InfectionsTDMAideNCT06026852
Validation of Betalactam ML Prediction Models - TDMAide
A study testing Prediction of plasma concentration of piperacillin-tazobactam or meropenem, Determination of plasma concentration of piperacillin-tazobactam or meropenem and Daily short questionnaire in people with Infections, run by University Hospital, Ghent at 1 site in Belgium.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Infections
- What is being tested?
- Prediction of plasma concentration of piperacillin-tazobactam or meropenem, Determination of plasma concentration of piperacillin-tazobactam or meropenem and Daily short questionnaire
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteBelgium
- Study dates
- 26 Sep 2024to 31 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Belgium1 site
University Hospital, Ghent
Ghent, 9000
Jan De Waele, MD, PhD
Jan De Waele, MD, PhD
About this study
Official title: Validation of Uncertainty Quantifying Machine Learning Models to Predict Beta-lactam Antimicrobial Concentrations in ICU Patients
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.
Read more
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
- Being tested
- Prediction of plasma concentration of piperacillin-tazobactam or meropenem, Determination of plasma concentration of piperacillin-tazobactam or meropenem, Daily short questionnaire
- Keywords
- Artificial Intelligence, Machine Learning, PK/PD, Piperacillin-tazobactam, Meropenem, Intensive Care Unit
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prediction of plasma concentration of piperacillin-tazobactam or meropenemDevice
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 meropenemDiagnostic 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.
Daily short questionnaireOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients | Other | Patients admitted to the ICU who are treated with piperacillin-tazobactam or meropenem. Receives: 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. Receives: Other: Daily short questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Through study completion, an average of 1 year
Secondary outcomes (4)
Plasma concentration (determined via HPLC-MS/MS) trends
Trends in total plasma concentration over time of piperacillin-tazobactam and meropenem in patients admitted to the ICU
Measured: 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
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.
Measured: Through study completion, an average of 1 year
Perceived necessity of therapeutic drug monitoring
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.
Measured: Through study completion, an average of 1 year
Perceived added value of therapeutic drug monitoring
The perceived added value of daily therapeutic drug monitoring from the responses to the survey
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2023
- Study start26 Sep 2024 (estimated)
- Primary completion31 May 2025 (estimated)
- Study completion31 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfectionsStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- Research Foundation Flanders, Imec
- Responsible party
- Sponsor
- Investigators
- Jan De Waele, MD, PhD, Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06026852
- Sponsor's protocol ID
- CIV-23-04-042892
- Acronym
- TDMAide
- Status last verified
- Jun 2024
- First submitted
- 9 Jun 2023
- Last updated
- 6 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data will be made available upon reasonable request and after approval by the appropriate ethical and regulatory bodies.
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Uncertainty Quantifying Machine Learning Models to Predict Beta-lactam Antimicrobial Concentrations in ICU Patients
- ClinicalTrials.gov ID
- NCT06026852
- Acronym / sponsor ID
- TDMAide / CIV-23-04-042892
- Conditions
- Infections
- Keywords
- Artificial Intelligence, Machine Learning, PK/PD, Piperacillin-tazobactam, Meropenem, Intensive Care Unit
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Collaborators
- Research Foundation Flanders, Imec
- Study start
- 26 Sep 2024 (estimated)
- Primary completion
- 31 May 2025 (estimated)
- Study completion
- 31 May 2025 (estimated)
- First posted
- 7 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients | Other | Device: Prediction of plasma concentration of piperacillin-tazobactam or meropenem, Diagnostic Test: Determination of plasma concentration of piperacillin-tazobactam or meropenemPatients admitted to the ICU who are treated with piperacillin-tazobactam or meropenem. |
| Physicians | Other | Other: Daily short questionnairePhysicians in training or consultants who care for patients that are included in the study. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prediction of plasma concentration of piperacillin-tazobactam or meropenemFor 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. | Device | Patients |
| Determination of plasma concentration of piperacillin-tazobactam or meropenemFor 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. | Diagnostic test | Patients |
| Daily short questionnairePhysicians 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. | Other | Physicians |
Primary outcome
Difference between predicted (TDMAIde) and measured (via HPLC-MS/MS method) plasma concentrations
Time frame: 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.
4 secondary outcomes
Plasma concentration (determined via HPLC-MS/MS) trends
Time frame: 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
Time frame: Through study completion, an average of 1 year
Perceived necessity of therapeutic drug monitoring
Time frame: Through study completion, an average of 1 year
Perceived added value of therapeutic drug monitoring
Time frame: Through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2024.
- Individual participant dataSharing planned: Yes. Individual participant data will be made available upon reasonable request and after approval by the appropriate ethical and regulatory bodies.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jan De Waele, MD, PhD principal investigator
University Hospital, Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prediction of plasma concentration of piperacillin-tazobactam or meropenem, Determination of plasma concentration of piperacillin-tazobactam or meropenem and Daily short questionnaire in people with Infections, run by University Hospital, Ghent at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Thomas De Corte, MD (0032093324134, thomas.decorte@uzgent.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference between predicted (TDMAIde) and measured (via HPLC-MS/MS method) plasma concentrations (time frame: Through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2024.