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

Phase 4

Terminated

• Conditions: Catheterization
• Interventions: Device: Bard silicone elastomer coated latex catheter system; Device: Hydrogel Silver Salts Coated Latex Urinary Catheter System

• Registration Number: NCT00482547
• Lead Sponsor: C. R. Bard

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.

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 Timeline

• Study Start: 2007-06
• Study First Submitted: 2007-06-04
• Study First Submitted QC: 2007-06-04
• Study First Posted: 2007-06-05
• Primary Completion: 2008-04
• Study Completion: 2008-08
• Results First Submitted: 2009-04-06
• Results First Submitted QC: 2009-12-17
• Results First Posted: 2010-01-21
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-13
• Last Update Posted: 2017-02-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1188

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Silicone-coated catheter	Bard silicone elastomer coated latex catheter system	Bard silicone elastomer coated latex catheter system
Silver-coated catheter	Hydrogel Silver Salts Coated Latex Urinary Catheter System	Bard Hydrogel Silver Salts Coated Latex Urinary Catheter System

Primary Outcome Measures

Name	Time	Method
Time to Occurrence of Bacteriuric Urinary Tract Infection (bUTI) in Subjects Catheterized for >= 48 Hours	>=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

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

Trial Locations

Locations (1)

Henry Ford Hospital; 🇺🇸 Detroit, Michigan, United States