RecruitingOBSERVATIONAL

Use of a New Method for the Microbiological Diagnosis of Severe Corneal Infection

This study is investigating a new, quicker way to diagnose severe eye infections, specifically those affecting the clear front part of your eye called the cornea. These infections can be very serious and sometimes lead to blindness, often requiring long hospital stays. Currently, finding out exactly what germ is causing the infection can take several days, which means treatment might not be perfectly targeted at first. Researchers are testing a new system called FilmArray PCR, which can identify many different germs in about 75 minutes. They want to see if this faster test can help doctors choose the best treatment sooner, improve patients' eyesight in the long run, and potentially shorten hospital stays and reduce costs. The study will compare this new method with standard testing in patients with severe corneal infections.

At a glance

Status

Recruiting

Sponsor

CHU de Reims

Enrolment target

Start

07 Jul 2023

Estimated completion

07 Aug 2027

Infectious Keratitis Microbial Keratitis Corneal Infection

What is this study about?

Imagine you have a really bad eye infection. Doctors need to find out exactly what germ is causing it so they can give you the right medicine. Right now, this can take a few days, meaning you might be in hospital longer until they pinpoint the problem. This study is all about trying to make that process much faster.

They're looking at a new type of test called FilmArray PCR. Think of it like a very clever detective that can quickly scan for many different types of germs (like bacteria, fungi, or viruses) all at once, in just over an hour. Doctors hope that by using this fast test, they can identify the cause of severe eye infections much more quickly. This means patients could get the most effective treatment sooner, which might help protect their eyesight, reduce how long they need to stay in hospital, and potentially lower overall costs for their care.

To see if this new test works better, doctors will compare it to the usual methods of finding germs in patients with serious eye infections. They'll be looking to see if the new test is more efficient and if it helps patients get better outcomes. This research could change how eye infections are diagnosed and treated in the future, making care quicker and more effective for people with severe corneal infections.

Key takeaways

The study explores a new, faster way to diagnose serious eye infections.
It aims to identify infection causes quicker to provide targeted treatment sooner.
This could improve eyesight and reduce hospital time for patients.
The new test (FilmArray PCR) is compared against standard diagnostic methods.
Participation involves an extra, small eye swab during your hospital stay.
No new medications are given; treatment decisions remain with your doctors.

Who may be eligible?

To join this study, you need to be an adult, aged 18 or over. You also need to be covered by the French social security system and be willing to take part. The most important medical requirement is that you have been admitted to the hospital with a severe corneal infection.

There are some reasons why you couldn't be part of the study. For example, if you've already started taking antibiotics or other treatments for your eye infection within 48 hours before the eye samples are taken, you wouldn't be able to join. Also, if you're not able to give your informed consent (meaning you can't understand and agree to participate in the study), you wouldn't be eligible.

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 covered by French social security?
Are you currently in hospital with a severe corneal (eye) infection?
Have you *not* started antibiotics or other eye infection treatments in the last 48 hours?
Can you understand information about the study and agree to take part?

Answer every question to see your result.

What does participation involve?

If you take part in this study, you will already be in hospital for a severe eye infection. In addition to the usual eye swabs and tests your doctors would normally take to find out what's causing your infection, an extra small sample will be taken from your eye. This extra sample will be used for the new quick test (FilmArray PCR). You will have a full eye examination as part of your standard care. The study aims to compare the results of the new test with standard tests, using information gathered during your hospital stay for your infection. There are no additional visits or follow-up appointments specifically for this study beyond what's needed for your current treatment.

Potential risks and benefits

A potential benefit of this study is that it could help develop a faster and more effective way to diagnose severe eye infections in the future, which might lead to better eyesight and shorter hospital stays for patients. For you directly, there are no immediate risks beyond the discomfort of the routine eye swab you would already have for diagnosis, as only an additional, small sample is collected. There are no new medications involved. You are free to withdraw from the study at any time without affecting your medical care.

Locations (1)

Damien JOLLY
Verified postcode
Reims, France· Recruiting

Common questions

What is a corneal infection?

A corneal infection is a serious infection on the clear front surface of your eye, called the cornea. It can be caused by different germs like bacteria or viruses.

What is the new test called FilmArray PCR?

FilmArray PCR is a fast test that can quickly identify many different types of germs that might be causing an infection, all from a single sample.

Will I get different treatment if I'm in this study?

No, your treatment will be decided by your doctors based on your condition and the standard diagnostic tests. This study is comparing a new test method with existing ones.

How long will I be in the study?

Your participation in the study largely aligns with your hospital stay for your eye infection. There are no extra appointments or follow-up visits specifically for the study.

Will the study results affect my personal care?

The study aims to improve future care for patients with similar conditions. Your immediate care will follow standard medical practice based on your doctors' assessment.

How to find out more

Alexandre DENOYER

adenoyer@chu-reims.fr 03 26 78 78 88 Official trial record

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