RecruitingNAINTERVENTIONAL

Biomarker Signature-Supported Antibiotic Treatment Decisions in ICU

This study, taking place in an Intensive Care Unit (ICU), aims to see if using a special test, called a 'biomarker signature', can guide doctors to use antibiotics more effectively. When people are very ill in the ICU, they often need antibiotics, but using too many or for too long can have downsides. This research wants to find out if this new test can help doctors decide when and for how long to give antibiotics, leading to less antibiotic use without harming patients. Doctors will look at the results of this test alongside their usual medical judgment. The study compares this new approach with standard care, looking at how much antibiotic is used and how well patients recover over about four weeks.

At a glance

Status

Recruiting

Phase

Sponsor

McGill University Health Centre/Research Institute of the McGill University Health Centre

Enrolment target

1,200

Start

13 May 2025

Estimated completion

01 Aug 2028

Intensive Care Unit (ICU) Admission

What is this study about?

When you're very ill and in an Intensive Care Unit (ICU), antibiotics are often a vital part of your treatment. They help fight serious infections. However, using antibiotics unwisely can lead to problems like antibiotic resistance, which means the medicines might stop working as well in the future. It’s also important not to use antibiotics if they're not truly needed, or to stop them when they’ve done their job.

This study is trying to find a better way for doctors to decide about antibiotics. They are testing a new approach that uses a special medical test, sometimes called a 'biomarker signature'. This test gives doctors extra information that, combined with their normal medical checks, could help them make more informed choices about when to start, continue, or stop antibiotics. The main aim is to see if this new approach can reduce the amount of antibiotics people receive, without making them any sicker or affecting their recovery.

Researchers will compare two groups of patients: one group will have their antibiotic decisions guided by this new test alongside their doctor's judgment, while the other group will receive antibiotics based on standard care. By looking at both how many antibiotics are used and how well patients recover, the study hopes to show whether this new method offers a safer and more effective way to manage infections in the ICU.

Key takeaways

A study for very ill patients in the ICU.
Aims to improve antibiotic use with a new test.
Could help reduce unnecessary antibiotic exposure.
Compares a new test-guided approach to standard care.
Focuses on patient safety and recovery over 4 weeks.

Who may be eligible?

To join this study, you would need to be an adult (18 or over) who has recently been admitted to the Intensive Care Unit (ICU). You would also have started taking antibiotics in the last three days because doctors suspect or have confirmed an infection. Importantly, the doctors looking after you must be open to considering the results of the special test when making decisions about your antibiotics.

However, there are certain situations where you wouldn't be able to join. For example, if your immune system is severely weakened due to certain conditions or treatments, like specific types of cancer treatment or serious immune diseases. Also, if your doctors believe you are sadly nearing the end of your life within the next four weeks, or if you've already been treated for an infection with antibiotics in the last two weeks as part of the same hospital stay, you wouldn't be eligible.

Additionally, if the antibiotics you're taking are only meant for a very short time (less than 24 hours) as a preventative measure, or if you have widespread advanced cancer, this study might not be suitable for you.

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 currently in the ICU?
Have you started antibiotics for a suspected infection in the last 3 days?
Is your medical team willing to consider new test results for your treatment?
Is your immune system strong enough (not severely weakened by certain conditions)?
Are you not receiving short-term 'preventative' antibiotics (less than 24 hours)?

Answer every question to see your result.

What does participation involve?

If you join this study, you will be assigned by chance (like flipping a coin) to one of two groups. In one group, your doctors will use the results of the special biomarker test, along with their usual medical examination, to decide on your antibiotic treatment. In the other group, your doctors will make decisions about your antibiotics in the usual way, without using the new test.

The study will mainly involve observing your treatment and recovery in the ICU. There won't be any new medicines given specifically for this study, nor will there be extra visits or scans beyond what your medical team already plans for your care. Researchers will collect information from your existing medical records, focusing on how many antibiotics you receive and how your health improves, for about four weeks after you join the study. The total duration of your involvement will be around 28 days.

Potential risks and benefits

A potential benefit of taking part in this study is that the new approach, if successful, could lead to more precise use of antibiotics. This might mean you receive fewer antibiotics, which could reduce the risk of side effects and help generally reduce antibiotic resistance. There are no direct expected risks above those already associated with your care in the ICU, as no new treatments are being given. The study is designed to ensure that your safety and well-being are the top priority. Please remember that participating is entirely voluntary, and you are free to withdraw from the study at any time without it affecting your medical care.

Locations (4)

Montreal General Hospital
Verified postcode
Montreal, Canada· Recruiting
Research Institute of McGill University Health Center (RI-MUHC)
Verified postcode
Montreal, Canada· Recruiting
Royal Victoria Hospital
Verified postcode
Montreal, Canada· Recruiting
Research Institute McGill University Health Centre
Verified postcode
Montreal, Canada· Recruiting

Common questions

What is an Intensive Care Unit (ICU)?

The ICU is a special hospital ward for people who are very seriously ill and need constant monitoring and treatment.

What is a 'biomarker signature'?

It's a special medical test that looks for signs in your body to give doctors extra information about your infection and how best to treat it.

Will I get different medical care if I'm in the study?

Your doctors will always provide the best care for you. This study just looks at how different information (from the biomarker test) might help them make choices about antibiotics.

Will I have to take any new medicines?

No, you won't be given any new medicines specifically because of this study. It's about how existing antibiotics are managed.

How long will I be in the study?

The study will observe your treatment and recovery for about four weeks after you join.

How to find out more

Makeda Semret, MD

makeda.semret@mcgill.ca 15149341934 Official trial record

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