RecruitingNAINTERVENTIONAL

Metagenomic Sequencing for the Identification of Pathogens in Febrile Neutropenic Patients

When people with cancer, especially those having strong treatments like chemotherapy, get a fever and low white blood cells (a condition called febrile neutropenia), it can be dangerous. This is because their weakened immune system struggles to fight off infections. Doctors need to find out quickly what germ is causing the infection to give the best treatment. We're testing a new method called mNGS-DISQVER. This tool aims to find different types of germs like bacteria, viruses, or fungi from a blood sample faster and more accurately than current tests. The goal is to see if this new test can help doctors make better decisions about treatment, potentially improving recovery for these high-risk patients.

At a glance

Status

Recruiting

Phase

Sponsor

Poitiers University Hospital

Enrolment target

200

Start

12 Jan 2024

Estimated completion

12 Jan 2025

Immunodepressed Patients (Hemato-oncology)

What is this study about?

When you're undergoing strong cancer treatments, your body's ability to fight off infections, known as your immune system, can become weaker. This can lead to a condition called 'febrile neutropenia', which means you have a fever and a very low number of certain white blood cells (neutrophils) that help fight germs. This is a serious condition because even common germs can cause severe illness when your immune system is weak.

Currently, when you get febrile neutropenia, doctors try to find the germ causing the infection using tests like blood cultures. However, these tests can sometimes be slow or not find the germ at all. This means doctors have to start treatment based on what they think is most likely, and sometimes precious time is lost, or the treatment isn't perfectly tailored to the germ causing the problem.

This study is looking at a new, advanced blood test called mNGS-DISQVER. Imagine it like a very comprehensive detective that can look for many different types of germs – bacteria, viruses, fungi, and more – all at once from a single blood sample. The main goal is to see if this new test can identify these germs faster and more effectively than the usual tests. If it can, it might help doctors pinpoint the exact infection earlier, leading to more targeted and effective treatment for people with febrile neutropenia, potentially improving their recovery.

Key takeaways

New test (mNGS-DISQVER) for infection in cancer patients.
Aims to find germs quicker and more accurately.
Focuses on serious fevers with low white blood cells (febrile neutropenia).
May lead to better-matched treatments in the future.
Your current medical care will not be changed by taking part.

Who may be eligible?

To join this study, you need to be an adult (18 years or older) who is currently being treated for cancer (either solid tumours or blood cancers). You must also have a specific type of serious fever and low white blood cell count called 'high-risk febrile neutropenia,' which is defined by certain scores and expected to last at least seven days. You'll need to be able to understand what the study involves and agree to take part freely.

However, you won't be able to join if you've had antibiotics (apart from certain preventative ones) in the 24 hours before signing up, or if you've already been part of a similar study. Also, if you're pregnant, breastfeeding, or of childbearing age and not using effective contraception, you cannot take part. We also can't include minors or adults under legal protection.

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.

Are you 18 years old or older?
Are you currently having cancer treatment (for solid tumour or blood cancer)?
Have your doctors told you that you have 'high-risk febrile neutropenia'?
Have you *not* taken antibiotics (other than preventative ones) in the last 24 hours?
Are you not pregnant or breastfeeding, and if you could get pregnant, are you using effective contraception?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, the main involvement will be providing blood samples. These samples will be used to test the new mNGS-DISQVER method, comparing its results with the standard tests your doctors are already doing. The study will not change how your doctors manage your febrile neutropenia initially, as they will still base your immediate treatment on current best practices. The new test is being evaluated to see if it could improve future care. There are no specific study medications involved, and your follow-up will be as per your usual medical care. The exact total duration of your participation will depend on your hospital stay and condition, but primarily focuses on the initial diagnosis episode.

Potential risks and benefits

Participating in this study might offer the benefit of helping to improve future diagnosis and treatment for patients like yourself, even if it doesn't directly change your immediate care. The main risk involves providing an extra blood sample, which carries the small usual risks associated with blood draws, such as slight bruising or discomfort. You are free to withdraw from the study at any time without giving a reason, and this will not affect your medical care.

Locations (5)

C.H.U. d'Angers
Verified postcode
Angers, France· Recruiting
CHU de Brest
Verified postcode
Brest, France· Recruiting
C.H.U. de Limoges
Verified postcode
Limoges, France· Not yet recruiting
C.H.U. de Poitiers
Verified postcode
Poitiers, France· Recruiting
C.H.U. de Tours
Verified postcode
Tours, France· Recruiting

Common questions

What is 'febrile neutropenia'?

It's a serious condition in cancer patients where they have a fever and a very low number of white blood cells, making them vulnerable to infections.

What is mNGS-DISQVER?

It's a new, advanced blood test designed to quickly identify various germs (bacteria, viruses, fungi) that might be causing an infection.

Will this study change my current treatment?

No, your doctors will continue to treat you based on their usual practice. This study is evaluating a new test for future care improvements.

Do I have to pay to participate?

No, you don't have to pay to participate. The study costs are covered, and you must be covered by a social security scheme.

Can I leave the study at any time?

Yes, you can withdraw from the study at any point, and it won't affect your medical care or relationship with your doctors.

How to find out more

Maxime PICHON

maxime.pichon@chu-poitiers.fr +33 5.49.44.41.43 Official trial record

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