NCT06026852

Validation of Betalactam ML Prediction Models - TDMAide

Validation of Uncertainty Quantifying Machine Learning Models to Predict Beta-lactam Antimicrobial Concentrations in ICU Patients

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 600 (estimated)
• Sponsor: University Hospital, Ghent · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Accepted

Summary

The goal of this study is to learn about the real wold behavior of developed machine learning models that predict the plasma concentration of piperacillin-tazobactam and meropenem in critically ill patients admitted to the intensive care unit (ICU). The main aim of the study is to validate the performance of these machine learning models. To this end, daily measured plasma concentrations of the investigated antimicrobials will be compared with the predicted concentration by the machine learning algorithms. Additional goals of the study include: * To describe the total plasma concentration over time of piperacillin-tazobactam and meropenem in patients admitted to the ICU. * To quantify the correlation between plasma concentrations of piperacillin-tazobactam and meropenem and the development of side effects. * To evaluate the perceived necessity of therapeutic drug monitoring (TDM) of consultants and physicians in training working in the ICU. * To evaluate the perceived added value of daily TDM. Samples (where possible taken routinely) from participating patients will be analyzed for meropenem and piperacillin-tazobactam plasma concentration. Participating physicians will be asked to fill in a short daily questionnaire during the time a patient under their care is treated with the antimicrobial under investigation.

Conditions

• Infections

Interventions

Type	Name	Description
DEVICE	Prediction of plasma concentration of piperacillin-tazobactam or meropenem	For included patients, a prediction will be made by developed machine learning models about the expected plasma concentration of piperacillin-tazobactam or meropenem by using routinely collected health care data.
DIAGNOSTIC_TEST	Determination of plasma concentration of piperacillin-tazobactam or meropenem	For included patients, the total plasma concentration of piperacillin-tazobactam or meropenem will be determined. Were possible, this will be done using a blood sample that was collected during routine daily bloodwork which is performed in the morning. If no routine sample is available, a study specific sample will be drawn at approximately the same time as a routine sample would be drawn.
OTHER	Daily short questionnaire	Physicians who care for patients included in the study will be asked to fill in a short daily questionnaire that evaluates the perceived necessity and added value of daily therapeutic drug monitoring.

Timeline

• Start date: 2024-09-26
• Primary completion: 2025-05-31
• Completion: 2025-05-31
• First posted: 2023-09-07
• Last updated: 2024-06-06

Locations

1 site across 1 country: Belgium