Amoxicillin-clavulanatePhase 4MOMENTUMNCT06929702
Precision Dosing of Beta-lactam Antibiotics in Critically Ill Children
A Phase 4 study testing Beta-lactam antibiotic and Beta-lactam model-informed precision dosing in people with Amoxicillin-clavulanate and Piperacillin-tazobactam, run by University Hospital, Ghent at 1 site in Belgium.
Trial summary
The overall objective of this study is to investigate the impact of early model-informed precision dosing (MIPD) on target attainment of three beta-lactam antibiotics (amoxicillin-clavulanic acid, piperacillin-tazobactam and meropenem) in critically ill children. Read more about this study
- Who is it for?
- Ages 0 to 18 years
- Conditions the study is for
- Amoxicillin-clavulanate, Piperacillin-tazobactam, Meropenem
- What is being tested?
- Beta-lactam antibiotic and Beta-lactam model-informed precision dosing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteBelgium
- Study dates
- 9 Jul 2025to 1 Oct 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 0 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Subject aged between 0 - 17 years 10 months.
- Subject admitted to a participating ward unit (Neonatal Intensive Care Unit, Pediatric Intensive Care Unit, Pediatric Hematology-Oncology unit).
- Strongly suspected or confirmed systemic infection.
- Subject planned to start on intravenous amoxicillin-clavulanic acid, piperacillin-tazobactam or meropenem treatment at least aimed for a minimum duration of two days at time of inclusion. If the subject was previously treated with the same beta-lactam, the minimum interval to the previous beta-lactam treatment episode is
- 40 hours for amoxicillin-clavulanic acid (based on elimination half-life)
- 8 hours for piperacillin-tazobactam and meropenem (based on elimination half-life) Subject planned to start on intravenous amoxicillin (without clavulanic acid) will not be included.
- Informed consent/assent signed by parents or legal representatives of the subject.
- Not previously enrolled in this trial.
Who cannot join
- Subject with serum creatinine level ≥ 2 mg/L at inclusion.
- Subject receiving (or planned to receive) haemofiltration, extracorporeal membrane oxygenation, hemodialysis or peritoneal dialysis, molecular adsorbent recirculating system or any other exchange technique.
- Subject receiving (or planned to receive) body cooling.
- Subject death is deemed imminent and inevitable.
- Reporting of first dosing advice (based on blood sampling) is not possible within 28 hours (*) after start treatment.
- The subject is known or suspected to be pregnant.
- The subject has a known allergy to the specific beta-lactam antibiotic.
- () The first (a posteriori) dose calculation and dose adjustment if necessary, is performed within a maximum timeframe of 28 hours after start of treatment (i.e. maximum timeframe to first dose adjustment).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
Ghent University Hospital
Ghent, 9000
Pieter De Cock, Prof., +32 9 332 29 69, pieter.decock@uzgent.be
Evelyn Dhont
About this study
Official title: Early Model-Informed Precision Dosing of Beta-lactam Antibiotics in Critically Ill Children: Big Solution for Small People?
The overall objective of this study is to investigate the impact of early model-informed precision dosing (MIPD) on target attainment of three beta-lactam antibiotics (amoxicillin-clavulanic acid, piperacillin-tazobactam and meropenem) in critically ill children. This evaluation includes a comparison with the more standard approach on clinical and patient-oriented measures.
- Conditions
- Amoxicillin-clavulanate, Piperacillin-tazobactam, Meropenem
- Being tested
- Beta-lactam antibiotic, Beta-lactam model-informed precision dosing
- Keywords
- amoxicillin-clavulanate, piperacillint-tazobactam, meropenem, model-informed precision dosing, dose calculator, critically ill children
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Beta-lactam antibioticDrug
Also called amoxicillin-clavulanic acid, piperacillin-tazobactam, meropenem
amoxicillin-clavulanic acid, piperacillin-tazobactam, meropenem treatment
Beta-lactam model-informed precision dosingDevice
Also called Dosing calculator
A dosing calculator is used for the prediction of starting doses (a priori dose predictions) and follow-up doses (a posteriori calculations), using a target 100% fT>MIC.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care beta-lactam treatment | Active comparator | Beta-lactam standard-of-care dosing regimen, as currently used at participating wards, during 28 day study period Receives: Drug: Beta-lactam antibiotic |
| Beta-lactam model-informed precision dosing | Experimental | fT>MIC-based model-informed precision dosing of beta-lactam antibiotics using a dosing calculator during 28 day study period. Receives: Drug: Beta-lactam antibiotic; Device: Beta-lactam model-informed precision dosing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects reaching the therapeutic target 100% fT>MIC
fT>MIC refers to the percentage of the dosing interval during which the beta-lactam concentration remains above the Minimum Inhibitory Concentration (MIC).
A target lower boundary for trough concentrations is set to achieve 100% fT>MIC.
A conservative upper threshold for trough concentrations of 100% fT>4xMIC is used.
Therefore, the therapeutic target range is 10-40 mg/L for amoxicillin (*), 18-72 mg/L for piperacillin () and 2-8 mg/L for meropenem (*).
(*) 10 mg/L for amoxicillin: taking into account a EUCAST breakpoint (for Escherichia coli infections) of 8 mg/L and a plasma protein binding of 18%.
(**) 18 mg/L for piperacillin: taking into account a EUCAST breakpoint (for wild-type Pseudomonas spp. infections) of 16 mg/L and a plasma protein binding of 9%.
(***) 2 mg/L for meropenem: taking into account a EUCAST breakpoint of 2 mg/L (for wild-type Enterobacterales species) and a plasma protein binding of 2%.
Measured: At 48 hours after start of beta-lactam treatment
Secondary outcomes (3)
Proportion of subjects reaching the therapeutic target 100% fT>MIC
The therapeutic target range is 10-40 mg/L for amoxicillin, 18-72 mg/L for piperacillin and 2-8 mg/L for meropenem.
Measured: At 120 hours after start of beta-lactam treatment
Proportion of subjects reaching the therapeutic target 100% fT>MIC
The therapeutic target range is 10-40 mg/L for amoxicillin, 18-72 mg/L for piperacillin and 2-8 mg/L for meropenem.
Measured: Within the interval 48 to 72 hours after start of beta-treatment
Hospital length-of-stay
Number of days from randomization to hospital discharge. Patients who are not discharged from hospital within 28 days will be censored at 28 days, the maximum follow up time. Patients who die before hospital discharge will also be censored at 28 days.
Measured: From date of randomization until date of hospital discharge, with a maximum of 28 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2025
- Study start9 Jul 2025
- Primary completion1 Oct 2027 (estimated)
- Study completion1 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amoxicillin-clavulanateStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Evelyn Dhont, Dr., Principal investigator, Ghent University Hospital, Princess Elisabeth Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06929702
- Sponsor's protocol ID
- ONZ-2024-0295
- Other IDs
- 2024-516447-12-00
- Acronym
- MOMENTUM
- Status last verified
- Sep 2026
- First submitted
- 13 Jan 2025
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Model-Informed Precision Dosing of Beta-lactam Antibiotics in Critically Ill Children: Big Solution for Small People?
- ClinicalTrials.gov ID
- NCT06929702
- Acronym / sponsor ID
- MOMENTUM / ONZ-2024-0295
- Conditions
- Amoxicillin-clavulanate, Piperacillin-tazobactam, Meropenem
- Keywords
- amoxicillin-clavulanate, piperacillint-tazobactam, meropenem, model-informed precision dosing, dose calculator, critically ill children
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- 9 Jul 2025 (actual)
- Primary completion
- 1 Oct 2027 (estimated)
- Study completion
- 1 Oct 2027 (estimated)
- First posted
- 16 Apr 2025 (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 overall objective of this study is to investigate the impact of early model-informed precision dosing (MIPD) on target attainment of three beta-lactam antibiotics (amoxicillin-clavulanic acid, piperacillin-tazobactam and meropenem) in critically ill children. This evaluation includes a comparison with the more standard approach on clinical and patient-oriented measures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care beta-lactam treatment | Active comparator | Drug: Beta-lactam antibioticBeta-lactam standard-of-care dosing regimen, as currently used at participating wards, during 28 day study period |
| Beta-lactam model-informed precision dosing | Experimental | Drug: Beta-lactam antibiotic, Device: Beta-lactam model-informed precision dosingfT>MIC-based model-informed precision dosing of beta-lactam antibiotics using a dosing calculator during 28 day study period. |
Who may qualify
- Ages
- 0 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- Subject aged between 0 - 17 years 10 months.
- Subject admitted to a participating ward unit (Neonatal Intensive Care Unit, Pediatric Intensive Care Unit, Pediatric Hematology-Oncology unit).
- Strongly suspected or confirmed systemic infection.
- Subject planned to start on intravenous amoxicillin-clavulanic acid, piperacillin-tazobactam or meropenem treatment at least aimed for a minimum duration of two days at time of inclusion. If the subject was previously treated with the same beta-lactam, the minimum interval to the previous beta-lactam treatment episode is
- 40 hours for amoxicillin-clavulanic acid (based on elimination half-life)
Key exclusion criteria (8 listed)
- Subject with serum creatinine level ≥ 2 mg/L at inclusion.
- Subject receiving (or planned to receive) haemofiltration, extracorporeal membrane oxygenation, hemodialysis or peritoneal dialysis, molecular adsorbent recirculating system or any other exchange technique.
- Subject receiving (or planned to receive) body cooling.
- Subject death is deemed imminent and inevitable.
- Reporting of first dosing advice (based on blood sampling) is not possible within 28 hours (*) after start treatment.
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 |
|---|---|---|
| Beta-lactam antibioticAlso: amoxicillin-clavulanic acid, piperacillin-tazobactam, meropenemamoxicillin-clavulanic acid, piperacillin-tazobactam, meropenem treatment | Drug | Beta-lactam model-informed precision dosing, Standard of Care beta-lactam treatment |
| Beta-lactam model-informed precision dosingAlso: Dosing calculatorA dosing calculator is used for the prediction of starting doses (a priori dose predictions) and follow-up doses (a posteriori calculations), using a target 100% fT>MIC. | Device | Beta-lactam model-informed precision dosing |
Primary outcome
Proportion of subjects reaching the therapeutic target 100% fT>MIC
Time frame: At 48 hours after start of beta-lactam treatment
fT>MIC refers to the percentage of the dosing interval during which the beta-lactam concentration remains above the Minimum Inhibitory Concentration (MIC). A target lower boundary for trough concentrations is set to achieve 100% fT>MIC. A conservative upper threshold for trough concentrations of 100% fT>4xMIC is used. Therefore, the therapeutic target range is 10-40 mg/L for amoxicillin (*), 18-72 mg/L for piperacillin () and 2-8 mg/L for meropenem (*). (*) 10 mg/L for amoxicillin: taking into account a EUCAST breakpoint (for Escherichia coli infections) of 8 mg/L and a plasma protein binding of 18%. (**) 18 mg/L for piperacillin: taking into account a EUCAST breakpoint (for wild-type Pseudomonas spp. infections) of 16 mg/L and a plasma protein binding of 9%. (***) 2 mg/L for meropenem: taking into account a EUCAST breakpoint of 2 mg/L (for wild-type Enterobacterales species) and a plasma protein binding of 2%.
3 secondary outcomes
Proportion of subjects reaching the therapeutic target 100% fT>MIC
Time frame: At 120 hours after start of beta-lactam treatment
Proportion of subjects reaching the therapeutic target 100% fT>MIC
Time frame: Within the interval 48 to 72 hours after start of beta-treatment
Hospital length-of-stay
Time frame: From date of randomization until date of hospital discharge, with a maximum of 28 days.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
Related trials for Amoxicillin-clavulanate
RecruitingPhase 4
Antibiotic Tissue Penetration and Tissue Response in Head and Neck Infection and Reconstructive Surgery
Surgical Wound Infection, Neck Infection
RecruitingPhase 3
Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community- Acquired Pneumonia
Respiratory Tract Diseases, Influenza (Pandemic)
Not yet recruitingPhase 4
Amoxicillin-clavulanate Versus Amoxicillin Versus Placebo in Acute Otitis Media in Children
Acute Otitis Media, AOM - Acute Otitis Media
Recruiting
Pediatric Antibiotic Dosing in Extracorporal Membrane Oxygenation (PADECMO)
Pharmacokinetics, Amoxicillin-clavulanate
RecruitingObservational study
Antibiotic Dosing in Pediatric Intensive Care
Pharmacokinetics, Amoxicillin-clavulanate
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.
Evelyn Dhont, Dr. principal investigator
Ghent University Hospital, Princess Elisabeth Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Beta-lactam antibiotic and Beta-lactam model-informed precision dosing in people with Amoxicillin-clavulanate and Piperacillin-tazobactam, 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 8 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 17 Sep 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 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pieter De Cock, Prof. (+32 9 332 29 69, pieter.decock@uzgent.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of subjects reaching the therapeutic target 100% fT>MIC (time frame: At 48 hours after start of beta-lactam treatment). 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 17 Sep 2026.