AuthorisedTherapeutic use (Phase IV)Interventional

A single-centre, partially blind, randomised, parallel-group, two-arms, superiority study to compare the efficacy and safety of extended (3 h) and intermittent infusion (0.5 h) of β-lactams (cefepime, ceftriaxone, meropenem, piperacillin/tazobactam) in critically ill paediatric patients (PEBBLE)

This study focuses on how to give certain antibiotics, like cefepime and meropenem, to seriously ill children who have infections. The main goal is to find out if giving these powerful medicines slowly over a 3-hour period is better and safer than giving them more quickly over half an hour. Researchers are studying children in intensive care to see which method helps the antibiotics work best in their bodies and improves their recovery. They'll also be looking for any side effects. This research aims to understand the best way to use these important medications to help critically ill children fight off infections and get well.

At a glance

Status

Authorised

Phase

Therapeutic use (Phase IV)

Sponsor

Semmelweis University

Enrolment target

110

Start

24 Jul 2025

suspected or proven infection critical illness

What is this study about?

This study, called PEBBLE, is looking at how we can give antibiotics most effectively to children who are very poorly and are being cared for in intensive care. When someone has a serious infection, antibiotics are crucial. These often need to be given directly into the bloodstream through a drip.

Doctors want to know the best way to give these specific antibiotics (cefepime, ceftriaxone, meropenem, and piperacillin/tazobactam) to make them work as well as possible while keeping children safe. They are comparing two ways: giving the medicine slowly over three hours, or giving it more quickly over half an hour. The idea is that the length of time the medicine is in the body might change how well it fights the infection. The study hopes to find out which way leads to better results for the children involved.

The study will look at several things, including how well the antibiotics clear the infection, how quickly children feel better, and if there are any side effects. By understanding the best way to give these medicines, doctors can improve care for other seriously ill children with infections in the future.

Key takeaways

This study compares different ways of giving antibiotics to very sick children.
It aims to find out if giving antibiotics slowly or quickly is better for fighting infections.
Children in intensive care with suspected or proven infections are included.
The research helps doctors improve how they treat serious infections in children.
Your child's safety and well-being are the top priority throughout the study.

Who may be eligible?

This study is for children of any age who are seriously ill and are being treated in intensive care. All children will have either a suspected or confirmed infection.

Whether a child can take part will depend on specific medical details that their doctors will check carefully. Both boys and girls can participate in the study.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Is your child currently in intensive care?
Does your child have a serious infection, or is one suspected?
Is your child able to receive one of the antibiotics being studied?
Is your child of any age?

Answer every question to see your result.

What does participation involve?

If your child takes part, they will receive one of the study antibiotics, either given over 3 hours or over 30 minutes, as decided by a random draw (like flipping a coin). They will have regular blood tests to check how much of the antibiotic is in their system and how their body is responding to treatment. Doctors will also closely monitor their overall health, including signs of infection and any side effects, every day during their time in the hospital. The study will follow their progress until they either leave the hospital or for up to 30 days, whichever comes first.

Potential risks and benefits

While taking part, your child will receive standard antibiotics for their infection. The potential benefit is that we might find a more effective way to give these medicines, which could help your child recover better and faster. As with any medical treatment, there's always a risk of side effects from the antibiotics, which will be carefully monitored. You are free to withdraw your child from the study at any time without affecting their medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Hungary

Common questions

What kind of antibiotics are being studied?

The study is looking at common and strong antibiotics like cefepime, ceftriaxone, meropenem, and piperacillin/tazobactam that are used for serious infections.

Who decides which way my child gets the antibiotic?

Which method your child receives (slow or fast infusion) is chosen randomly, like drawing a name out of a hat, to make the study fair.

Will my child's regular medical care be affected?

No, participating in the study will not affect your child's standard medical care. They will still receive all the treatment they need.

What happens after the study ends for my child?

The study will follow your child's progress until they are discharged from the hospital or for up to 30 days. Their medical care will then continue as usual.

What if I change my mind about my child participating?

You can withdraw your child from the study at any time, for any reason, and it will not affect their ongoing medical treatment.