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NCT Number: NCT06163781

Appropriate Use of Blood Cultures in the Emergency Department Through Machine Learning

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Amsterdam UMC - location AMC

Amsterdam, Netherlands

Location status: Recruiting

Location contact

Prabath Nanayakkara, MD, PhD

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age >= 18 years
  • Have a clinical indication for a blood culture analysis (according to the treating physician)
  • Have sufficient data recorded (laboratory results and vital sign measurements) for a prediction to be made (at least 20% of the needed parameters)

Exclusion criteria

  • Central Venous Line (CVL) or Peripherally Inserted Central Catheter (PICC) in situ
  • Neutrophil count < 0.5 * 109/L
  • Candidemia or S. aureus bacteraemia in the past 3 months.
  • Most likely diagnosis of endocarditis/spondylodiscitis/infected prosthetic material
  • Pregnant or breastfeeding patients
  • Not capable of giving informed consent

Treatment and study plan

Blood culture prediction tool

Device

Machine learning based predicition tool

Primary outcomes

  1. 30-day mortality

    Time frame: 30 days

Secondary outcomes

  1. hospital admission rates

    Time frame: 1 day

  2. in-hospital mortality

    Time frame: 90 days

  3. hospital length-of-stay

    Time frame: 90 days

Other outcomes

  1. 30-day readmission rates

    Time frame: 30 days

  2. Length of stay in the ED in hours

    Time frame: 2 days

  3. Percentage of blood cultures avoided in the intervention group

    Time frame: 90 days

  4. 90 day mortality

    Time frame: 90 days

  5. Number of blood cultures on each day of hospital stay (in admitted patients)

    Time frame: 90 days

  6. Percentage of positive blood cultures in each group

    Time frame: 90 days

  7. Total number of laboratory- and microbiology tests in the ED

    Time frame: 2 days

  8. Total number of laboratory- and microbiology test on each day of hospital stay (in admitted patients)

    Time frame: 90 days

  9. Percentage of patients receiving antibiotics in the ED

    Time frame: 2 days

  10. Duration of antibiotic therapy

    Time frame: 90 days

  11. Types of antibiotics given in the ED

    Time frame: 2 days

  12. Model performance (AUC) during the trial

    Time frame: 3 years

  13. Model performance in subgroup of Immunocompromised patients (triple immunosuppressive therapy)

    Time frame: 3 years

  14. Model performance in subgroup of transplanted patients

    Time frame: 3 years

Study contacts

Contact information is provided by the study sponsor or research team.

Prabath WB Nanayakkara, MD, PhD

CONTACT

[email protected]

+31204444444

Sheena C Bhagirath, MD

CONTACT

[email protected]

+31204444444

Sponsors and collaborators

Lead sponsor

Amsterdam UMC, location VUmc

Other

Registry information

Official study title

Appropriate Use of Blood Cultures in the Emergency Department Through Machine Learning: a Randomized Controlled Trial

Acronym: ABC

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Dec 11, 2023
Registry last updated
May 7, 2024

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.

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