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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00482547
Recruitment Status : Terminated (Terminated for futility reasons.)
First Posted : June 5, 2007
Results First Posted : January 21, 2010
Last Update Posted : February 28, 2017
Sponsor:
Information provided by (Responsible Party):
C. R. Bard

Tracking Information
First Submitted Date  ICMJE June 4, 2007
First Posted Date  ICMJE June 5, 2007
Results First Submitted Date  ICMJE April 6, 2009
Results First Posted Date  ICMJE January 21, 2010
Last Update Posted Date February 28, 2017
Study Start Date  ICMJE June 2007
Actual Primary Completion Date April 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 13, 2017)
Time to Occurrence of Bacteriuric Urinary Tract Infection (bUTI) in Subjects Catheterized for >= 48 Hours [ Time Frame: >=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.
Original Primary Outcome Measures  ICMJE
 (submitted: June 4, 2007)
To determine whether time to occurrence of CAUTI, defined as <3 organisms at a concentration of 10e5 CFU/mL or greater, will be delayed in test subjects catheterized for > 48 hours. [ Time Frame: 12 days ]
Change History Complete list of historical versions of study NCT00482547 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 13, 2017)
  • Percentage of Participants With a bUTI After Catheterization for >= 48 Hours [ Time Frame: >=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 [ Time Frame: >= 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.
  • Time to Occurence of bUTI in Subjects Catheterized for >= 24 Hours [ Time Frame: >= 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 [ Time Frame: >= 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.
  • Number of Participants With Bacteriuria at a Concentration of ≥ 10e3 < 10e5 CFU/mL [ Time Frame: 10 days ]
    The number of subjects with bacteriuria levels ≥ 10e3 < 10e5 CFU/mL who subsequently developed a bUTI or a sUTI
Original Secondary Outcome Measures  ICMJE
 (submitted: June 4, 2007)
To determine if the incidence of CAUTI and the time to onset and incidence of symptomatic CAUTI (as defined by CDC criteria) will be lower or delayed in the test group. [ Time Frame: 12 days ]
Current Other Pre-specified Outcome Measures
 (submitted: January 13, 2017)
  • Number of Subjects With a bUTI Catheterized for >=48 Hours. [ Time Frame: 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.
  • Number of Subjects With a sUTI Catheterized for >=48 Hours. [ Time Frame: 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.
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of a Urethral Catheter Coated With Eluting Silver Salts (SUCCESS)
Official Title  ICMJE Study of a Urethral Catheter Coated With Eluting Silver Salts
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).
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Catheterization
Intervention  ICMJE
  • Device: Hydrogel Silver Salts Coated Latex Urinary Catheter System
    Silver-coated catheter
    Other Name: AgSC arm
  • Device: Bard silicone elastomer coated latex catheter system
    Silicone-coated catheter
    Other Name: SiCS arm
Study Arms  ICMJE
  • Experimental: Silver-coated catheter
    Bard Hydrogel Silver Salts Coated Latex Urinary Catheter System
    Intervention: Device: Hydrogel Silver Salts Coated Latex Urinary Catheter System
  • Placebo Comparator: Silicone-coated catheter
    Bard silicone elastomer coated latex catheter system
    Intervention: Device: Bard silicone elastomer coated latex catheter system
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: December 17, 2009)
1188
Original Estimated Enrollment  ICMJE
 (submitted: June 4, 2007)
1500
Actual Study Completion Date  ICMJE August 2008
Actual Primary Completion Date April 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00482547
Other Study ID Numbers  ICMJE BMD-6003
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party C. R. Bard
Study Sponsor  ICMJE C. R. Bard
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Mark Rupp, MD University of Nebraska
PRS Account C. R. Bard
Verification Date January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP