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

Study 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).

Official Title
-----------------
Study of a Urethral Catheter Coated With Eluting Silver Salts

Conditions
-----------------
Catheterization

Intervention / Treatment
-----------------
* Device: Hydrogel Silver Salts Coated Latex Urinary Catheter System
* Device: Bard silicone elastomer coated latex catheter system


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Silver-coated catheter<br>Bard Hydrogel Silver Salts Coated Latex Urinary Catheter System | Device: Hydrogel Silver Salts Coated Latex Urinary Catheter System<br>* Silver-coated catheter<br>* Other names: AgSC arm;|
| Placebo Comparator: Silicone-coated catheter<br>Bard silicone elastomer coated latex catheter system | Device: Bard silicone elastomer coated latex catheter system<br>* Silicone-coated catheter<br>* 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
urinary tract infection, urinary catheter