Ignite Creation Date:
2025-12-24 @ 3:54 PM
Ignite Modification Date:
2026-02-22 @ 6:45 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:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004630', 'term': 'Emergencies'}, {'id': 'D014552', 'term': 'Urinary Tract Infections'}, {'id': 'D004194', 'term': 'Disease'}], 'ancestors': [{'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 966}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2022-06-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-09-13', 'studyFirstSubmitDate': '2020-12-22', 'studyFirstSubmitQcDate': '2020-12-22', 'lastUpdatePostDateStruct': {'date': '2022-09-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-02-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Intensive care unit treatment', 'timeFrame': 'within 60 days from admission to emergency department', 'description': 'transfer to ICU during current admission (binary outcome)'}, {'measure': 'Length of stay', 'timeFrame': 'within 60 days from admission to emergency department', 'description': 'days spent in hospital during current admission'}, {'measure': 'The number of participants who died within 30 days', 'timeFrame': 'within 30 days from arrival day', 'description': 'binary - 30-days mortality'}, {'measure': 'The number of participants who died within 90 days', 'timeFrame': 'within 90 days from arrival day', 'description': 'binary - 90 days mortality'}, {'measure': 'Readmission', 'timeFrame': 'within 30 days from day of discharge', 'description': 'binary'}, {'measure': 'In-hospital mortality', 'timeFrame': 'within 60 days from admission to emergency department', 'description': 'binary'}, {'measure': 'Level of infection markers', 'timeFrame': 'blood collected within 4 hours of arrival to emergency department', 'description': 'Concentration of serum procalcitonin, CRP and suPAR'}, {'measure': 'Urological intervention', 'timeFrame': 'Measured 7 days after admission', 'description': 'Number of patients, who during the course of admission with suspected acute pyelonephritis requires urological interventions'}], 'primaryOutcomes': [{'measure': 'Bacteriuria', 'timeFrame': 'urine collected within 4 hours of arrival to emergency department and analysed within one week', 'description': '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'}], 'secondaryOutcomes': [{'measure': 'Verified infectious diagnosis by expert panel', 'timeFrame': '2 months after discharge', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Emergency department', 'Acute infections', 'bacteruria', 'urinary tract infections', 'diagnosis'], 'conditions': ['Acute Infection']}, 'referencesModule': {'references': [{'pmid': '28754533', 'type': 'BACKGROUND', '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.'}, {'pmid': '29223137', 'type': 'BACKGROUND', '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.'}, {'pmid': '34593497', 'type': 'DERIVED', '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.'}]}, 'descriptionModule': {'briefSummary': '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', 'detailedDescription': '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.\n\nThe 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.\n\nUnfortunately, 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.\n\nThe 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'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Acutely admitted patients with suspected infections from three emergency departments (EDs) in the Region of Southern Denmark (Hospital Sønderjylland, Hospital Lillebælt, Odense University Hospital)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Suspicion of acute infections assessed by the receiving physician at the emergency department\n\nExclusion Criteria:\n\n* If the attending physician considers that participation will delay a life-saving treatment or patient needs direct transfer to the intensive care unit.\n* Admission within the last 14 days\n* Verified COVID-19 disease within 14 days before admission\n* Pregnant women\n* 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)'}, 'identificationModule': {'nctId': 'NCT04686292', 'briefTitle': 'Diagnostic Accuracy of Urine Flow Cytometry in Excluding Bacteruria', 'organization': {'class': 'OTHER', 'fullName': 'University of Southern Denmark'}, 'officialTitle': 'Diagnostic Accuracy of Urine Flow Cytometry in Diagnosing and Excluding Bacteruria in the Emergency Department', 'orgStudyIdInfo': {'id': 'SHS-ED-12b-2020'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Suspected infection', 'description': 'All patients admitted to the emergency department with suspected infections assessed by the receiving physician', 'interventionNames': ['Diagnostic Test: urine flow cytometry']}], 'interventions': [{'name': 'urine flow cytometry', 'type': 'DIAGNOSTIC_TEST', 'description': "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.", 'armGroupLabels': ['Suspected infection']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Aabenraa', 'country': 'Denmark', 'facility': 'Hospital of Southern Jutland', 'geoPoint': {'lat': 55.04434, 'lon': 9.41741}}], 'overallOfficials': [{'name': 'Christian Backer Mogensen', 'role': 'STUDY_CHAIR', 'affiliation': 'Hospital of Southern Jutland'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Southern Denmark', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}