RecruitingOBSERVATIONAL

Rectal Carriage of Carbapenemase Producing-Enterobacteriaceae on Admission to a French University Teaching Hospital

This study is happening in a large hospital in France to understand more about certain types of "superbugs" called CPE (carbapenemase-producing Enterobacteriaceae). These germs can be very difficult to treat because many antibiotics don't work against them. The researchers want to find out how many patients carry these germs when they first come into the hospital, even if they don't feel sick. They also want to identify what factors might make someone more likely to carry these germs. The main goal is to find better ways to stop these germs from spreading in hospitals and to make sure patients get the right treatment if they have a serious infection.

At a glance

Status

Recruiting

Sponsor

Assistance Publique - Hôpitaux de Paris

Enrolment target

1,195

Start

03 Apr 2023

Estimated completion

31 Dec 2026

Rectal Carriage of Carbapenemase Producing-Enterobacteriaceae

What is this study about?

Imagine tiny germs, called bacteria, that live in and on our bodies. Most of the time, they're harmless or even helpful. But sometimes, some bacteria learn to fight off the medicines (antibiotics) we use to kill them. These are often called "superbugs." This study is focusing on a particular type of superbug known as CPE (carbapenemase-producing Enterobacteriaceae). These CPE germs are a growing concern because they can be very difficult to treat if they cause a serious infection, as many common antibiotics no longer work against them.

Doctors and researchers want to understand how common it is for people to carry these CPE germs when they are first admitted to a hospital. Sometimes, people can carry these germs without feeling sick themselves, but they could potentially spread them to others. Pinpointing how many people carry them and what might put someone at higher risk of carrying them is crucial. This information can help hospitals develop better strategies to prevent these germs from spreading, especially to patients who are already unwell. It can also help doctors decide on the best treatment more quickly if a patient carrying these germs develops a severe infection.

To find this out, the study team at a hospital in France will be asking a group of adult patients, who have recently been admitted, if they would be willing to take part. For those who agree, a simple swab will be taken from their bottom (a rectal swab) to check for these specific germs. The researchers will also ask some questions about the patient's health history, where they've lived or travelled, and any recent antibiotic use. All of this information will help them understand the bigger picture: how widely these germs are spread, why some people might carry them, and how hospitals can better protect patients in the future.

Key takeaways

The study helps understand how 'superbugs' spread in hospitals.
It aims to find out how many patients carry these germs when admitted.
Participation involves a questionnaire and a simple swab from your bottom.
It could lead to better ways to prevent infections and guide treatments.
Your involvement is voluntary and won't affect your medical care.

Who may be eligible?

To be part of this study, you need to be at least 18 years old. You must have been admitted to a medical, surgical, maternity, or intensive care unit at the Bichat-Claude Bernard Hospital in Paris within the last three days. Importantly, you also need to agree to take part in the study.

There are some reasons why you wouldn't be able to join. For example, if you were admitted to the hospital more than three days ago, or if you're returning to the same ward shortly after being discharged, you wouldn't be eligible. Also, if you're staying in a rehabilitation or long-term care unit, or if you don't have social security coverage in France, you wouldn't be able to participate. Finally, anyone under legal protection (like someone with a guardian) cannot join this study.

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 admitted to the Bichat-Claude Bernard Hospital within the last 3 days?
Are you currently in a medical, surgical, maternity, or intensive care unit?
Are you happy to take part in the study?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, it would involve a few simple steps. First, you'd be asked to answer some questions about your health, any past travel, and medicines you've taken, either through a questionnaire or by looking at your medical records. Around the same time, a healthcare professional would take a small, quick swab from your bottom (a rectal swab). This swab helps check for the germs the study is interested in. There are no extra hospital visits required beyond your normal hospital stay. The study involves a one-off collection of information and a swab at the time of your admission. The total duration of your direct involvement would be very short – just the time it takes to answer questions and have the swab taken.

Potential risks and benefits

Taking part in this study might offer some potential personal benefits, such as contributing to a better understanding of how superbugs spread, which could lead to improved hospital care for everyone in the future. For you specifically, if superbugs are found, your healthcare team might be more aware and better prepared to treat you if you do get a serious infection. The risks involved are very low; the rectal swab is quick and generally not painful, though it might be slightly uncomfortable for a moment. All your personal information will be kept strictly private and anonymous. You are absolutely free to decide not to participate at any point, and this will not affect your care in any way.

Locations (1)

Bichat Hospital
Verified postcode
Paris, France· Recruiting

Common questions

What are CPE superbugs?

CPE stands for carbapenemase-producing Enterobacteriaceae. These are types of bacteria (germs) that have become resistant to many common antibiotics, making them harder to treat if they cause an infection.

Why is this study important?

This study aims to understand how many people carry these superbugs when they come to the hospital and why. This information will help hospitals stop the germs from spreading and improve treatment for patients who might become sick.

Will I feel sick if I have these superbugs?

Not necessarily. Many people can carry these superbugs in their gut without feeling sick themselves. However, they could potentially spread them to others, or these germs could cause an infection if your immune system is weak.

What does a 'rectal swab' involve?

A rectal swab is a quick and simple procedure where a cotton bud is gently rubbed just inside your bottom to collect a small sample. It's usually not painful, just a little uncomfortable.

Will I be told my results?

The study description doesn't specifically say whether individual patients will be informed of their swab results. You should ask the study team or your doctor about this if you are considering participating.

How to find out more

Solen Kernéis, MD - PhD

solen.kerneis@aphp.fr 33140256199 Official trial record

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