RecruitingNAINTERVENTIONAL

Diagnostic of D-lactate in Cerebrospinal Fluid Level in Patients With Suspected Ventriculostomy-related Meningitis

This study, called TOTEM, is being done in one hospital to find a better way to diagnose a serious brain infection called meningitis. This type of meningitis can happen in patients who have a special tube called a ventriculostomy in their brain, often after surgery. Doctors suspect meningitis when patients get a fever, headache, or become confused, without another clear reason. The research will check for a specific chemical, D-lactate, in the fluid around the brain and spinal cord (spinal fluid). By comparing these levels with other signs of infection, researchers hope to see if D-lactate testing can help diagnose this infection more quickly and accurately. This could lead to faster treatment for patients.

At a glance

Status

Recruiting

Phase

Sponsor

University Hospital, Toulouse

Enrolment target

185

Start

12 Feb 2025

Estimated completion

01 Feb 2027

Nosocomial Infection

What is this study about?

This study is investigating a new way to diagnose a serious brain infection called meningitis, specifically in patients who have a device called a ventriculostomy. A ventriculostomy is a thin tube surgeons place into the fluid-filled spaces of the brain (ventricles) to help drain fluid or measure pressure. While very helpful, sometimes these tubes can unintentionally lead to infections, known as 'ventriculostomy-related meningitis'. Diagnosing this infection quickly is crucial for effective treatment and patient recovery.

The usual methods to diagnose meningitis can sometimes take time. This study is exploring if a chemical called D-lactate, found in the fluid around the brain and spinal cord (cerebrospinal fluid or CSF), could be a faster and more reliable sign of this type of infection. Researchers will collect small samples of CSF from patients who are already having a ventriculostomy and are suspected of having meningitis. They will then test these samples for D-lactate, alongside other markers of infection.

The goal is to see if measuring D-lactate can help doctors make a more accurate diagnosis sooner. This could mean patients get the right treatment faster, which is very important for brain infections. The information gathered from this study could improve how doctors diagnose and manage this condition in the future.

Key takeaways

This study aims to find a faster way to diagnose brain infections.
It focuses on patients with a brain drain tube (ventriculostomy).
Researchers are testing a chemical called D-lactate in spinal fluid.
Participation involves only using leftover samples from routine medical checks.
There are no additional medical procedures or treatments involved for you.
The study hopes to improve diagnosis of meningitis for future patients.

Who may be eligible?

This study is looking for adults aged 18 or over who are currently in Toulouse University Hospital and have a ventriculostomy (a special tube in their brain). You might be considered if your doctors suspect you have a hospital-acquired brain infection (meningitis) because you have symptoms like a fever, headache, feeling confused, or changes in your usual behaviour, and there isn't another obvious reason for these symptoms.

There are also some reasons why you wouldn't be able to join. For instance, if you've recently had a different type of meningitis or a similar brain infection, or if you're taking part in another research study that prevents you from joining this one. They also cannot include pregnant or breastfeeding women, or individuals who are under legal guardianship.

Some specific health conditions, like certain severe kidney problems or issues with your digestive system, would also mean you couldn't participate. You'll need to be able to understand the study information and agree to take part verbally before joining.

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?
Do you currently have a ventriculostomy placed at Toulouse University Hospital?
Are your doctors concerned you might have a brain infection (meningitis)?
Are you not pregnant or breastfeeding?
Are you able to verbally agree to take part after hearing about the study?
Have you not had a recent brain infection (meningitis) in the last month?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you won't need to do anything extra regarding your treatment, as it's observational. When doctors typically take a sample of your spinal fluid (from your ventriculostomy tube) to check for infection as part of your routine care, an extra small sample will be taken at the same time and saved for this research. This won't involve any additional procedures for you.

These samples will be carefully stored and later tested for D-lactate and other infection markers. If the first sample doesn't show signs of meningitis, another routine sample might be taken a few days later, again as part of your regular medical checks, if needed to reassess your condition. The study team will then review your medical records over the next four weeks. This review helps the researchers confirm whether you had meningitis or not, based on all the information available to your doctors. No follow-up visits are required specifically for the study after you leave the hospital, as the information is gathered from your existing medical records.

Potential risks and benefits

Since this study only involves taking an extra small sample from a procedure you're already having and reviewing your medical records, there are no extra risks beyond what you would normally experience with your medical care. You won't receive any new treatments or experience any additional procedures. While there's no direct personal benefit to you, your participation could help doctors learn more about diagnosing brain infections, potentially leading to better care for future patients. You are free to decide not to participate or to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Toulouse Hospital
Verified postcode
Toulouse, France· Recruiting

Common questions

What is a ventriculostomy?

It's a small tube placed in the brain, often to drain fluid or measure pressure.

What is meningitis?

Meningitis is a serious infection of the protective membranes surrounding the brain and spinal cord.

What is D-lactate and why is it important?

D-lactate is a chemical that might be a quick sign of a brain infection, helping doctors diagnose it faster.

Will taking part affect my medical treatment?

No, this study only involves taking an extra sample from a procedure you're already having and reviewing your records; it won't change your medical care.

Do I have to do anything special for this study?

No, you don't need to do anything extra. Samples are taken during your routine care, and your existing medical records are reviewed.

How to find out more

Lucie LELIEVRE, Md

lelievre.l@chu-toulouse.fr 0561777198 Official trial record

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