Validation of Betalactam ML Prediction Models - TDMAide

Not Applicable

Not yet recruiting

• Conditions: Infections
• Interventions: Other: Daily short questionnaire; Device: Prediction of plasma concentration of piperacillin-tazobactam or meropenem; Diagnostic Test: Determination of plasma concentration of piperacillin-tazobactam or meropenem

• Registration Number: NCT06026852
• Lead Sponsor: University Hospital, Ghent

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-06-09
• Study First Submitted QC: 2023-09-04
• Study First Posted: 2023-09-07
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-05
• Last Update Posted: 2024-06-06
• Study Start: 2024-09-26
• Primary Completion: 2025-05-31
• Study Completion: 2025-05-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

• Admission to the ICU.
• Age above 18 years old.
• Treatment with piperacillin-tazobactam or meropenem for less than 48 hours.

Exclusion Criteria

• Pregnant or lactating patients.
• Limitation of therapy beyond "Do not resuscitate".
• Expected demise within 48 hours after inclusion.
• Haemoglobin < 7 g/dL.
• Previous inclusion in this study for a treatment course with the same antimicrobial.

Consultants and physicians in training

Inclusion Criteria:

• Consultant or physician in training working in the ICU.

Exclusion Criteria:

• None

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Physicians	Daily short questionnaire	Physicians in training or consultants who care for patients that are included in the study.
Patients	Determination of plasma concentration of piperacillin-tazobactam or meropenem	Patients admitted to the ICU who are treated with piperacillin-tazobactam or meropenem.
Patients	Prediction of plasma concentration of piperacillin-tazobactam or meropenem	Patients admitted to the ICU who are treated with piperacillin-tazobactam or meropenem.

Primary Outcome Measures

Name	Time	Method
Difference between predicted (TDMAIde) and measured (via HPLC-MS/MS method) plasma concentrations	Through study completion, an average of 1 year	The difference between the predicted concentration (from the TDMAide software) and the concentration range based on the measured concentration (measured from the blood sample from the patient and analyzed using a HPLC-MS/MS method, with and without taking into account intra- and inter measurement variabilities of the HPLC-MS/MS method.

Secondary Outcome Measures

Name	Time	Method
Perceived added value of therapeutic drug monitoring	Through study completion, an average of 1 year	The perceived added value of daily therapeutic drug monitoring from the responses to the survey
Perceived necessity of therapeutic drug monitoring	Through study completion, an average of 1 year	The perceived necessity of therapeutic drug monitoring of consultants and physicians in training working in the ICU by evaluating the perceived necessity collected during the surveys with the measured plasma concentrations.
Plasma concentration (determined via HPLC-MS/MS) trends	Through study completion, an average of 1 year	Trends in total plasma concentration over time of piperacillin-tazobactam and meropenem in patients admitted to the ICU
Correlation between plasma concentrations (measured by HPLC-MS/MS) and side effects as percentage of patients experiencing the side effect	Through study completion, an average of 1 year	The correlation between plasma concentrations of piperacillin-tazobactam and meropenem and the development of renal (decline in urinary output, rise in serum creatinin), gastro-intestinal (C. difficile infections, stool consistency, elevation of ALT/AST/gamma GT/Alkalic fosfatase/INR/APTT/bilirubin), neurological (delirium as measured by Intensice Care Delirium Screening Checklist - ICDSC) or hematological (Rise or fall of thrombocytes, development of leucopenia/agranulocytosis/eosinophelia/hemolytic anemia) side effects.

Trial Locations

Locations (1)

University Hospital, Ghent; 🇧🇪 Ghent, Belgium