RecruitingNAINTERVENTIONAL

Impact of Procalcitonin-guided Algorithm on Early Discontinuation of Antibiotic Therapy

This study, conducted in French children's intensive care units, is investigating whether a special blood test, called procalcitonin (PCT), can help doctors know when it's safe to stop giving antibiotics to seriously ill children with bacterial infections. Children will either have their antibiotic treatment guided by this PCT test or by the usual doctor's judgment. The main goal is to see if using the PCT test can safely shorten the time children are on antibiotics. Long courses of antibiotics can sometimes lead to problems like drug-resistant infections. The study will involve nearly 300 children and they will be followed for up to 28 days to see how well they recover and if infections come back.

At a glance

Status

Recruiting

Phase

Sponsor

University Hospital, Toulouse

Enrolment target

296

Start

02 May 2023

Estimated completion

02 Feb 2027

Bacterial Infections

What is this study about?

When children are very unwell with serious bacterial infections, they often need antibiotics. These medicines are very important for fighting off infections, but taking them for a long time can sometimes cause problems. For example, it can affect the 'good' bacteria in their body, lead to infections that are harder to treat (called antibiotic resistance), or cause other side effects.

This study is looking at a new way to help doctors decide when it's safe to stop antibiotics. It involves a simple blood test that measures something called procalcitonin (PCT). The idea is that if the PCT levels in the blood drop, it might mean the infection is clearing up and antibiotics can be stopped sooner. This approach has shown good results in adults, but more research is needed for children.

The study will compare two groups of children. One group will have their antibiotic treatment guided by this PCT blood test, while the other group will receive antibiotics based on the doctors' usual judgment and guidelines. By comparing these two groups, researchers hope to find out if using the PCT test can safely reduce the total time children are on antibiotics without making them sicker or causing their infection to come back. They will also look at the financial impact of using the test.

Key takeaways

The study aims to find out if a blood test can help reduce antibiotic use in seriously ill children.
It compares two ways of deciding when to stop antibiotics: current practice vs. using the PCT blood test.
The main goal is to safely shorten the time children are on antibiotics.
Longer antibiotic courses can lead to side effects and antibiotic resistance.
Children will be monitored closely for 28 days to track recovery and any returning infections.

Who may be eligible?

This study is looking for babies and children who are in a children's intensive care unit (ICU) and have started intravenous (given into a vein) antibiotics for a suspected or confirmed bacterial infection less than 24 hours ago. For your child to be included, both parents or legal guardians must be able to give written permission and speak French, and your family needs to be part of a social security scheme.

However, some children won't be able to take part. This includes very young newborns (less than 3 days old or born very early, under 37 weeks, based on when they should have been born), and anyone aged 18 or older. Pregnant or breastfeeding women are also excluded. Children with certain long-term health conditions, like cystic fibrosis, or problems with their immune system (which fights off infections) cannot join.

Also, children with certain conditions that can naturally raise their PCT levels, like severe burns or recent major heart surgery, are not eligible. Finally, children with specific types of infections that always need a very long course of antibiotics (such as some bone infections or serious internal abscesses) cannot be included in this 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 a children's intensive care unit (ICU)?
Have they started antibiotics through an IV less than 24 hours ago?
Is your child between 3 days and 17 years old?
Do both parents or legal guardians speak French and can give written consent?
Does your child have cystic fibrosis or a known immune system problem?
Does your child have a type of infection that doctors always treat with antibiotics for a very long time?

Answer every question to see your result.

What does participation involve?

If your child is eligible and you agree for them to take part, they will be randomly assigned to one of two groups. In one group, your child's doctors will use the procalcitonin (PCT) blood test results, along with their clinical condition, to decide when to stop antibiotics. In the other group, antibiotics will be stopped based on your child's doctors' usual judgment and medical guidelines.

If your child is in the PCT-guided group, they will have blood tests for PCT on the day they join the study, the next day, and then every 48 hours until they finish antibiotics or leave the hospital (unless they're discharged still on antibiotics). Your child's overall hospital stay and health will be monitored for up to 28 days after they join the study, or until they are discharged from the hospital. The study will also track any infections that might come back up to 28 days after joining.

Potential risks and benefits

Participating in this study might offer your child the potential benefit of a shorter course of antibiotics, which could reduce side effects and the risk of developing antibiotic-resistant infections. However, there's also a small chance that stopping antibiotics earlier could lead to an infection coming back, though this is carefully monitored. The main risk involves extra blood tests for the PCT group, which means more needle pricks. You have the right to withdraw your child from the study at any time without affecting their medical care.

Locations (7)

CHU Amiens Picardie
Verified postcode
Amiens, France· Active not recruiting
CHU de Bordeaux
Verified postcode
Bordeaux, France· Active not recruiting
CHU de Clermont Ferrand
Verified postcode
Clermont-Ferrand, France· Recruiting
CHU de NANTES
Verified postcode
Nantes, France· Recruiting
APHP
Verified postcode
Paris, France· Active not recruiting
CHU La Réunion
Verified postcode
Saint-Denis, France· Recruiting
University Hospital of Toulouse
Verified postcode
Toulouse, France· Recruiting

Common questions

What is procalcitonin (PCT)?

Procalcitonin (PCT) is a substance in the blood that can increase when there's a serious bacterial infection. Doctors can measure its levels to help understand how an infection is progressing.

Why is it important to shorten antibiotic treatment?

Long courses of antibiotics can sometimes lead to side effects, disrupt the 'good' bacteria in the body, and increase the risk of bacteria becoming resistant to these medicines.

Will my child still get the care they need?

Yes, all children in the study will receive the best possible medical care for their condition, regardless of which group they are in.

What happens if an infection comes back?

The medical team will closely monitor your child. If an infection comes back or worsens, they will receive appropriate treatment, including restarting antibiotics if necessary.

Is this approach used in adults?

Yes, using PCT to guide antibiotic treatment has shown good results in critically ill adults, helping to safely reduce how long they need antibiotics.

How to find out more

Romain AMADIEU, MD

amadieu.r@chu-toulouse.fr 053-455-7495 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.