Study of a Urethral Catheter Coated With Eluting Silver Salts
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Catheterization
- Sponsor
- C. R. Bard
- Enrollment
- 1188
- Locations
- 1
- Primary Endpoint
- Time to Occurrence of Bacteriuric Urinary Tract Infection (bUTI) in Subjects Catheterized for >= 48 Hours
- Status
- Terminated
- Last Updated
- 9 years ago
Overview
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).
Investigators
Eligibility 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
Outcomes
Primary Outcomes
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 Outcomes
- Percentage of Participants With a bUTI After Catheterization for >= 48 Hours(>=48 hours to 10 days)
- Number of Participants With Bacteriuria at a Concentration of ≥ 10e3 < 10e5 CFU/mL(10 days)
- Time to Occurence of Symptomatic Urinary Tract Infection (sUTI) in Subjects Catheterized for >= 48 Hours(>= 48 hours to 10 days)
- Time to Occurance of sUTI in Subjects Catheterized for >= 24 Hours(>= 24 hours to 10 days)
- Time to Occurence of bUTI in Subjects Catheterized for >= 24 Hours(>= 24 hours to 10 days)