RecruitingOBSERVATIONAL

Systematic Screening for Primary Immunodeficiencies in Patients Admitted for Severe Infection in Pediatric Intensive Care Unit

This study aims to find out if children who are very ill with severe infections and admitted to a specialist children's intensive care unit might have an underlying problem with their immune system. Sometimes, healthy children get severe infections that doctors don't fully understand. Researchers want to see if these children have a hidden genetic weakness that makes them more likely to get seriously ill. By looking for these 'primary immune deficiencies,' they hope to learn more about why some severe infections happen and how to better help children in the future. The study is for children aged 3 months to 16 years who are in intensive care due to a serious infection.

At a glance

Status

Recruiting

Sponsor

University Hospital, Montpellier

Enrolment target

100

Start

04 Sep 2023

Estimated completion

04 Sep 2026

Severe Infection Severe Immune Deficiency

What is this study about?

This research study is looking at children who are admitted to a hospital's intensive care unit because of a very serious infection. Infections can be caused by germs like bacteria, viruses, or fungi. While many children get infections and recover well, some get really sick, and doctors sometimes don't know exactly why. This study wants to explore if some of these severe infections happen because of a hidden problem with a child's immune system.

The immune system is your body's natural defence against illness. A 'primary immune deficiency' means that someone was born with an immune system that doesn't work as well as it should. This isn't something you catch, but something you inherit or are born with. Until recently, doctors usually only looked for these problems if a child had many infections over time or very specific symptoms. However, researchers are now wondering if even a single, very severe infection might be a sign of an underlying immune system weakness.

The main goal of this study is to discover how often children with severe infections in intensive care actually have one of these underlying immune deficiencies. By understanding this better, doctors hope to gain more knowledge about severe infections in children and potentially find new ways to diagnose and help children who become very sick.

Key takeaways

The study looks for hidden immune problems in very sick children.
It focuses on children in intensive care with severe infections.
The goal is to understand why some severe infections occur.
It does not involve new treatments, just gathering information.
Participation requires parental consent.
Children can be withdrawn from the study at any time.

Who may be eligible?

This study is looking for children aged between 3 months and 16 years old. They must have a severe infection that has led to them being admitted to an intensive care unit for more than 24 hours at one of the participating hospitals (Montpellier, Toulouse, or Marseille). Examples of severe infections include serious brain infections, pneumonia, or infections causing 'sepsis' (when the body reacts very badly to an infection).

There are also reasons why a child would not be able to join the study. For instance, if their severe infection is not clearly documented, or if they have mild breathing problems like acute bronchiolitis without other complications. Also, children who already have a known long-term health problem or immune deficiency that explains their severe infection would not be eligible, as the study is looking for new, undiagnosed immune problems. Finally, parents or legal guardians must give their permission for their child to take part.

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 3 months and 16 years old?
Is your child in intensive care for a severe infection?
Is their infection severe enough to require hospital care for over 24 hours?
Does your child NOT have a previously known immune condition or other health problem that explains their illness?
Are you able to give permission for your child to join the study?

Answer every question to see your result.

What does participation involve?

The study does not specify particular visits, assessments, or medication from the study itself. It focuses on collecting information from children who are already in intensive care for a severe infection. This likely involves reviewing their medical records and potentially taking extra blood or tissue samples from those already being collected for their care, to look for signs of an immune deficiency. The total duration of involvement wouldn't extend beyond their hospital stay for the severe infection, but follow-up on results might occur after discharge. Specific details about what participating involves would be fully explained by the study team if it's considered for your child.

Potential risks and benefits

Potential benefits for children taking part include the possibility of identifying an underlying immune problem that might not have been found otherwise, which could lead to more tailored care or advice for future health. However, there are no direct health benefits guaranteed from simply being in the study. While specific risks like additional tests are not detailed, any blood or tissue samples would likely be taken as part of routine medical care to minimise extra procedures. There's always a small risk of discomfort or bruising from blood tests. You and your child have the right to withdraw from the study at any time without it affecting their medical care.

Locations (1)

Uhmontpellier
Verified postcode
Montpellier, France· Recruiting

Common questions

What is a 'primary immune deficiency'?

It's when a child is born with an immune system (their body's defence against germs) that doesn't work as well as it should, making them more prone to serious infections.

Why is this study important?

It aims to understand if hidden immune problems contribute to severe infections in children, which could help doctors improve diagnosis and care in the future.

Will my child receive any new treatments in this study?

No, this study is observational, meaning it collects information and samples; it doesn't test new treatments or medications.

Who is paying for this study?

The study document does not specify the funding source.

Can I change my mind about my child participating?

Yes, you can withdraw your child from the study at any time, and it will not affect their medical care.

How to find out more

Eric JEZIORSKI

e-jeziorski@chu-montpellier.fr 04 67 33 57 98 Official trial record

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