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

Study of a Urethral Catheter Coated With Eluting Silver Salts

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.

Study Overview

• Status: Terminated
• Conditions: Catheterization
• Intervention / Treatment: Device: Hydrogel Silver Salts Coated Latex Urinary Catheter System; Device: Bard silicone elastomer coated latex catheter system

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: Interventional
• Enrollment (Actual): 1188
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Henry Ford Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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 Names: SiCS arm

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to Occurrence of Bacteriuric Urinary Tract Infection (bUTI) in Subjects Catheterized for >= 48 Hours	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.	>=48 hours to 10 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With a bUTI After Catheterization for >= 48 Hours	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.	>=48 hours to 10 days
Time to Occurence of Symptomatic Urinary Tract Infection (sUTI) in Subjects Catheterized for >= 48 Hours	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.	>= 48 hours to 10 days
Time to Occurence of bUTI in Subjects Catheterized for >= 24 Hours	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.	>= 24 hours to 10 days
Time to Occurance of sUTI in Subjects Catheterized for >= 24 Hours	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.	>= 24 hours to 10 days
Number of Participants With Bacteriuria at a Concentration of ≥ 10e3 < 10e5 CFU/mL	The number of subjects with bacteriuria levels ≥ 10e3 < 10e5 CFU/mL who subsequently developed a bUTI or a sUTI	10 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Subjects With a bUTI Catheterized for >=48 Hours.	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.	From time of catheterization until 10 days post catheterization or 48 hours after catheter removal.
Number of Subjects With a sUTI Catheterized for >=48 Hours.	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.	From time of catheterization until 10 days or 48 hours after catheter was removed

Collaborators and Investigators

• Sponsor: C. R. Bard
• Investigators: Principal Investigator: Mark Rupp, MD, University of Nebraska

Study record dates

Study Major Dates

• Study Start: June 1, 2007
• Primary Completion (ACTUAL): April 1, 2008
• Study Completion (ACTUAL): August 1, 2008

Study Registration Dates

• First Submitted: June 4, 2007
• First Submitted That Met QC Criteria: June 4, 2007
• First Posted (ESTIMATE): June 5, 2007

Study Record Updates

• Last Update Posted (ACTUAL): February 28, 2017
• Last Update Submitted That Met QC Criteria: January 13, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Keywords: urinary tract infection; urinary catheter
• Other Study ID Numbers: BMD-6003