Improved diagnostics of infectious diseases in emergency departments: a protocol of a multifaceted multicentre diagnostic study

Abstract

BackgroundThe major obstacle in prescribing an appropriate and targeted antibiotic treatment is insufficient knowledge concerning whether the patient has a bacterial infection, where the focus of infection is and which bacteria are the agents of the infection. A prerequisite for the appropriate use of antibiotics is timely access to accurate diagnostics such as point-of-care (POC) testing.The study aims to evaluate diagnostic tools and working methods that support a prompt and accurate diagnosis of hospitalised patients suspected of an acute infection. We will focus on the most common acute infections: community-acquired pneumonia (CAP) and acute pyelonephritis (APN). The objectives are to investigate (1) patient characteristics and treatment trajectory of the different acute infections, (2) diagnostic and prognostic accuracy of infection markers, (3) diagnostic accuracy of POC urine flow cytometry on diagnosing and excluding bacteriuria, (4) how effective the addition of POC analysis of sputum to the diagnostic set-up for CAP is on antibiotic prescriptions, (5) diagnostic accuracy of POC ultrasound and ultralow dose (ULD) computerized tomography (CT) on diagnosing CAP, (6) diagnostic accuracy of specialist ultrasound on diagnosing APN, (7) diagnostic accuracy of POC ultrasound in diagnosing hydronephrosis in patients suspected of APN.Methods and analysisIt is a multifaceted multicentre diagnostic study, including 1000 adults admitted with suspicion of an acute infection. Participants will, within the first 24 hours of admission, undergo additional diagnostic tests including infection markers, POC urine flow cytometry, POC analysis of sputum, POC and specialist ultrasound, and ULDCT. The primary reference standard is an assigned diagnosis determined by a panel of experts.Ethics, dissemination and registrationApproved by Regional Committees on Health Research Ethics for Southern Denmark, Danish Data Protection Agency and clinicaltrials.gov. Results will be presented in peer-reviewed journals, and positive, negative and inconclusive results will be published.Trial registration numbersNCT04661085, NCT04681963, NCT04667195, NCT04652167, NCT04686318, NCT04686292, NCT04651712, NCT04645030, NCT04651244.

The Diagnostic Accuracy of Procalcitonin, Soluble Urokinase-Type Plasminogen Activator Receptors, and C-Reactive Protein in Diagnosing Urinary Tract Infections in the Emergency Department—A Diagnostic Accuracy Study

“…This is a diagnostic accuracy type 1 multicentre study with prospective data collection, exploring the diagnostic capabilities of three index tests (PCT, suPAR, and CRP) and three reference tests (UTI diagnosis, UTI severity, and bacteremia). This study presents one of the objectives of the multifaceted INDEED (Infectious Diseases in Emergency Departments) study, which aims to develop new diagnostic tools and methods to facilitate rapid and accurate diagnoses, thus reducing the number of non-targeted antibiotic prescriptions in emergency departments [ 33 ].…”

“…Patients were eligible unless they were below 18 years of age, pregnant, had a severe immunodeficiency, had a prior admittance over 24 h within the last 14 days, tested positive for COVID-19 within the previous 14 days, or if participation would delay life-saving treatment [ 33 ].…”

“…Due to Danish data protection laws, data cannot be made available. The full study protocol is published and freely available [ 33 ]. The Supplemental Material is the STARD checklist, required for the STARD criteria.…”

Ultra-low-dose emergency chest computed tomography protocols in three vendors: A technical note

“…Further exclusion criteria can be found in a previous publication. 9 Patients who consented were referred for non-contrast chest CT (NCCT) using the local clinical chest CT protocol followed by an ULDCT. The scans were performed in the same sequence.…”

“…[5][6][7][8] The purpose of this technical note was to compare radiation dose and technical image quality using a standard dose and an ultra-low-dose chest CT protocol designed for a prospective clinical multicenter study entitled 'Improved diagnosis of infectious diseases in emergency departments'. 9…”