Validation of Betalactam ML Prediction Models - TDMAide

NCT ID: NCT06026852

Last Updated: 2024-06-06

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 600 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-26
• Study Completion Date: 2025-05-31

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Patients

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

Group Type: OTHER

Prediction of plasma concentration of piperacillin-tazobactam or meropenem

Intervention Type: 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.

Determination of plasma concentration of piperacillin-tazobactam or meropenem

Intervention Type: 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.

Physicians

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

Group Type: OTHER

Daily short questionnaire

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

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.

Intervention Type: DIAGNOSTIC_TEST

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

• Consultant or physician in training working in the ICU.

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

• None

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Research Foundation Flanders

OTHER

Sponsor Role: collaborator

Imec

INDUSTRY

Sponsor Role: collaborator

University Hospital, Ghent

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jan De Waele, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Ghent

Locations

University Hospital, Ghent

Ghent, , Belgium

Countries

Belgium

Central Contacts

Thomas De Corte, MD

Role: CONTACT

thomas.decorte@uzgent.be

0032093324134

Facility Contacts

Jan De Waele, MD, PhD

Role: primary

Other Identifiers

CIV-23-04-042892

Identifier Type: -

Identifier Source: org_study_id