RecruitingOBSERVATIONAL

Immunosuppression and Intensive Care Unit-acquired Multidrug-resistant Bacteria

This study is for very sick patients in intensive care units (ICUs). Researchers are interested in understanding if people with weakened immune systems, due to illness or treatment, are more or less likely to get serious infections from germs that are resistant to common antibiotics. These resistant germs can make patients stay in the ICU longer and can be harder to treat. Previous research suggested that for patients with weakened immune systems, extra hygiene measures might help prevent them from carrying these resistant germs, but this needs more investigation. This new study aims to observe many patients across different European ICUs to confirm these findings and better understand how infection control steps can reduce the spread of antibiotic-resistant germs in hospitals.

At a glance

Status

Recruiting

Sponsor

University Hospital, Lille

Enrolment target

1,000

Start

19 Mar 2025

Estimated completion

01 Dec 2029

Critically-ill Patients

What is this study about?

This study is about a very important health issue: germs that have become resistant to common antibiotics. These "superbugs" are a growing concern worldwide, and they are especially common in intensive care units (ICUs) where very sick patients are being treated. When patients in an ICU get these resistant germs, it can lead to longer hospital stays and more serious health problems.

Doctors are keen to understand why some patients might be more or less likely to pick up these resistant germs. Of particular interest are patients who have weakened immune systems, perhaps due to cancer, organ transplants, or certain medications. These patients are often more vulnerable to infections.

Recently, a study in France suggested that patients with weakened immune systems in ICUs might actually be less likely to have these resistant germs living in or on their bodies, and this might be because of extra infection control steps taken to protect them. However, they still seemed just as likely to develop actual infections. This new study, called TANGERINE, aims to look at a much larger group of patients across Europe to see if these early findings are true. By doing so, we can learn more about how to best protect very sick patients from these challenging infections and help control the spread of antibiotic resistance.

Key takeaways

This study investigates antibiotic-resistant germs in intensive care units (ICUs).
It focuses on how patients with weakened immune systems might be affected.
The goal is to understand if hygiene rules help prevent germ spread.
No new treatments or tests are given; it's an observational study.
Information gathered could improve future infection control in hospitals.

Who may be eligible?

This study is looking for adults aged 18 or older who are admitted to an intensive care unit (ICU) and will be staying for at least two days. Participants can either have a normal immune system or a weakened one. A weakened immune system might be due to conditions like cancer (currently being treated or in remission for less than 5 years), bone marrow or organ transplants, HIV infection, or certain medications, such as high-dose steroids.

To be included, patients must be receiving certain advanced medical support, like being on a breathing machine or medication to support blood pressure. Also, you must be covered by a social security system. If you're able to, you'll be asked if you're happy to take part. If you're too unwell, a family member or trusted person will be asked on your behalf, and you'll be informed and asked for your consent as soon as you're able.

There are also some reasons why a patient cannot join. These include being under 18, staying in the ICU for less than two days, being too unwell to likely survive, or if routine tests for resistant germs won't be done within the first two days of admission. People who are pregnant, breastfeeding, in prison, or under formal legal protection (like guardianship) also cannot take part, nor can those who refuse to participate or are already in another research 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?
Are you expected to stay in the ICU for more than 48 hours?
Are you currently on a breathing machine or blood pressure support medicine?
Do you have a medical condition that affects your immune system (e.g., cancer, transplant, HIV) or are you receiving treatment that does?
Are you covered by a social security system?

Answer every question to see your result.

What does participation involve?

This is an observational study, which means you won't be given any new treatments or medications just for the study. Instead, researchers will be gathering information from standard tests and procedures that are already part of your usual care in the ICU. This includes information from routine tests for germs and details about your medical condition and care.

There are no extra visits or special assessments required from you. The researchers will simply collect data that is already being recorded during your hospital stay. The duration of your participation will be for the length of your stay in the intensive care unit.

Potential risks and benefits

Because this is an observational study, it does not involve giving you new treatments or changing your medical care. This means there are no direct physical risks to you from taking part. The main benefit is that the information gathered from your care, along with many other patients, will help doctors understand more about how antibiotic-resistant germs spread in hospitals. This knowledge could lead to better ways of preventing and treating these serious infections in the future, improving care for many others. You are free to withdraw from the study at any time without affecting your medical care.

Locations (1)

chu de Lille
Verified postcode
Lille, France· Recruiting

Common questions

What is an 'observational study'?

An observational study means doctors watch and collect information about your usual medical care. You won't get any extra treatments or tests just for the study.

Why is this study important for people with weakened immune systems?

People with weakened immune systems can be very vulnerable to infections. This study hopes to find the best ways to protect them from serious antibiotic-resistant germs in the hospital.

Will I receive any new medicine by participating?

No, this study does not involve giving you any new medicines or treatments. Researchers will only collect information from your standard care.

What are 'multidrug-resistant bacteria'?

These are germs that have become resistant to several common antibiotics, making them harder to treat with standard medicines.

Can I stop participating if I change my mind?

Yes, you or your legal representative can decide to stop your participation at any time, and this will not affect your medical care.

How to find out more

Saad NSEIR, Professor

saadalla.nseir@chu-lille.fr 33 (0)3 20 44 44 95 Official trial record

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