Amsterdam UMC - location AMC
Amsterdam, Netherlands
Location status: Recruiting
Location contact
Prabath Nanayakkara, MD, PhD
CONTACT
NCT Number: NCT06163781
The goal of this clinical trial is to study whether the use of our blood culture prediction tool is non-inferior to current practice and if it can improve certain outcomes in all adult patients presenting to the emergency department with a clinical indication for a blood culture analysis (according to the treating physician). The primary endpoint is 30-day mortality. Key secondary outcomes are:
* hospital admission rates * in-hospital mortality * hospital length-of-stay. In the intervention group, the physician will follow the advice of our blood culture prediction tool.
In the comparison group all patients will undergo a blood culture analysis.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Amsterdam, Netherlands
Location status: Recruiting
Prabath Nanayakkara, MD, PhD
CONTACT
Rationale: The overuse of blood cultures in emergency departments leads to low yields and high numbers of contaminated cultures, which is associated with increased diagnostics, antibiotic usage, prolonged hospitalisation, and mortality. Ideally, blood cultures would only be performed in patients with a high risk for a positive culture. The investigators have developed a machine learning model to predict the outcome of blood cultures in the ED. Retrospective and prospective validation of the tool in various settings show that it can be used to reduce the number of blood culture analyses by at least 30% and help avoid the hidden costs of contaminated cultures.
Objective: This study aims to investigate whether the use of our blood culture prediction tool is non-inferior to current practice and if it can improve certain outcomes.
Study design: A randomized controlled non-inferiority trial. Study population: All adult patients presenting to the emergency department with a clinical indication for a blood culture analysis (according to the treating physician).
Intervention: In the control group, all patients will undergo a blood culture analysis. In the intervention group, the physician will follow the advice of our blood culture prediction tool. If the chance of a positive blood culture is < 5%, the blood culture analysis will be cancelled and the sample destroyed. If the change of a positive blood culture is > 5%, the blood culture analysis will be performed as usual.
Main study parameters/endpoints: The primary endpoint is 30-day mortality, for which the investigators aim to show non-inferiority. Key secondary outcomes, for which the investigators also aim to show non-inferiority, are hospital admission rates, in-hospital mortality, and hospital length-of-stay.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Machine learning based predicition tool
Time frame: 30 days
Time frame: 1 day
Time frame: 90 days
Time frame: 90 days
Time frame: 30 days
Time frame: 2 days
Time frame: 90 days
Time frame: 90 days
Time frame: 90 days
Time frame: 90 days
Time frame: 2 days
Time frame: 90 days
Time frame: 2 days
Time frame: 90 days
Time frame: 2 days
Time frame: 3 years
Time frame: 3 years
Time frame: 3 years
Contact information is provided by the study sponsor or research team.
Prabath WB Nanayakkara, MD, PhD
CONTACT
Sheena C Bhagirath, MD
CONTACT
Amsterdam UMC, location VUmc
Other
Appropriate Use of Blood Cultures in the Emergency Department Through Machine Learning: a Randomized Controlled Trial
Acronym: ABC
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT05176769
Artificial Intelligence, Electronic Medical Records
Alexandroupoli, Greece
View Trial DetailsNCT07312019
Artificial Intelligence, Clinical Decision Support
Amiens, France
View Trial DetailsNCT05352399
Artificial Intelligence, Brain Diseases
New Haven, Connecticut, United States
View Trial DetailsNCT05984082
Artificial Intelligence, Diagnostic Imaging
Philadelphia, Pennsylvania, United States
View Trial Details