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

Catheterization Clinical Trial

— SUCCESS  

Official title:

Study of a Urethral Catheter Coated With Eluting Silver Salts

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00482547
• Other study ID #: BMD-6003
• Status: Terminated
• Phase: Phase 4
• First received: June 4, 2007
• Last updated: January 20, 2010
• Start date: June 2007
• Est. completion date: August 2008

Study information

• Verified date: January 2010
• Source: C. R. Bard
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1188
• Est. completion date: August 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Catheterization

Intervention

Device:
• Hydrogel Silver Salts Coated Latex Urinary Catheter System
Silver-coated catheter
• Bard silicone elastomer coated latex catheter system
Silicone-coated catheter

Locations

Country	Name	City	State
United States	Henry Ford Hospital	Detroit	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
C. R. Bard

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to Occurrence of Bacteriuric Urinary Tract Infection (bUTI) in Subjects Catheterized for >= 48 Hours		>=48 hours to 10 days	No
Secondary	Percentage of Participants With a bUTI After Catheterization for >= 48 Hours		>=48 hours to 10 days	No
Secondary	Time to Occurence of Symptomatic Urinary Tract Infection (sUTI) in Subjects Catheterized for >= 48 Hours		>= 48 hours to 10 days	No
Secondary	Time to Occurence of bUTI in Subjects Catheterized for >= 24 Hours		>= 24 hours to 10 days	No
Secondary	Time to Occurance of sUTI in Subjects Catheterized for >= 24 Hours		>= 24 hours to 10 days	No
Secondary	Number of Participants With Bacteriuria at a Concentration of = 10e3 < 10e5 CFU/mL		10 days	No