Ignite Creation Date:
2024-05-06 @ 10:01 AM
Last Modification Date:
2024-10-26 @ 12:23 PM
Study NCT ID:
NCT03131609
Status:
COMPLETED
Last Update Posted:
2020-04-20
First Post:
2017-04-24
Brief Title:
Avoiding Bacterial Contamination of Clean Catch Urine Cultures in Ambulatory Patients in the Emergency Department
Sponsor:
Stanford University
Organization:
Stanford University
Study Overview
Official Title:
Avoiding Bacterial Contamination of Clean Catch Urine Cultures in Ambulatory Patients in the Emergency Department
Status:
COMPLETED
Status Verified Date:
2020-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to find the best cleaning and collection methods to obtain a non-contaminated clean catch mid-stream urine sample to diagnose suspected urinary tract infection UTI
Detailed Description:
BACKGROUND Urinary tract infection UTI is a major public health issue resulting in more than 3-million visits to Emergency Departments in the United States each year As part of the diagnostic work up a sterile urine sample is requested for culture The preferred urine specimen is a Clean Catch Midstream Urine Sample When patients are ambulatory and competent this is a self-obtained specimen in a private bathroom If the urine is not collected in a sterile manner the urine sample may be contaminated by bacteria that originate from the skin or genital area and not from the urinary tract This is often described by the clinical laboratory as mixed growth bacteria A contaminated sample may lead to a false-positive urine culture result In a non-contaminated urine specimen only a single bacterial growth is identified as the source of the infection Mixed bacterial flora with two or more microorganisms makes interpretation of the urine culture more difficult and prone to error The American College of Pathologists has published results of national laboratory surveys on Urine Culture Contamination in 1998 and 2008 that document the scope of the problem
SAMPLE Adult ambulatory patients in the Emergency Department who have a suspected UTI and have a urine culture ordered by a physician A total of 2000 patients will be enrolled 500 per group This is estimated to result in 600 urine samples 150 per group Written consent is not normally required for a self-obtained urine sample The study will be explained and participants will verbally consent or decline to participate as approved by the Institutional Review Board
SETTING Emergency Department of an academic medical center
METHOD This is a randomized controlled trial RCT with 4 groups that compare different patient self-cleaning and self-collection methods All study supplies materials are commercially available in the United States Each participant will be provided with study-specific visual aids for male or female participants and their randomly assigned group The four groups are
Group 1 Standard moist wipes and standard collection container Group 2 Silver impregnated moist wipes and standard collection container Group 3 Standard moist wipes and funnel collection container Group 4 Silver impregnated moist wipes and funnel collection container The urine samples will be sent to the Hospital Microbiology Laboratory for analysis Urine samples with a positive leuk-esterase pre-screen will be sent for urine culture
DATA ANALYSISThis study is powered to detect a large effect size change in any study groups 2 3 4 compared with control group 1 The sample size is sufficient to identify the methods with the lowest urine sample contamination rate
SAMPLE Adult ambulatory patients in the Emergency Department who have a suspected UTI and have a urine culture ordered by a physician A total of 2000 patients will be enrolled 500 per group This is estimated to result in 600 urine samples 150 per group Written consent is not normally required for a self-obtained urine sample The study will be explained and participants will verbally consent or decline to participate as approved by the Institutional Review Board
SETTING Emergency Department of an academic medical center
METHOD This is a randomized controlled trial RCT with 4 groups that compare different patient self-cleaning and self-collection methods All study supplies materials are commercially available in the United States Each participant will be provided with study-specific visual aids for male or female participants and their randomly assigned group The four groups are
Group 1 Standard moist wipes and standard collection container Group 2 Silver impregnated moist wipes and standard collection container Group 3 Standard moist wipes and funnel collection container Group 4 Silver impregnated moist wipes and funnel collection container The urine samples will be sent to the Hospital Microbiology Laboratory for analysis Urine samples with a positive leuk-esterase pre-screen will be sent for urine culture
DATA ANALYSISThis study is powered to detect a large effect size change in any study groups 2 3 4 compared with control group 1 The sample size is sufficient to identify the methods with the lowest urine sample contamination rate
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None