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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
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Suspected infection | All patients admitted to the emergency department with suspected infections assessed by the receiving physician |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| urine flow cytometry | Diagnostic Test | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Bacteriuria | 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 | urine collected within 4 hours of arrival to emergency department and analysed within one week |
| Measure | Description | Time Frame |
|---|---|---|
| Verified infectious diagnosis by expert panel | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Intensive care unit treatment | transfer to ICU during current admission (binary outcome) | within 60 days from admission to emergency department |
| Length of stay | days spent in hospital during current admission |
Inclusion Criteria:
Exclusion Criteria:
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Acutely admitted patients with suspected infections from three emergency departments (EDs) in the Region of Southern Denmark (Hospital Sønderjylland, Hospital Lillebælt, Odense University Hospital)
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| Name | Affiliation | Role |
|---|---|---|
| Christian Backer Mogensen | Hospital of Southern Jutland | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital of Southern Jutland | Aabenraa | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28754533 | Background | Koves B, Cai T, Veeratterapillay R, Pickard R, Seisen T, Lam TB, Yuan CY, Bruyere F, Wagenlehner F, Bartoletti R, Geerlings SE, Pilatz A, Pradere B, Hofmann F, Bonkat G, Wullt B. Benefits and Harms of Treatment of Asymptomatic Bacteriuria: A Systematic Review and Meta-analysis by the European Association of Urology Urological Infection Guidelines Panel. Eur Urol. 2017 Dec;72(6):865-868. doi: 10.1016/j.eururo.2017.07.014. Epub 2017 Jul 25. | |
| 29223137 |
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| ID | Term |
|---|---|
| D004630 | Emergencies |
| D014552 | Urinary Tract Infections |
| D004194 | Disease |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007239 | Infections |
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|
| 2 months after discharge |
| within 60 days from admission to emergency department |
| The number of participants who died within 30 days | binary - 30-days mortality | within 30 days from arrival day |
| The number of participants who died within 90 days | binary - 90 days mortality | within 90 days from arrival day |
| Readmission | binary | within 30 days from day of discharge |
| In-hospital mortality | binary | within 60 days from admission to emergency department |
| Level of infection markers | Concentration of serum procalcitonin, CRP and suPAR | blood collected within 4 hours of arrival to emergency department |
| Urological intervention | Number of patients, who during the course of admission with suspected acute pyelonephritis requires urological interventions | Measured 7 days after admission |
| Background |
| Herraez O, Asencio MA, Carranza R, Jarabo MM, Huertas M, Redondo O, Arias-Arias A, Jimenez-Alvarez S, Solis S, Zamarron P, Illescas MS, Galan MA. Sysmex UF-1000i flow cytometer to screen urinary tract infections: the URISCAM multicentre study. Lett Appl Microbiol. 2018 Mar;66(3):175-181. doi: 10.1111/lam.12832. Epub 2018 Jan 28. |
| 34593497 | Derived | Skjot-Arkil H, Heltborg A, Lorentzen MH, Cartuliares MB, Hertz MA, Graumann O, Rosenvinge FS, Petersen ERB, Ostergaard C, Laursen CB, Skovsted TA, Posth S, Chen M, Mogensen CB. Improved diagnostics of infectious diseases in emergency departments: a protocol of a multifaceted multicentre diagnostic study. BMJ Open. 2021 Sep 30;11(9):e049606. doi: 10.1136/bmjopen-2021-049606. |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |