Clinical trial NCT04686292: Diagnostic Accuracy of Urine Flow Cytometry in Excluding Bacteruria
Official title: Diagnostic Accuracy of Urine Flow Cytometry in Diagnosing and Excluding Bacteruria in the Emergency Department
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Infection
Keywords: Emergency department
Acute infections
bacteruria
urinary tract infections
diagnosis
Lead sponsor: University of Southern Denmark
Sponsor class: OTHER
First posted: 2020-12-28
Enrollment: 966
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Acutely admitted patients with suspected infections from three emergency departments (EDs) in the Region of Southern Denmark (Hospital Sønderjylland, Hospital Lillebælt, Odense University Hospital)

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

Eligibility criteria: Inclusion Criteria:

* Suspicion of acute infections assessed by the receiving physician at the emergency department

Exclusion Criteria:

* If the attending physician considers that participation will delay a life-saving treatment or patient needs direct transfer to the intensive care unit.
* Admission within the last 14 days
* Verified COVID-19 disease within 14 days before admission
* Pregnant women
* Severe immunodeficiencies: Primary immunodeficiencies and secondary immunodeficiencies (HIV positive CD4 \<200, Patients receiving immunosuppressive treatment (ATC L04A), Corticosteroid treatment (\>20 mg/day prednisone or equivalent for \>14 days within the last 30 days), Chemotherapy within 30 days)

Primary outcomes:
measure: Bacteriuria
timeFrame: urine collected within 4 hours of arrival to emergency department and analysed within one week
Secondary outcomes:
measure: Verified infectious diagnosis by expert panel
timeFrame: 2 months after discharge
Other outcomes:
measure: Intensive care unit treatment
timeFrame: within 60 days from admission to emergency department
measure: Length of stay
timeFrame: within 60 days from admission to emergency department
measure: The number of participants who died within 30 days
timeFrame: within 30 days from arrival day
measure: The number of participants who died within 90 days
timeFrame: within 90 days from arrival day
measure: Readmission
timeFrame: within 30 days from day of discharge
measure: In-hospital mortality
timeFrame: within 60 days from admission to emergency department
measure: Level of infection markers
timeFrame: blood collected within 4 hours of arrival to emergency department
measure: Urological intervention
timeFrame: Measured 7 days after admission
Locations:
city: Aabenraa
country: Denmark
facility: Hospital of Southern Jutland
Study officials:
affiliation: Hospital of Southern Jutland
name: Christian Backer Mogensen
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.