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

This study has been terminated.
(Terminated for futility reasons.)
Sponsor:
Information provided by:
C. R. Bard
ClinicalTrials.gov Identifier:
NCT00482547
First received: June 4, 2007
Last updated: January 20, 2010
Last verified: January 2010
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percentage of Participants With a bUTI After Catheterization for >= 48 Hours [ Time Frame: >=48 hours to 10 days ] [ Designated as safety issue: No ]
  • Time to Occurence of Symptomatic Urinary Tract Infection (sUTI) in Subjects Catheterized for >= 48 Hours [ Time Frame: >= 48 hours to 10 days ] [ Designated as safety issue: No ]
  • Time to Occurence of bUTI in Subjects Catheterized for >= 24 Hours [ Time Frame: >= 24 hours to 10 days ] [ Designated as safety issue: No ]
  • Time to Occurance of sUTI in Subjects Catheterized for >= 24 Hours [ Time Frame: >= 24 hours to 10 days ] [ Designated as safety issue: No ]
  • Number of Participants With Bacteriuria at a Concentration of ≥ 10e3 < 10e5 CFU/mL [ Time Frame: 10 days ] [ Designated as safety issue: No ]

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
Genders Eligible for Study:   Both
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

No publications provided

Responsible Party: Joan Dulin/Project Manager, CR Bard, Inc.
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 20, 2010
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on August 28, 2014