A Phase 4 interventional study of Dabigatran and Apixaban in Staphylococcus Aureus Endocarditis, Staphylococcus Aureus Septicemia and Staphylococcus Aureus Bacteremia, sponsored by McGill University Health Centre/Research Institute of the McGill University Health Centre. Recruiting at 3 sites in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-24.
Sponsored by McGill University Health Centre/Research Institute of the McGill University Health Centre · Phase 4, Interventional, and Treatment
This is an open-label randomized controlled trial which will enroll patients with S. aureus bacteremia who are already taking oral anticoagulant medications (apixaban, edoxaban, or rivaroxaban) for an approved indication (stroke prevention in atrial fibrillation, prevention or treatment of venous thromboembolism). We will randomize patients to continue their existing medication or change to another medication (dabigatran) which is approved for the original indication.
Dabigatran is approved in many countries for the treatment or prevention of venous thromboembolism or preventing stroke in atrial fibrillation. Unlike the other medications listed above, dabigatran seems to have activity against S. aureus in the test tube, in animal models, and in a smaller randomized controlled trial. We wish to determine if changing to dabigatran will improve outcomes in S. aureus bacteremia in people who otherwise would have a reason to be taking it.
This study is an approved sub-study of The Staphylococcus aureus Network Adaptive Platform (SNAP) trial (NCT05137119).
If positive, this study will support a second RCT in people who do not currently have an indication for anticoagulation.
297 studies on the registry are indexed under Bacteremia; 51 are open to participants now.
This study's planned enrollment of 300 is above the median of 156 across 156 interventional studies indexed under Bacteremia.
Browse Bacteremia studies →McGill University Health Centre/Research Institute of the McGill University Health Centre is the lead sponsor of 421 studies on the registry; 105 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
The participant must meet all inclusion and exclusion criteria for the SNAP Platform (NCT05137119) and also the following inclusion and exclusion criteria:
Inclusion Criteria:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients will have their anticoagulation changed to dabigatran at the monograph approved dose for the indication, bleeding risk, and renal function.
Drug: Dabigatran
Patients will continue their currently prescribed apixaban, edoxaban, or rivaroxaban
Drug: Apixaban · Drug: edoxaban · Drug: Rivaroxaban
Patients will be assigned to change to dabigatran at the monograph approved dose for their indication, bleeding risk, and renal function.
Patients will continue taking their currently prescribed apixaban, edoxaban, or rivaroxaban
Patients will continue taking their currently prescribed apixaban, edoxaban, or rivaroxaban
Patients will continue taking their currently prescribed apixaban, edoxaban, or rivaroxaban
Desirability of Outcome Ranking (DOOR)
Desirability of Outcome Ranking (DOOR) - an ordinal outcome with 5 levels defined: Rank 1 - Alive without complication Rank 2 - Alive with 1 complication Rank 3 - Alive with 2 complications Rank 4 - Alive with 3 complications Rank 5 - Dead Complications include: 1. Clinical failure: Absence of resolution of clinical signs and symptoms of S. aureus bacteremia such that no additional antibiotic therapy is required or anticipated. 2. Infectious Complications: Including new endocarditis; new evidence of other deep metastatic foci (e.g., osteomyelitis or deep abscess); relapse of MRSA bacteremia after a patient has sterilized their initial blood cultures; readmission for subsequent care of S. aureus bacteremia; need for unplanned source control procedures 3. Serious adverse drug event (Common Terminology Criteria class 4) due to study drug OR adverse drug event (classes 1-3) leading to discontinuation of the study drug
Time frame: Day 90 post enrollment in the S. aureus Network Adaptive Platform Trial (NCT05137119)
Clinical failure
Defined as the absence of resolution of clinical signs and symptoms of S. aureus bacteremia such that no additional antibiotic therapy is required or anticipated for its treatment.
Time frame: Day 90 post enrollment in the S. aureus Network Adaptive Platform Trial (NCT05137119)
Serious Adverse Event or Adverse Event Leading to Discontinuation
Defined as a serious adverse drug event (Common Terminology Criteria for Adverse Events (CTCAE) class 4) presumed due to study drug OR adverse drug event (CTCAE classes 1-3) leading to discontinuation of the study drug
Time frame: Day 90 post enrollment in the S. aureus Network Adaptive Platform Trial (NCT05137119)
All cause mortality
Death from any cause
Time frame: Day 90 post enrollment in the S. aureus Network Adaptive Platform Trial (NCT05137119)
Infectious Complications
Defined as change in therapy for inadequate clinical response; new endocarditis; new evidence of other deep metastatic foci (e.g., osteomyelitis or deep abscess); relapse of MRSA bacteremia after a patient has sterilized their initial blood cultures; readmission for subsequent care of S. aureus bacteremia; need for unplanned source control procedures. New implies that the complication was not suspected at enrollment and is not a function of delay to diagnostic testing.
Time frame: Day 90 post enrollment in the S. aureus Network Adaptive Platform Trial (NCT05137119)
Clinically relevant major bleeding
This will be defined according to the criteria of the International Society on Thrombosis and Haemostasis as one or more of the following: fatal bleeding; symptomatic bleeding in a critical area or organ (including hemorrhagic stroke); bleeding that causes a fall in hemoglobin level of ≥20 g/L; or bleeding that requires a transfusion of 2 or more units of whole blood or red cells. For bleeds into non-critical areas, we will also record the site of bleeding.
Time frame: Day 90 post enrollment in the S. aureus Network Adaptive Platform Trial (NCT05137119)
Clinically relevant venous thromboembolic events
This will be defined as an acute objectively confirmed deep vein thrombosis (upper extremity, lower extremity, other such as portal vein, cerebral vein, splanchnic vein) and/or segment or proximal pulmonary embolism, which is symptomatic and/or necessitates specific treatment. Below knee DVT and superficial thrombophlebitis are not included. Pulmonary embolism needs to be, segmental or proximal. Subsegmental pulmonary embolisms are not included as they have poor interrater reliability and may represent artefact in up to 50% of cases.
Time frame: Day 90 post enrollment in the S. aureus Network Adaptive Platform Trial (NCT05137119)
Clinically relevant stroke
Stroke is defined as the acute onset of focal neurological dysfunction caused by brain, spinal cord, or retinal vascular injury because of infarction (ischemia). Ideally, at least one of the following should be present to confirm the diagnosis of stroke: confirmation by neurology, stroke specialist, or neurosurgical specialist, brain imaging (e.g., CT scan, MRI scan, or cerebral vessel angiography compatible with acute ischemia). If the acute focal signs represent a worsening of a previous deficit, these signs must persist for more than 24 hours and be accompanied by an appropriate new MRI or CT scan finding. In the absence of neuroimaging, a staff neurologist consult which makes the diagnosis of stroke will be considered.
Time frame: Day 90 post enrollment in the S. aureus Network Adaptive Platform Trial (NCT05137119)
Clinically relevant acute myocardial infarction
Patients with S. aureus bacteremia often have substantial physiological stresses which can be associated with rises in cardiac troponin (demand ischemia). For the purposes of this outcome, acute myocardial infarction is captured as a type 1 myocardial infarction: detection of rise and/or fall of cardiac biomarkers with at least one value above the 99th percentile of the upper reference limit together with evidence of myocardial ischemia. For the purposes of this pragmatic trial, such a myocardial infarction will be inferred from the opinions of the staff cardiologist, intensivist, or general internal medicine specialist. The peak troponin value will be recorded, and a redacted copy of the relevant consultant's note and ECGs will be uploaded for audit.
Time frame: Day 90 post enrollment in the S. aureus Network Adaptive Platform Trial (NCT05137119)
Clinically relevant arterial thromboembolic event
Clinical history compatible with sudden worsening of end organ or limb perfusion and confirmation by imaging (e.g., CT angiography, arterial doppler) or need for urgent surgery or thrombolysis.
Time frame: Day 90 post enrollment in the S. aureus Network Adaptive Platform Trial (NCT05137119)
Plan to share: Yes — This statement supersedes any such statement in NCT05137119. For DABI-SNAP, we will provide deidentified individual patient data required to replicate the main manuscript's tables and analyses.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Analytic code
Time frame: Starting 1 year after the publication of the main trial manuscript for up to 7 years.
Access criteria: Researchers will need to request the data from the corresponding author of the main trial manuscript with an accompanying written proposal for the secondary analysis. Once approved by the trial steering committee, a data sharing agreement will be signed by the responsible parties and the deidentified data set will be provided via a secure transmission.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Dabigatran
McGill University Health Centre/Research Institute of the McGill University Health Centre →