheterized for >=48 Hours.3738

Adverse events

Collected over Adverse events were collected from the time of attempted or successful catheter insertion throughout the period of catheterization with the study catheter and for a period of 48 hours following study catheter removal, or until hospital discharge.. Non-serious events are listed at a 1.0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Silver-coated Catheter—47/565 (8.3%)15/565 (2.7%)
Silicone-coated Catheter—58/568 (10.2%)29/568 (5.1%)
Most frequent serious events
Showing 10 of 69
Most frequent serious events
EventSilver-coated CatheterSilicone-coated Catheter
Respiratory FailureRespiratory, thoracic and mediastinal disorders7/56514/568
AnemiaBlood and lymphatic system disorders4/5654/568
Atrial FibrillationCardiac disorders2/5654/568
Cardiac ArrestCardiac disorders1/5653/568
SepsisInfections and infestations2/5653/568
Respiratory DistressRespiratory, thoracic and mediastinal disorders2/5651/568
Ventricular TachycardiaCardiac disorders2/5652/568
Supraventricular TachycardiaCardiac disorders2/5650/568
Septic ShockInfections and infestations2/5651/568
HypotensionVascular disorders2/5651/568
Most frequent other events
Most frequent other events
EventSilver-coated CatheterSilicone-coated Catheter
HaematuriaRenal and urinary disorders12/56515/568
Respiratory FailureRespiratory, thoracic and mediastinal disorders7/56514/568

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Silver-coated CatheterSilicone-coated CatheterTotal
<=18 years000
Between 18 and 65 years302287589
>=65 years297302599
Age, Continuous
Age, Continuous(years)Silver-coated CatheterSilicone-coated CatheterTotal
Mean63.7 ± 15.964.3 ± 14.564.0 ± 15.2
Gender
Gender(Participants)Silver-coated CatheterSilicone-coated CatheterTotal
Female341332673
Male258257515
Region of Enrollment
Region of Enrollment(participants)Silver-coated CatheterSilicone-coated CatheterTotal
United States5995891188.0
08

Study locations

1 site
  • Henry Ford Hospital
    Detroit, Michigan 48202, United States
09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jun 2007, a primary completion of Apr 2008 and a completion of Aug 2008. It does not say whether these dates are actual or estimated.

Results were first posted in Jan 2010, 1 year 9 months after primary completion.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 4, 2007
First posted
Jun 5, 2007
Start
Jun 2007
Primary completionActual
Apr 2008
CompletionActual
Aug 2008
Results first posted
Jan 21, 2010
Last update
Feb 28, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 28, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00482547
Lead sponsor
C. R. Bard
Responsible party
Sponsor
First posted
Jun 5, 2007
Start date
Jun 2007
Primary completion
Apr 2008
Completion
Aug 2008
Results posted
Jan 21, 2010
Last update
Feb 28, 2017

Study contacts

Mark Rupp, MD
principal investigator · University of Nebraska

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Jan 2017. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Urinary Tract Infections →

Other studies from this sponsor

C. R. Bard →

Start the discussion