Model Informed Precision DosingNCT07315438
Model-Informed Precision Dosing on Amikacin and Vancomycin Therapy in Critically Ill Children
A study testing MIPD Tool in people with Model Informed Precision Dosing, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
Achieving optimal antibiotic exposure in critically ill pediatric patients is difficult due to (their) dynamic physiology and variability. Conventional weight-based regimens often fail to reach pharmacokinetic/pharmacodynamic (PK/PD) targets for narrow therapeutic index agents such as vancomycin and amikacin. Read more about this study
- Who is it for?
- Ages 38 to 81 months
- Conditions the study is for
- Model Informed Precision Dosing
- What is being tested?
- MIPD Tool
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2023to 27 Oct 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 38 to 81 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Hospitalized patients (NICU) receiving vancomycin or amikacin
- Treatment with vancomycin or amikacin initiated during hospitalization
- At least one therapeutic drug monitoring (TDM) measurement obtained Exclusion Criteria
- Failure to obtain written informed consent
- Death within the first 24 hours after treatment initiation
- Discontinuation of therapy before the first TDM measurement
- Determined unsuitable for study participation by the treating physician
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Model-Informed Precision Dosing on Amikacin and Vancomycin Therapy in Critically Ill Children: A Pilot Randomized Clinical Trial
Achieving optimal antibiotic exposure in critically ill pediatric patients is difficult due to (their) dynamic physiology and variability. Conventional weight-based regimens often fail to reach pharmacokinetic/pharmacodynamic (PK/PD) targets for narrow therapeutic index agents such as vancomycin and amikacin. Model-Informed Precision Dosing (MIPD), which integrates Bayesian forecasting with population pharmacokinetics (popPK), offers a potentially valuable yet underexplored approach in pediatric intensive care to better attain and sustain target exposure. This pilot randomized clinical trial evaluated MIPD-guided dosing of vancomycin and amikacin using InsightRX Nova® versus standard of care (SoC) in a tertiary PICU. Patients whose model-recommended doses matched standard regimens were analyzed under SoC. Primary outcomes included prediction accuracy (a priori vs a posteriori) and model fit; secondary outcomes assessed dose optimization, inflammatory response, renal safety, treatment duration, and mortality.
- Conditions
- Model Informed Precision Dosing
- Being tested
- MIPD Tool
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MIPD ToolDevice
It is a precision dosing platform that combines population pharmacokinetic/pharmacodynamic (popPK/PD) modeling with artificial intelligence and machine learning to optimize individualized drug therapy.
It uses patient-specific demographic, clinical, and laboratory data to generate real-time personalized dosing recommendations based on validated popPK models.
| Study group | Role | What they receive |
|---|---|---|
| MIPD Group | Experimental | Not described Receives: Device: MIPD Tool |
| Standard of Care Group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Predictive Accuracy of Model-Informed Precision Dosing (MIPD) Based on Median Absolute Error (MdAE)
Predictive accuracy of the pharmacokinetic model will be evaluated by calculating the Median Absolute Error (MdAE) between model-predicted and observed antibiotic serum concentrations. MdAE was prespecified as the primary accuracy metric due to its robustness to outliers in small pediatric samples.
Measured: From first therapeutic drug monitoring (TDM) sample to second TDM sample (typically within 3-5 days of therapy)
Predictive Accuracy of Model-Informed Precision Dosing (MIPD) Based on Mean Absolute Error (MAE)
Mean Absolute Error (MAE) between model-predicted and observed serum antibiotic concentrations will be calculated to assess overall prediction error.
Measured: From first therapeutic drug monitoring (TDM) sample to second TDM sample (typically within 3-5 days of therapy)
Predictive Accuracy of Model-Informed Precision Dosing (MIPD) Based on Median Error (MdE)
Median Error (MdE) will be calculated to evaluate directional bias between predicted and observed serum antibiotic concentrations.
Measured: From first therapeutic drug monitoring (TDM) sample to second TDM sample (typically within 3-5 days of therapy)
Secondary outcomes (4)
Change in C-Reactive Protein (CRP) Level
The absolute change in serum C-reactive protein (CRP) level from baseline (within 24 hours of antibiotic initiation) to the time of the second TDM sample will be evaluated as an inflammatory response marker.
Measured: Baseline to approximately day 3-5 of therapy
Change in Procalcitonin Level
The absolute change in serum procalcitonin level from baseline to the time of the second TDM sample will be assessed.
Measured: Baseline to approximately day 3-5 of therapy
Change in Serum Creatinine Level
The absolute change in serum creatinine level from baseline to the time of the second TDM sample will be evaluated as a marker of renal safety.
Measured: Baseline to approximately day 3-5 of therapy
Change in Pharmacokinetic Model-Fit Category
Within-patient change in pharmacokinetic model-fit category (poor, intermediate, good) between the first and second TDM measurements will be assessed to evaluate improvement in model performance after Bayesian updating.
Measured: From first to second TDM sample (typically within 3-5 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2026
- Study start1 Dec 2023
- Primary completion30 Aug 2025
- Study completion27 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Model Informed Precision DosingStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nadir Yalçın, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07315438
- Sponsor's protocol ID
- Neo-MIPD
- Status last verified
- Nov 2025
- First submitted
- 28 Nov 2025
- Last updated
- 2 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bayraktar I, Kasikci M, Benek Z, Allegaert K, Egehan Oruncu B, Kesici S, Bayrakci B, Yalcin N. A prospective feasibility study evaluating the implementation of model-informed precision dosing in critically ill children. Front Pharmacol. 2026 Feb 3;17:1733291. doi: 10.3389/fphar.2026.1733291. eCollection 2026.
PubMed 41710930
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Model-Informed Precision Dosing on Amikacin and Vancomycin Therapy in Critically Ill Children: A Pilot Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07315438
- Acronym / sponsor ID
- Neo-MIPD
- Conditions
- Model Informed Precision Dosing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 30 Aug 2025 (actual)
- Study completion
- 27 Oct 2025 (actual)
- First posted
- 2 Jan 2026 (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.
Achieving optimal antibiotic exposure in critically ill pediatric patients is difficult due to (their) dynamic physiology and variability. Conventional weight-based regimens often fail to reach pharmacokinetic/pharmacodynamic (PK/PD) targets for narrow therapeutic index agents such as vancomycin and amikacin. Model-Informed Precision Dosing (MIPD), which integrates Bayesian forecasting with population pharmacokinetics (popPK), offers a potentially valuable yet underexplored approach in pediatric intensive care to better attain and sustain target exposure. This pilot randomized clinical trial evaluated MIPD-guided dosing of vancomycin and amikacin using InsightRX Nova® versus standard of care (SoC) in a tertiary PICU. Patients whose model-recommended doses matched standard regimens were analyzed under SoC. Primary outcomes included prediction accuracy (a priori vs a posteriori) and model fit; secondary outcomes assessed dose optimization, inflammatory response, renal safety, treatment duration, and mortality.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MIPD Group | Experimental | Device: MIPD Tool |
| Standard of Care Group | No intervention | – |
Who may qualify
- Ages
- 38 to 81 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Hospitalized patients (NICU) receiving vancomycin or amikacin
- Treatment with vancomycin or amikacin initiated during hospitalization
- At least one therapeutic drug monitoring (TDM) measurement obtained Exclusion Criteria
- Failure to obtain written informed consent
- Death within the first 24 hours after treatment initiation
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| MIPD ToolIt is a precision dosing platform that combines population pharmacokinetic/pharmacodynamic (popPK/PD) modeling with artificial intelligence and machine learning to optimize individualized drug therapy. It uses patient-specific demographic, clinical, and laboratory data to generate real-time personalized dosing recommendations based on validated popPK models. | Device | MIPD Group |
Primary outcome
Predictive Accuracy of Model-Informed Precision Dosing (MIPD) Based on Median Absolute Error (MdAE)
Time frame: From first therapeutic drug monitoring (TDM) sample to second TDM sample (typically within 3-5 days of therapy)
Predictive accuracy of the pharmacokinetic model will be evaluated by calculating the Median Absolute Error (MdAE) between model-predicted and observed antibiotic serum concentrations. MdAE was prespecified as the primary accuracy metric due to its robustness to outliers in small pediatric samples.
Predictive Accuracy of Model-Informed Precision Dosing (MIPD) Based on Mean Absolute Error (MAE)
Time frame: From first therapeutic drug monitoring (TDM) sample to second TDM sample (typically within 3-5 days of therapy)
Mean Absolute Error (MAE) between model-predicted and observed serum antibiotic concentrations will be calculated to assess overall prediction error.
Predictive Accuracy of Model-Informed Precision Dosing (MIPD) Based on Median Error (MdE)
Time frame: From first therapeutic drug monitoring (TDM) sample to second TDM sample (typically within 3-5 days of therapy)
Median Error (MdE) will be calculated to evaluate directional bias between predicted and observed serum antibiotic concentrations.
4 secondary outcomes
Change in C-Reactive Protein (CRP) Level
Time frame: Baseline to approximately day 3-5 of therapy
Change in Procalcitonin Level
Time frame: Baseline to approximately day 3-5 of therapy
Change in Serum Creatinine Level
Time frame: Baseline to approximately day 3-5 of therapy
Change in Pharmacokinetic Model-Fit Category
Time frame: From first to second TDM sample (typically within 3-5 days)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2026.
- Derived from this study: PubMed 41710930Bayraktar I, Kasikci M, Benek Z, Allegaert K, Egehan Oruncu B, Kesici S, Bayrakci B, Yalcin N. A prospective feasibility study evaluating the implementation of model-informed precision dosing in critically ill children. Front Pharmacol. 2026 Feb 3;17:1733291. doi: 10.3389/fphar.2026.1733291. eCollection 2026.
- Individual participant dataSharing planned: No
Related trials for Model Informed Precision Dosing
RecruitingPhase 4
Precision Dosing of Beta-lactam Antibiotics in Critically Ill Children
Amoxicillin-clavulanate, Piperacillin-tazobactam
Not yet recruitingObservational study
A Predictive Model for Postoperative Analgesic Requirements After Abdominal Surgery
Postoperative Pain, Postoperative Analgesia
Not yet recruitingObservational study
Model-Informed Precision Dosing on Cyclosporine Therapy in Hematopoietic Stem Cell Transplant Recipients
Bone Marrow Transplantation, AML
Not yet recruitingObservational study
Model-Informed Precision Dosing of Tacrolimus in Pediatric Kidney Transplantation
Pediatric Kidney Transplantation
RecruitingObservational study
DoseTB-individualised Dosing by Model-informed Precision Dosing for Pulmonary Tuberculosis
Tuberculosis, Pulmonary
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MIPD Tool in people with Model Informed Precision Dosing, run by Hacettepe University at 1 site in Turkey (Türkiye).
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 7 inclusion and 0 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: finished, as of the sponsor's last update on 2 Jan 2026. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Predictive Accuracy of Model-Informed Precision Dosing (MIPD) Based on Median Absolute Error (MdAE) (time frame: From first therapeutic drug monitoring (TDM) sample to second TDM sample (typically within 3-5 days of therapy)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07315438, which also lists 1 linked publication.
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 2 Jan 2026.