Active not recruitingOBSERVATIONAL

Metagenomic Next-Generation Sequencing for the Diagnosis of Fracture-related Infection

This research is investigating a new and advanced way to detect infections that occur after a bone breaks, known as fracture-related infections (FRI). Currently, infections are diagnosed using standard lab tests, but sometimes these don't identify the cause. This study uses a new DNA sequencing technology called 'metagenomic sequencing' (specifically, Nanopore technology). This technique can rapidly identify all the different types of tiny germs (like bacteria) present in a sample. Researchers will test bone samples from patients with FRI using this new method and compare the results to traditional tests. The main goal is to see if this advanced DNA test can offer a more accurate and helpful way to diagnose FRI.

At a glance

Status

Active not recruiting

Sponsor

Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer

Enrolment target

100

Start

11 Mar 2024

Estimated completion

31 Dec 2025

Infection Fracture Bone

What is this study about?

Imagine you've broken a bone, and unfortunately, an infection develops where the bone broke. These 'fracture-related infections' (FRI) can be challenging to treat. Doctors need to know exactly what kind of germ is causing the infection to pick the right medicine. Sometimes, our current tests don't always find the germ, which can make treatment harder.

This study is trying out a clever new type of test called 'metagenomic sequencing,' which uses something called Nanopore technology. Think of it like a super-smart detective test for germs. Instead of just looking for common culprits, this test can quickly scan all the DNA in a sample and identify every single germ that might be hiding there, even rare ones or those that are hard to grow in the lab. This could give doctors a much clearer picture of what's causing the infection.

The main idea is to see if this advanced DNA test is better than the usual tests we use now. Researchers will take bone samples from patients who have a fracture-related infection and test them using both the new DNA method and the standard methods. By comparing the results, they hope to show that this new technology could become a valuable tool for helping doctors quickly and accurately diagnose and treat these tricky infections.

Key takeaways

This study evaluates a new, advanced DNA test for bone infections.
It uses a small part of a sample already being taken for your care.
No extra tests or procedures are involved for you.
The goal is to improve how fracture-related infections are diagnosed in the future.
Your participation helps advance medical science with no direct risks to you.

Who may be eligible?

To be part of this study, you need to be at least 18 years old. You must have been diagnosed with a fracture-related infection (FRI), which means an infection where a bone has broken.

Crucially, you would already be scheduled to have a small operation to take a bone or soft tissue sample as part of your usual medical care to help diagnose or treat your infection. This study will use a tiny part of that sample.

There are a few reasons why you couldn't join. If you don't want to participate, that's perfectly fine. Also, if you are under any kind of legal protection that affects your ability to make your own decisions about medical research, you wouldn't be able 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.

Are you 18 years old or older?
Have you been diagnosed with an infection where your bone broke?
Are you already scheduled to have a bone or soft tissue sample taken as part of your usual care?
Are you able to provide your own consent to participate?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you won't have any extra appointments or procedures beyond what your doctors have already planned for you. The study simply uses a small part of a tissue sample that would already be taken during your routine care to help diagnose your infection. There are no extra visits, medical assessments, or medications involved with this study. The total duration of your participation only involves the analysis of this single sample.

Potential risks and benefits

The main benefit of this study is that it doesn't involve any extra procedures for you. It uses a sample that you're already giving for your routine medical care. By contributing to this research, you'll be helping doctors learn if a new, advanced test could improve how fracture-related infections are diagnosed in the future, potentially leading to better care for others. There are essentially no direct risks to you as a participant because no additional medical interventions or changes to your care are involved. You have the full right to decide not to participate or to withdraw your consent at any time without affecting your medical treatment.

Locations (2)

IHU, service des maladies infectieuses chroniques
Verified postcode
Marseille, France
Military Teaching Hospital Sainte Anne
Verified postcode
Toulon, France

Common questions

What is a fracture-related infection?

It's an infection that happens in the area where a bone has been broken, often near surgical implants used to fix the break.

What is 'metagenomic sequencing'?

It's an advanced DNA test that can identify all the different types of tiny germs (like bacteria) present in a sample very quickly.

Will I have to have extra tests or operations?

No, you won't need any extra tests or operations. The study uses a small part of a sample already taken for your routine medical care.

Will this study change my medical treatment?

No, this study is for research purposes only and will not change how your doctors treat your infection or your medical care.

What happens to my sample?

A small piece of your bone or tissue sample, which is leftover after your doctors do their routine tests, will be used for the new DNA sequencing technique, always ensuring your privacy is protected.