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Can a dosing calculator hit the target for sick Kids' antibiotics?

NCT ID NCT06929702

Disease control Sponsor: University Hospital, Ghent Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 17, 2026 · Last updated Sep 18, 2026 · Updated 1 time

Summary

Researchers test whether a computer-based dosing calculator can help hit the right antibiotic levels in critically ill children. The trial includes children aged 0 to 17 years 10 months who are admitted to intensive care or cancer units and need intravenous antibiotics for a suspected or confirmed infection. The calculator predicts starting and follow-up doses for three common beta-lactam antibiotics, aiming to keep drug levels above the minimum needed to kill bacteria. The study compares this approach with standard dosing to see which achieves the target more often.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
beta-lactam antibiotics (amoxicillin-clavulanic acid, piperacillin-tazobactam, meropenem)
What this could lead to
If it works, this could help doctors give critically ill children more accurate antibiotic doses, improving treatment success and reducing the risk of resistant infections.
What could go wrong
The trial is small and early, so it may not show a clear benefit over standard dosing. The dosing calculator might not work well for all children, and the study does not test whether better drug levels actually lead to better recovery.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 58 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2025

Expected to finish

Oct 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

0 to 18 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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. Exclusion Criteria: * 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).

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Amoxicillin-clavulanate Meropenem Piperacillin-tazobactam

How to take part

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

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Contacts and locations

Locations

  • Ghent University Hospital

    RECRUITING

    Ghent, 9000, Belgium

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