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

NCT06650501 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2026-03-20

No results posted yet for this study

Summary

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.

Conditions

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

Interventions

DRUG

Dabigatran

Patients will be assigned to change to dabigatran at the monograph approved dose for their indication, bleeding risk, and renal function.

DRUG

Apixaban

Patients will continue taking their currently prescribed apixaban, edoxaban, or rivaroxaban

DRUG

edoxaban

Patients will continue taking their currently prescribed apixaban, edoxaban, or rivaroxaban

DRUG

Rivaroxaban

Patients will continue taking their currently prescribed apixaban, edoxaban, or rivaroxaban

Sponsors & Collaborators

  • University of Melbourne

    collaborator OTHER

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

    lead OTHER

Principal Investigators

  • Emily G McDonald, MD MSC · Research Institute of the McGill University Health Centre

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-15
Primary Completion
2030-01-31
Completion
2030-01-31

Countries

  • Canada

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06650501 on ClinicalTrials.gov