RecruitingPHASE4INTERVENTIONAL

Dabigatran vs. Oral Anti-Xa Inhibitors in S. Aureus Bacteremia

This study is looking at people who have a serious blood infection caused by a germ called S. aureus (Staphylococcus aureus). These patients are already taking certain blood-thinning medicines (Apixaban, Edoxaban, or Rivaroxaban) for conditions like preventing strokes or treating blood clots. We want to find out if changing their blood thinner to a different one called dabigatran could help them get better. Dabigatran has shown some signs of fighting S. aureus in lab tests, and this study aims to see if that works in real patients. It's a key part of a larger research effort to improve treatments for S. aureus infections, especially for those who already need blood thinners.

At a glance

Status

Recruiting

Phase

PHASE4

Sponsor

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

Enrolment target

300

Start

15 Jan 2026

Estimated completion

01 Jan 2030

Staphylococcus Aureus Endocarditis Staphylococcus Aureus Septicemia Staphylococcus Aureus Bacteremia Staphylococcus Aureus Bloodstream Infection S. Aureus Bacteremia S. Aureus Bloodstream Infection

What is this study about?

Imagine you have a serious blood infection called S. aureus bacteremia, caused by a common germ. Many people with this infection also need blood-thinning medicines for other health issues, like preventing strokes if they have an irregular heartbeat (atrial fibrillation) or treating blood clots in their legs or lungs. This study aims to see if one particular blood-thinning medicine, called dabigatran, could offer a double benefit by not only helping with blood clots but also fighting the S. aureus infection itself.

Researchers have noticed that dabigatran might have germ-fighting properties against S. aureus in lab dishes and animal studies. This trial will explore whether these promising signs translate into better results for patients. If you're already taking a blood thinner like apixaban, edoxaban, or rivaroxaban and develop an S. aureus blood infection, doctors in this study might suggest staying on your current medication or switching to dabigatran. This is a very important step to understand if dabigatran could be a more effective treatment option for this specific group of patients.

This research is part of a larger project called The Staphylococcus aureus Network Adaptive Platform (SNAP) trial. By carefully comparing these medicines, the study hopes to find new ways to improve care for people with S. aureus infections who also need blood thinners. The information learned from this study could even lead to further research about dabigatran for people who don't currently need blood thinners but have S. aureus infections.

Key takeaways

This study compares different blood thinners for a serious S. aureus blood infection.
It's for people already taking blood thinners for approved medical reasons.
Dabigatran is being investigated for its possible dual benefit: blood thinning and fighting infection.
Participation involves either continuing your current blood thinner or switching to dabigatran.
This research aims to improve treatment for S. aureus infections.
It's part of a larger ongoing research programme for S. aureus.

Who may be eligible?

This study is for adults aged 18 and over, of any gender. To join, you need to have an S. aureus blood infection and already be taking a specific type of blood-thinning medicine, such as Eliquis (apixaban), Lixiana (edoxaban), or Xarelto (rivaroxaban). You must be taking this medicine for an approved reason, like preventing a stroke if you have atrial fibrillation, or for treating or preventing blood clots (deep vein thrombosis or pulmonary embolism). If you've recently had hip or knee replacement surgery, you might also be eligible if you're taking these medicines to prevent clots and have at least 30 days of treatment remaining.

However, there are some reasons why you wouldn't be able to join. You can't participate if you're currently bleeding a lot or are expected to have major heart, brain, or spinal surgery in the next three days. If you're pregnant, have a known allergy to dabigatran, or have taken dabigatran in the last month, you're also not eligible. The study also cannot include individuals with very poor kidney function or those taking certain other medications that could interact significantly with the study drugs. Additionally, if you're using blood thinners for reasons not officially approved, that would also exclude 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?
Do you have a Staphylococcus aureus blood infection?
Are you currently taking apixaban, edoxaban, or rivaroxaban for stroke prevention or blood clot treatment?
Are you free from severe bleeding or recent major surgery plans?
Are you not pregnant and don't have severe kidney problems?
Are you not allergic to dabigatran and haven't taken it recently?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you might be asked to continue with your current blood-thinning medication or switch to dabigatran. Which medicine you receive will be decided randomly, like flipping a coin. You will have regular check-ups and blood tests to monitor your health and how the medication is working. You will be closely monitored for any side effects or changes in your condition. The exact number of visits and tests will be explained in detail by the study team. This study is an important part of your overall care, and the study team will keep you informed every step of the way.

Potential risks and benefits

Taking part in this study could potentially offer a benefit if dabigatran is found to be more effective at treating your S. aureus infection while also managing your blood clot risk. However, there are also potential risks, as with any medication, including potential side effects from dabigatran or from changing your current medication. The study team will carefully monitor you for any problems. You will receive detailed information about all possible risks and benefits before deciding to join, and you are free to withdraw from the study at any time without affecting your medical care.

Locations (1)

McGill University Health Centre (Royal Victoria Hospital and Montreal General Hospital)
Verified postcode
Montreal, Canada· Recruiting

Common questions

What is S. aureus bacteremia?

It's a serious blood infection caused by a common germ called Staphylococcus aureus.

What are blood thinners, and why are they used?

Blood thinners are medicines that help prevent blood clots. They're used for conditions like preventing strokes or treating clots in veins or lungs.

What's the main goal of this study?

The study aims to see if dabigatran, a type of blood thinner, can also help fight S. aureus infections in people who need blood thinners.

Will I get to choose which medicine I receive?

No, if you join, the medicine you receive (either your current one or dabigatran) will be chosen randomly, like drawing lots.

Can I leave the study if I change my mind?

Yes, you can leave the study at any time, and your decision won't affect your medical care.

How to find out more

Lina Petrella

lina.petrella@muhc.mcgill.ca 514-934-1934 Official trial record

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