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Could a tailored antibiotic dose save more kids in the ICU?

NCT ID NCT04666948

Knowledge-focused Sponsor: University Hospital, Ghent Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether giving a personalized dose of the antibiotic vancomycin to critically ill children in the ICU leads to better results than the standard approach. Researchers enrolled 314 children and compared how many reached the target drug level in their blood. The goal was to see if tailoring the dose improves treatment and reduces side effects like kidney injury.

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

314 people

The number who actually took part.

Started

Dec 2020

Finished

Oct 2024

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 days to 15 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: * 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 Exclusion Criteria: * 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

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Conditions

The condition(s) this trial relates to.

gram-positive bacterial infections

As listed by the trial registrant

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

Vancomycin

Contacts and locations

Locations

  • AZ Sint-Jan Brugge-Oostende AV

    Bruges, Belgium

  • Cliniques universitaires de Saint Luc

    Brussels, Belgium

  • Erasme

    Brussels, Brussels Capital, Belgium

  • Ghent University Hospital

    Ghent, Belgium

  • Hopital universitaire de Reine Fabiola

    Brussels, Belgium

  • UZ Brussel

    Brussels, Belgium

  • UZ Leuven

    Leuven, Belgium

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