Clinical trial NCT06026852: Validation of Betalactam ML Prediction Models - TDMAide
Official title: Validation of Uncertainty Quantifying Machine Learning Models to Predict Beta-lactam Antimicrobial Concentrations in ICU Patients
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Infections
Keywords: Artificial Intelligence
Machine Learning
PK/PD
Piperacillin-tazobactam
Meropenem
Intensive Care Unit
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
Collaborators: name: Research Foundation Flanders
name: Imec
First posted: 2023-09-07
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Patients

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

Primary outcomes:
measure: Difference between predicted (TDMAIde) and measured (via HPLC-MS/MS method) plasma concentrations
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
measure: Plasma concentration (determined via HPLC-MS/MS) trends
timeFrame: Through study completion, an average of 1 year
measure: Correlation between plasma concentrations (measured by HPLC-MS/MS) and side effects as percentage of patients experiencing the side effect
timeFrame: Through study completion, an average of 1 year
measure: Perceived necessity of therapeutic drug monitoring
timeFrame: Through study completion, an average of 1 year
measure: Perceived added value of therapeutic drug monitoring
timeFrame: Through study completion, an average of 1 year
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: University Hospital, Ghent
Study officials:
affiliation: University Hospital, Ghent
name: Jan De Waele, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: