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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
1,188
Silver-coated catheter
Silicone-coated catheter
Henry Ford Hospital
Detroit, Michigan, United States
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.
Time frame: >=48 hours to 10 days
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.
Time frame: >=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.
Time frame: >= 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.
Time frame: >= 24 hours to 10 days
Time to Occurance of sUTI in Subjects Catheterized for >= 24 Hours
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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 frame: >= 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
Time frame: 10 days