Population Pharmacokinetics of Anti-infectives in Critically Ill Children
This study focuses on understanding how anti-infective medicines, like antibiotics, work in sick children admitted to intensive care. Sometimes, children might not get enough medicine, which means it might not fight infections effectively. Also, every child is different, so the same dose might affect them in various ways. The researchers aim to figure out the best dose for each child by studying how their bodies handle these medicines. They'll collect blood samples to measure medicine levels and see how well the treatment works. The goal is to create more personalised treatment plans, ensuring children receive the right amount of medicine to get better and avoid future health problems.
At a glance
What is this study about?
This research study is about helping seriously ill children get the best possible treatment for infections. When children are very sick, their bodies can react differently to medicines compared to adults or even other children. This means that medicines like antibiotics, which fight infections, might not always work as expected.
Sometimes, children might not get enough of the medicine, which could mean the infection doesn't go away properly. Other times, they might get too much. Because figuring out the exact right dose can be tricky, this study wants to make sure that each child receives the perfect amount of anti-infective medicine tailored to their needs. This way, the medicine can be as effective as possible in fighting off infections.
The researchers will study how a child's body processes these medicines and how those levels affect their recovery. They hope to learn why different children respond in different ways. By understanding this better, doctors can make more informed decisions about dosing, helping to improve how children recovering in intensive care are treated for infections.
Key takeaways
- This study aims to find the right doses of infection-fighting medicines for seriously ill children.
- It will help doctors give personalised treatment to children in intensive care.
- Participation involves collecting small extra blood samples during existing treatment.
- No new medicines or treatments are given as part of the study.
- The findings could improve care for future children battling infections.
Who may be eligible?
This study is looking for children who are aged between 1 day and 18 years old. They must be receiving or about to receive an anti-infective medicine during their hospital stay or follow-up appointments. These medicines include various types of antibiotics and antivirals.
Children will not be able to join the study if their parents or guardians have told the doctor they do not want information about their child to be used for research. Also, older children who can understand the study information can choose not to participate if they don't want their data collected.
Overall, if your child is under 18, is taking or about to take a medicine for an infection, and you (and your child, if able to understand) agree to participate, they might be eligible.
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 between 1 day and 18 years old?
- Is your child currently receiving (or about to receive) medicine for an infection?
- Are you comfortable with your child having a few extra blood samples taken?
- Have you (and your child, if old enough) not told the doctor you don't want to participate?
What does participation involve?
If your child is eligible and you agree for them to take part, the main thing involved is simply allowing blood samples to be taken. During the time your child is receiving their anti-infective medicine, six small blood samples will be collected. These samples will be taken at different times during the period between regular medicine doses.
Importantly, there will be no extra procedures, visits, or medicines given specifically for this study. Your child will continue to receive the care and medicines planned by their medical team as usual. The study simply collects information and small blood samples from treatments already happening, without any extra cost to you. The hospital's senior doctor will explain everything in more detail, and if your child is old enough, they will also be given information to understand what's happening.
Potential risks and benefits
Locations (1)
- Hospital Necker - Enfants Malades (Public Hospitals of Paris)Verified postcodeParis, France· Recruiting
Common questions
What kind of medicines are 'anti-infectives'?
Anti-infectives are medicines that fight infections, such as antibiotics (for bacteria), antifungals (for fungi), and antivirals (for viruses).
Will my child receive extra medicine for this study?
No, your child will only receive the medicines their doctors have already prescribed as part of their standard care. No additional medicines are given for the study.
Why are blood samples needed?
Blood samples help doctors measure how much of the anti-infective medicine is in your child's body. This helps them understand the best dose for sick children.
Will this study change my child's medical treatment?
No, your child's medical treatment will remain exactly the same as planned by their care team. The study collects information from their existing treatment.
Can I decide not to let my child participate?
Yes, you have the full right to say no at any time, and this will not affect your child's medical care in any way.
How to find out more
Oualha Mehdi, MD,PhD
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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