Ignite Creation Date:
2025-12-24 @ 3:54 PM
Ignite Modification Date:
2025-12-27 @ 4:46 PM
Study NCT ID:
NCT04686292
Status:
COMPLETED
Last Update Posted:
2022-09-14
First Post:
2020-12-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Diagnostic Accuracy of Urine Flow Cytometry in Excluding Bacteruria
Sponsor:
University of Southern Denmark
Organization:
Study Overview
Official Title:
Diagnostic Accuracy of Urine Flow Cytometry in Diagnosing and Excluding Bacteruria in the Emergency Department
Status:
COMPLETED
Status Verified Date:
2022-09
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:
A more rapid test for bacteriuria is desired. This will exclude the patients not having bacteriuria, which will contribute to a more rapid and accurate diagnosis of infectious diseases. The aim of the study is to investigate the diagnostic accuracy of point-of-care urine flow cytometry on diagnosing and excluding bacteriuria
Detailed Description:
A prerequisite for the appropriate use of antibiotics is timely access to accurate diagnostic tests, since treatment of acute infections should be initiated within a few hours to avoid serious complications such as bacteremia, sepsis, organ failure, septic shock and death.
The diagnosis of urinary tract infections including acute pyelonephritis (APN) is difficult due to often weak and non-specific symptoms and high incidence of asymptomatic bacteruria in especially elderly patients. The diagnosis is verified by significant bacteriuria in urine culture.
Unfortunately, the time from urine sample to result from urine cultures is more than 24 hours days. Urine test strips are unreliable with low specificity and low predictive values. Therefore, a point-of-care (POC) test is desired, which can provide rapid results and quickly identify a bacteriuria. One such tool may be urine flow cytometry (UFC), which has shown promising diagnostic value for the exclusion of bacteriuria with a high negative predictive value. However, better documentation for its use as an ED diagnostic screening method is needed.
The aim of the study is to investigate the diagnostic accuracy of POC-UFC on diagnosing and excluding bacteriuria? Our hypothesis is that by excluding patients not having bacteriuria, it will contribute to a more rapid and accurate diagnosis
The diagnosis of urinary tract infections including acute pyelonephritis (APN) is difficult due to often weak and non-specific symptoms and high incidence of asymptomatic bacteruria in especially elderly patients. The diagnosis is verified by significant bacteriuria in urine culture.
Unfortunately, the time from urine sample to result from urine cultures is more than 24 hours days. Urine test strips are unreliable with low specificity and low predictive values. Therefore, a point-of-care (POC) test is desired, which can provide rapid results and quickly identify a bacteriuria. One such tool may be urine flow cytometry (UFC), which has shown promising diagnostic value for the exclusion of bacteriuria with a high negative predictive value. However, better documentation for its use as an ED diagnostic screening method is needed.
The aim of the study is to investigate the diagnostic accuracy of POC-UFC on diagnosing and excluding bacteriuria? Our hypothesis is that by excluding patients not having bacteriuria, it will contribute to a more rapid and accurate diagnosis
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: