VancomycinPhase 4BENEFICIALNCT04666948
Precision Dosing of Vancomycin in Critically Ill Children
A Phase 4 study testing vancomycin model-informed precision dosing and Vancomycin in people with Vancomycin, run by University Hospital, Ghent at 7 sites in Belgium.
Trial summary
The overall objective of this project is to investigate the large-scale utility of MIPD of vancomycin at point-of-care in ICU children. This evaluation includes a comparison with the more standard approach on Clinical and patient-oriented measures. Read more about this study
- Who is it for?
- Ages 0 days to 15 years
- Conditions the study is for
- Vancomycin
- What is being tested?
- vancomycin model-informed precision dosing and Vancomycin
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 314 participants
- Where
- 7 sitesBelgium
- Study dates
- 28 Dec 2020to 30 Oct 2024
- Phase
- Phase 4
- 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 0 days to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- age: 0-18 years
- admitted to ICU or PHO unit
- suspected or confirmed Gram positive infection
- planned to start on intravenous intermittent or continuous infusion vancomycin treatment
- informed consent signed by parents or legal representatives
- not previously enrolled in this trial
Who cannot join
- extracorporeal treatment at inclusion or started during treatment (extracorporeal membrane oxygenation, dialysis, body cooling)
- n or p RIFLE category failure at inclusion (Day 0) (see section 8.1.2. screening)
- Known chronic kidney disease as defined by the KDIGO definition as: structural or functional abnormalities of the kidney regardless of GFR for < 3 months or GFR < 60ml/min/1.73m² for ≥ 3 months. eGFR is estimated using the modified Schwartz equation
- patient death is deemed imminent and inevitable
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Belgium7 sites
AZ Sint-Jan Brugge-Oostende AV
Bruges
Erasme
Brussels, Brussels Capital
Cliniques universitaires de Saint Luc
Brussels
Hopital universitaire de Reine Fabiola
Brussels
UZ Brussel
Brussels
Ghent University Hospital
Ghent
UZ Leuven
Leuven
About this study
Official title: A Multicentric, Randomised Controlled Clinical Trial to Study the Impact of Bedside Model-informed Precision Dosing of Vancomycin in Critically Ill Children
The overall objective of this project is to investigate the large-scale utility of MIPD of vancomycin at point-of-care in ICU children. This evaluation includes a comparison with the more standard approach on Clinical and patient-oriented measures.
Read the detailed description
Vancomycin is an antibiotic with a narrow therapeutic-toxic margin. This means that the minimum and maximum target blood target levels differ little from each other. Too low concentrations will reduce the effect of the antibiotic; higher concentrations may result in serious side effects, including renal toxicity. Vancomycin dosing tailored to the critically ill child is challenging.
Currently, the starting dose of vancomycin is calculated on a milligram per kilogram basis, which is the same for all patients. The dose is then adjusted based on a measured vancomycin blood concentration (if too high or too low). Despite this measurement, quickly achieving target concentrations remains a major challenge.
This multicenter, individual randomized study investigates the added value of a user-friendly computer program for calculating the vancomycin dose in critically ill children, compared to the current standard-of-care. Specifically, the investigators will study whether the use of this computer program leads to a shorter time to reach target concentrations, a reduction in the number and severity of side effects on the kidney, a reduction in patient burden, and a reduction in time to cure and duration of hospitalization.
- Conditions
- Vancomycin
- Being tested
- vancomycin model-informed precision dosing, Vancomycin
- Keywords
- vancomycin, model-informed precision dosing, critically ill children, dose calculator
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vancomycin model-informed precision dosingDevice
Also called dosing calculator
A CE labelled dosing calculator is used for a priori and a posteriori calculation of vancomycin dose using a target AUC between 400-600 mg*h/L
VancomycinDrug
Vancomycin treatment
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care Vancomycin treatment | Active comparator | Vancomycin standard-of-care dosing and therapeutic drug monitoring, according to institutional guidelines during 30 day study period Receives: Drug: Vancomycin |
| vancomycin model-informed precision dosing | Experimental | Area Under the Concentration (AUC)-time curve/MIC-based model-informed precision dosing of vancomycin using a CE labelled dosing calculator during 30 day study period Receives: Device: vancomycin model-informed precision dosing; Drug: Vancomycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients reaching target 24hAUC/MIC
therapeutic AUC/MIC target range is 400-600
Measured: 24 to 48 hours after start vancomycin treatment
Secondary outcomes (6)
Proportion of patients with (worsening) acute kidney injury during vancomycin treatment
AKI categories are defined according to the neonatal and pediatric RIFLE criteria
Measured: from start date of vancomycin treatment until stop date vancomycin treatment or study day 30, whichever comes first
Proportion of patients reaching target 24h AUC/MIC
therapeutic AUC/MIC target range is 400-600
Measured: 48-72 hours after start vancomycin treatment
Time to clinical cure
Time to clinical cure is defined as the time interval (in days) from start to completion of the vancomycin vancomycin treatment, without recommencement of antibiotics for the same indication within 48h after stop.
Measured: 30 day study period
Ward unit length-of-stay
Ward unit length-of-stay is calculated from day of ward unit admission to day of ward unit discharge.
Measured: 30 day study period
Hospital length-of-stay
Hospital unit length-of-stay is calculated from day of hospital admission to day of hospital discharge.
Measured: 30 day study period
30 day all cause mortality
30 day all cause mortality is measured 30 days after randomisation.
Measured: 30 day study period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2020
- Study start28 Dec 2020
- Primary completion14 Dec 2023
- Study completion30 Oct 2024
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 VancomycinStudies 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
- 314 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- Belgium Health Care Knowledge Centre, University Ghent
- Responsible party
- Sponsor
- Investigators
- Pieter De Cock, Prof, Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04666948
- Sponsor's protocol ID
- BC-5429
- Acronym
- BENEFICIAL
- Status last verified
- Jan 2026
- First submitted
- 28 Nov 2020
- Last updated
- 16 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
De Cock PA, Colman R, Smits A, Piersigilli F, Renard M, Van Damme A, Clarysse A, Dhont E, Vanhaesebrouck S, Bordon V, Boland L, De Wilde B, Amza A, Vanlanduyt L, Nguyen TVA, Cools F, van der Werff Ten Bosch J, Vens D, Derriks F, Houtekie L, Mauel R, Van der Linden D, Schelstraete P; BENEFICIAL study group. Bedside model-informed precision dosing of vancomycin in severely ill neonates and children in Belgium (the BENEFICIAL trial): a multicentre, randomised controlled trial. Lancet Child Adolesc Health. 2026 Jun;10(6):406-417. doi: 10.1016/S2352-4642(25)00385-2. Epub 2026 Apr 10.
PubMed 41974145
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentric, Randomised Controlled Clinical Trial to Study the Impact of Bedside Model-informed Precision Dosing of Vancomycin in Critically Ill Children
- ClinicalTrials.gov ID
- NCT04666948
- Acronym / sponsor ID
- BENEFICIAL / BC-5429
- Conditions
- Vancomycin
- Keywords
- vancomycin, model-informed precision dosing, critically ill children, dose calculator
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 314 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Collaborators
- Belgium Health Care Knowledge Centre, University Ghent
- Study start
- 28 Dec 2020 (actual)
- Primary completion
- 14 Dec 2023 (actual)
- Study completion
- 30 Oct 2024 (actual)
- First posted
- 14 Dec 2020 (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 project is to investigate the large-scale utility of MIPD of vancomycin at point-of-care in ICU children. This evaluation includes a comparison with the more standard approach on Clinical and patient-oriented measures.
Detailed description
Vancomycin is an antibiotic with a narrow therapeutic-toxic margin. This means that the minimum and maximum target blood target levels differ little from each other. Too low concentrations will reduce the effect of the antibiotic; higher concentrations may result in serious side effects, including renal toxicity. Vancomycin dosing tailored to the critically ill child is challenging.
Currently, the starting dose of vancomycin is calculated on a milligram per kilogram basis, which is the same for all patients. The dose is then adjusted based on a measured vancomycin blood concentration (if too high or too low). Despite this measurement, quickly achieving target concentrations remains a major challenge.
This multicenter, individual randomized study investigates the added value of a user-friendly computer program for calculating the vancomycin dose in critically ill children, compared to the current standard-of-care. Specifically, the investigators will study whether the use of this computer program leads to a shorter time to reach target concentrations, a reduction in the number and severity of side effects on the kidney, a reduction in patient burden, and a reduction in time to cure and duration of hospitalization.
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 Vancomycin treatment | Active comparator | Drug: VancomycinVancomycin standard-of-care dosing and therapeutic drug monitoring, according to institutional guidelines during 30 day study period |
| vancomycin model-informed precision dosing | Experimental | Device: vancomycin model-informed precision dosing, Drug: VancomycinArea Under the Concentration (AUC)-time curve/MIC-based model-informed precision dosing of vancomycin using a CE labelled dosing calculator during 30 day study period |
Who may qualify
- Ages
- 0 days to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- age: 0-18 years
- admitted to ICU or PHO unit
- suspected or confirmed Gram positive infection
- planned to start on intravenous intermittent or continuous infusion vancomycin treatment
- informed consent signed by parents or legal representatives
Key exclusion criteria (4 listed)
- extracorporeal treatment at inclusion or started during treatment (extracorporeal membrane oxygenation, dialysis, body cooling)
- n or p RIFLE category failure at inclusion (Day 0) (see section 8.1.2. screening)
- Known chronic kidney disease as defined by the KDIGO definition as: structural or functional abnormalities of the kidney regardless of GFR for < 3 months or GFR < 60ml/min/1.73m² for ≥ 3 months. eGFR is estimated using the modified Schwartz equation
- patient death is deemed imminent and inevitable
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 |
|---|---|---|
| vancomycin model-informed precision dosingAlso: dosing calculatorA CE labelled dosing calculator is used for a priori and a posteriori calculation of vancomycin dose using a target AUC between 400-600 mg*h/L | Device | vancomycin model-informed precision dosing |
| VancomycinVancomycin treatment | Drug | Standard of Care Vancomycin treatment, vancomycin model-informed precision dosing |
Primary outcome
Proportion of patients reaching target 24hAUC/MIC
Time frame: 24 to 48 hours after start vancomycin treatment
therapeutic AUC/MIC target range is 400-600
6 secondary outcomes
Proportion of patients with (worsening) acute kidney injury during vancomycin treatment
Time frame: from start date of vancomycin treatment until stop date vancomycin treatment or study day 30, whichever comes first
Proportion of patients reaching target 24h AUC/MIC
Time frame: 48-72 hours after start vancomycin treatment
Time to clinical cure
Time frame: 30 day study period
Ward unit length-of-stay
Time frame: 30 day study period
Hospital length-of-stay
Time frame: 30 day study period
30 day all cause mortality
Time frame: 30 day study period
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 16 Jan 2026.
- Derived from this study: PubMed 41974145De Cock PA, Colman R, Smits A, Piersigilli F, Renard M, Van Damme A, Clarysse A, Dhont E, Vanhaesebrouck S, Bordon V, Boland L, De Wilde B, Amza A, Vanlanduyt L, Nguyen TVA, Cools F, van der Werff Ten Bosch J, Vens D, Derriks F, Houtekie L, Mauel R, Van der Linden D, Schelstraete P; BENEFICIAL study group. Bedside model-informed precision dosing of vancomycin in severely ill neonates and children in Belgium (the BENEFICIAL trial): a multicentre, randomised controlled trial. Lancet Child Adolesc Health. 2026 Jun;10(6):406-417. doi: 10.1016/S2352-4642(25)00385-2. Epub 2026 Apr 10.
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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.
Pieter De Cock, Prof principal investigator
University Hospital, Ghent
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing vancomycin model-informed precision dosing and Vancomycin in people with Vancomycin, run by University Hospital, Ghent at 7 sites 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 6 inclusion and 4 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 16 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 7 sites 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?
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?
Proportion of patients reaching target 24hAUC/MIC (time frame: 24 to 48 hours after start vancomycin treatment). 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 NCT04666948, 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 16 Jan 2026; AzTrials last refreshed its copy on 2 Nov 2026.