RecruitingOBSERVATIONAL

Pre-clinical Diagnosis Using Integrated Microbial and Host Response Signatures to Improve Outcomes From Ventilator-associated Pneumonia in Critically Ill Children

This research is looking for new, quicker ways to spot a serious lung infection called Ventilator-Associated Pneumonia (VAP) in children who are very ill and need help breathing with a machine. Currently, it's hard to diagnose accurately, leading to lots of antibiotics being given, which can cause problems in the long run. We believe that by using new tests, such as looking at the germs in the lungs and how a child's body is reacting, we can help doctors diagnose VAP more precisely. This could mean children get the right treatment faster, spend less time in hospital, and harmful germs become less resistant to antibiotics. This study focuses on children aged one month to 16 years old.

At a glance

Status

Recruiting

Sponsor

University of Cambridge

Enrolment target

300

Start

14 Apr 2025

Estimated completion

30 Sep 2027

Ventilator Associated Pneumonia ( VAP)

What is this study about?

When children are very poorly and need a breathing machine, they can sometimes develop a serious lung infection called Ventilator-Associated Pneumonia, or VAP for short. This infection affects a significant number of children in intensive care every year and can make them much sicker, leading to longer stays in hospital and sometimes even being life-threatening. The big challenge for doctors is that VAP is currently very difficult to diagnose accurately and quickly. This often means antibiotics are given "just in case" – even if they're not always needed – which can lead to germs becoming resistant to these important medicines.

This study aims to find much better ways to diagnose VAP. We believe that by understanding more about how these infections develop – for example, how germs from the gut can end up in the lungs when a child is on a breathing machine – we can develop new, more precise tests. These tests could look directly at the specific germs causing the infection, as well as how the child's body is fighting it, using samples from their blood or lungs.

The main goal is to give doctors clearer information much faster. This will help them decide on the best treatment for each child, avoiding unnecessary antibiotics when possible. Ultimately, these new diagnostic methods could mean children recover more quickly, spend less time in intensive care, and we can help tackle the growing problem of antibiotic resistance, making sure these medicines work when they are truly needed.

Key takeaways

Aims to improve diagnosis of serious lung infections (VAP) in children on breathing machines.
Will look at new ways to identify germs and the body's response more accurately.
Could help children get the right treatment faster and reduce unnecessary antibiotic use.
Focuses on children aged 1 month to 16 years in intensive care.
Participation might involve providing samples for new tests.
Information gained will help future patients, rather than directly benefiting the child taking part.

Who may be eligible?

This study is particularly for children who are very poorly and are being cared for in a children's intensive care unit (PICU). To be considered, a child must have been on a breathing machine for at least two days.

However, there are some reasons why a child might not be able to join. For example, if they are already receiving end-of-life care, or if they have a breathing tube (tracheostomy) already in place before coming into intensive care. Children with known problems with their immune system, or those who have had a full course of antibiotics recently (in the last six weeks), would also not be able to take part.

Also, if there is any suspicion or confirmed diagnosis of tuberculosis (TB), a child unfortunately wouldn't be eligible. The study is open to both boys and girls, aged from one month old, right up to 16 years old.

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 month and 16 years old?
Is your child currently in a children's intensive care unit (PICU)?
Has your child been on a breathing machine for at least two days?
Is your child NOT receiving end-of-life care?
Does your child NOT already have a breathing tube (tracheostomy) from before this hospital stay?
Has your child NOT had a full course of antibiotics in the last 6 weeks?

Answer every question to see your result.

What does participation involve?

The description provided focuses on understanding and improving diagnosis, rather than stating what participation directly involves for a child beyond providing samples for testing. Typically, taking part in a study like this might involve giving extra blood samples or samples of fluid from the lungs (if already part of their routine care) for the specific tests being developed. These samples would help researchers identify different germs and how the child's body is responding. The study does not mention any new medications or treatments that participants would receive. The total duration of participation would likely depend on how long a child is in intensive care and on a breathing machine, and how long samples are needed for the study tests. There may be follow-up to see how the child's health progresses.

Potential risks and benefits

Participating in this study might not offer direct health benefits to the individual child, as it focuses on gathering information to help future patients. However, the information gathered could greatly improve how VAP is diagnosed and treated in the future, helping many other children. The main potential risks would be those associated with taking additional samples, like a slight discomfort from a blood test, though these would be done with the utmost care. All medical procedures carry some degree of risk, but researchers and medical staff will explain these fully. You would always have the right to withdraw your child from the study at any time, without it affecting their medical care.

Locations (1)

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

Cambridge University Hospitals NHS Foundation Trust
Verified postcode
Cambridge, United Kingdom· Recruiting

Common questions

What is VAP?

VAP stands for Ventilator-Associated Pneumonia. It's a type of serious lung infection that can happen to very sick children who are on a breathing machine in intensive care.

Why is it hard to diagnose VAP now?

Current ways to diagnose VAP aren't very precise, which means doctors sometimes have to guess or wait for test results, potentially giving antibiotics when not needed.

How might this study improve things?

This study hopes to find new, quicker tests that look at tiny germs and the body's response to help doctors diagnose VAP more accurately, so children get the right treatment faster.

Will my child receive new medicines in this study?

The information provided suggests the study focuses on developing better diagnostic tests, not new medicines. Your child would continue to receive their standard medical care.

Who can participate?

Seriously ill children aged 1 month to 16 years old, who have been on a breathing machine for at least 48 hours in intensive care, may be eligible. There are some specific reasons why a child might not be able to join.

How to find out more

Nazima Pathan, FRCPCH PhD

np409@medschl.cam.ac.uk +441223 805000 Official trial record

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