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
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 April 17, 2014