Validation of Betalactam ML Prediction Models - TDMAide

NCT06026852 | Not Yet Recruiting DMC

• 1 other identifier: CIV-23-04-042892
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

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.

Conditions

Infections

Keywords

Artificial Intelligence; Machine Learning; PK/PD; Piperacillin-tazobactam; Meropenem; Intensive Care Unit

Outcome Measures

Primary Outcomes (1)

• Difference between predicted (TDMAIde) and measured (via HPLC-MS/MS method) plasma concentrations

  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.

  Through study completion, an average of 1 year

Secondary Outcomes (4)

• Plasma concentration (determined via HPLC-MS/MS) trends

  Through study completion, an average of 1 year

• 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

• Perceived necessity of therapeutic drug monitoring

  Through study completion, an average of 1 year

• Perceived added value of therapeutic drug monitoring

  Through study completion, an average of 1 year

Study Arms (2)

Patients

OTHER

Patients admitted to the ICU who are treated with piperacillin-tazobactam or meropenem.

Device: Prediction of plasma concentration of piperacillin-tazobactam or meropenem; Diagnostic Test: Determination of plasma concentration of piperacillin-tazobactam or meropenem

Physicians

OTHER

Physicians in training or consultants who care for patients that are included in the study.

Other: Daily short questionnaire

Interventions

Prediction of plasma concentration of piperacillin-tazobactam or meropenem DEVICE

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.

Patients

Determination of plasma concentration of piperacillin-tazobactam or meropenem DIAGNOSTIC_TEST

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.

Patients

Daily short questionnaire OTHER

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.

Physicians

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Pregnant or lactating patients.
• Limitation of therapy beyond "Do not resuscitate".
• Haemoglobin \< 7 g/dL.
• Consultants and physicians in training
• Consultant or physician in training working in the ICU.
• None

Sponsors & Collaborators

• University Hospital, Ghent: lead
• Research Foundation Flanders: collaborator
• Imec: collaborator

Study Sites (1)

University Hospital, Ghent

Ghent, 9000, Belgium

Location

MeSH Terms

Conditions

Infections

Study Officials

• Jan De Waele, MD, PhD

  University Hospital, Ghent

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Thomas De Corte, MD

CONTACT

0032093324134; thomas.decorte@uzgent.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2023
• First Posted: September 7, 2023
• Study Start: September 26, 2024
• Primary Completion: May 31, 2025
• Study Completion: May 31, 2025
• Last Updated: June 6, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ICF, CSR, ANALYTIC CODE
• Time Frame: At publication of the results
• Access Criteria: Individual participant data will be made available upon reasonable request and after approval by the appropriate ethical and regulatory bodies.

Locations

BE (1)