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

This study has been terminated.
(Terminated for futility reasons.)
Sponsor:
Information provided by (Responsible Party):
C. R. Bard
ClinicalTrials.gov Identifier:
NCT00482547
First received: June 4, 2007
Last updated: January 13, 2017
Last verified: January 2017
  Purpose
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.

Condition Intervention Phase
Catheterization Device: Hydrogel Silver Salts Coated Latex Urinary Catheter System Device: Bard silicone elastomer coated latex catheter system Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Study of a Urethral Catheter Coated With Eluting Silver Salts

Resource links provided by NLM:


Further study details as provided by C. R. Bard:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Other Outcome Measures:
  • 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.


Enrollment: 1188
Study Start Date: June 2007
Study Completion Date: August 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Silver-coated catheter
Bard Hydrogel Silver Salts Coated Latex Urinary Catheter System
Device: Hydrogel Silver Salts Coated Latex Urinary Catheter System
Silver-coated catheter
Other Name: AgSC arm
Placebo Comparator: Silicone-coated catheter
Bard silicone elastomer coated latex catheter system
Device: Bard silicone elastomer coated latex catheter system
Silicone-coated catheter
Other Name: SiCS arm

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).
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00482547

Locations
United States, Michigan
Henry Ford Hospital
Detroit, Michigan, United States, 48202
Sponsors and Collaborators
C. R. Bard
Investigators
Principal Investigator: Mark Rupp, MD University of Nebraska
  More Information

Responsible Party: C. R. Bard
ClinicalTrials.gov Identifier: NCT00482547     History of Changes
Other Study ID Numbers: BMD-6003
Study First Received: June 4, 2007
Results First Received: April 6, 2009
Last Updated: January 13, 2017

Keywords provided by C. R. Bard:
urinary tract infection
urinary catheter

ClinicalTrials.gov processed this record on August 18, 2017