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

• ClinicalTrials.gov Identifier: NCT00482547
• Recruitment Status: Terminated
• First Posted: June 5, 2007
• Results First Posted: January 21, 2010
• Last Update Posted: February 28, 2017
• Sponsor: C. R. Bard
• Information provided by (Responsible Party): C. R. Bard

Study Description

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.

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

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 1188 participants
• 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
• Study Start Date: June 2007
• Actual Primary Completion Date: April 2008
• Actual Study Completion Date: August 2008

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

1. 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 :

1. 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.
2. 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.
3. 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.
4. 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.
5. 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:

1. 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.
2. 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• 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

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
• Other Study ID Numbers: BMD-6003
• First Posted: June 5, 2007
• Results First Posted: January 21, 2010
• Last Update Posted: February 28, 2017
• Last Verified: January 2017

Keywords provided by C. R. Bard:

urinary tract infection; urinary catheter