Catheterization Clinical Trial
— SUCCESSOfficial title:
Study of a Urethral Catheter Coated With Eluting Silver Salts
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 |
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.
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Henry Ford Hospital | Detroit | Michigan |
Lead Sponsor | Collaborator |
---|---|
C. R. Bard |
United States,
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 |
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