Diagnostic Accuracy of Urine Flow Cytometry in Excluding Bacteruria
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|ClinicalTrials.gov Identifier: NCT04686292|
Recruitment Status : Recruiting
First Posted : December 28, 2020
Last Update Posted : March 3, 2021
|Condition or disease||Intervention/treatment|
|Acute Infection||Diagnostic Test: urine flow cytometry|
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
|Study Type :||Observational|
|Estimated Enrollment :||1000 participants|
|Official Title:||Diagnostic Accuracy of Urine Flow Cytometry in Diagnosing and Excluding Bacteruria in the Emergency Department|
|Actual Study Start Date :||March 1, 2021|
|Estimated Primary Completion Date :||September 2021|
|Estimated Study Completion Date :||December 2021|
All patients admitted to the emergency department with suspected infections assessed by the receiving physician
Diagnostic Test: urine flow cytometry
Diagnostic test of urine flow cytometry. A urine sample will be collected according to routine procedure by a study assistant. The sample will be divided into two aliquots; half for routine urine culturing, and half for Point-of-care Urine Flow cytometry (POC-UFC) analysis (UF-5000, Sysmex, Kobe, Japan). The analysis will be performed according to manufacturer's instruction and conducted by laboratory staff. Laboratory staff will be blinded to the participants diagnosis and outcome. The results of the POC-UFC analysis will not be visible to the treating physician.
- Bacteriuria [ Time Frame: urine collected within 4 hours of arrival to emergency department and analysed within one week ]The urine culture analysis combined with microbiologist assessment will be used as reference standard for bacteriuria. Diagnostic accuracy will be conducted, and Youden index analysis will be used to estimate the best cut-off
- Verified infectious diagnosis by expert panel [ Time Frame: 2 months after discharge ]An expert panel will define the final diagnosis (including APN) based on all findings during admission. The expert panel consists of two independent consultants from the emergency department with significant experience in emergency medicine and acute infections. They will individually determine the type of infection the patient admitted actually had. The final diagnosis will be based on all available relevant information from the patient medical record including MRI of kidneys and HR-CT of lungs. A standardized template will be used. Disagreement will be discussed until a consensus is reached.
- Intensive care unit treatment [ Time Frame: within 60 days from admission to emergency department ]transfer to ICU during current admission (binary outcome)
- Length of stay [ Time Frame: within 60 days from admission to emergency department ]days spent in hospital during current admission
- The number of participants who died within 30 days [ Time Frame: within 30 days from arrival day ]binary - 30-days mortality
- The number of participants who died within 90 days [ Time Frame: within 90 days from arrival day ]binary - 90 days mortality
- Readmission [ Time Frame: within 30 days from day of discharge ]binary
- In-hospital mortality [ Time Frame: within 60 days from admission to emergency department ]binary
- Level of infection markers [ Time Frame: blood collected within 4 hours of arrival to emergency department ]Concentration of serum procalcitonin, CRP and suPAR
- Urological intervention [ Time Frame: Measured 7 days after admission ]Number of patients, who during the course of admission with suspected acute pyelonephritis requires urological interventions
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04686292
|Contact: Helene Skjøt-Arkil, PhD||_45 79971113||Helene.Skjoet-Arkil@rsyd.dk|
|Contact: Christian Backer Mogensen||+4579971123||Christian.Backer.Mogensen@rsyd.dk|
|Hospital of Southern Jutland||Recruiting|
|Contact: Christian B Mogensen, MD|
|Study Chair:||Christian Backer Mogensen||Hospital of Southern Jutland|