NCT06650501

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for phase_4

Timeline
44mo left

Started Jan 2026

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress8%
Jan 2026Jan 2030

First Submitted

Initial submission to the registry

October 18, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 21, 2024

Completed
1.2 years until next milestone

Study Start

First participant enrolled

January 15, 2026

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2030

Last Updated

March 20, 2026

Status Verified

January 1, 2026

Enrollment Period

4 years

First QC Date

October 18, 2024

Last Update Submit

March 17, 2026

Conditions

Staphylococcus Aureus EndocarditisStaphylococcus Aureus SepticemiaStaphylococcus Aureus BacteremiaStaphylococcus Aureus Bloodstream InfectionS. Aureus BacteremiaS. Aureus Bloodstream Infection

Keywords

S. aureus bacteremiaS. aureus bloodstream infectionS. aureus endocarditisDabigatranEdoxabanRivaroxabanApixaban

Outcome Measures

Primary Outcomes (1)

  • 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

    Day 90 post enrollment in the S. aureus Network Adaptive Platform Trial (NCT05137119)

Secondary Outcomes (9)

  • Clinical failure

    Day 90 post enrollment in the S. aureus Network Adaptive Platform Trial (NCT05137119)

  • Serious Adverse Event or Adverse Event Leading to Discontinuation

    Day 90 post enrollment in the S. aureus Network Adaptive Platform Trial (NCT05137119)

  • All cause mortality

    Day 90 post enrollment in the S. aureus Network Adaptive Platform Trial (NCT05137119)

  • Infectious Complications

    Day 90 post enrollment in the S. aureus Network Adaptive Platform Trial (NCT05137119)

  • Clinically relevant major bleeding

    Day 90 post enrollment in the S. aureus Network Adaptive Platform Trial (NCT05137119)

  • +4 more secondary outcomes

Study Arms (2)

Change to Dabigatran

EXPERIMENTAL

Patients will have their anticoagulation changed to dabigatran at the monograph approved dose for the indication, bleeding risk, and renal function.

Drug: Dabigatran

Continue current anticoagulant

ACTIVE COMPARATOR

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

Drug: ApixabanDrug: edoxabanDrug: Rivaroxaban

Interventions

ApixabanDRUG

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

Continue current anticoagulant
edoxabanDRUG

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

Continue current anticoagulant
RivaroxabanDRUG

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

Continue current anticoagulant
DabigatranDRUG

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

Change to Dabigatran

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • Patient is taking (or will imminently start taking) an oral Xa inhibitor (e.g., apixaban, edoxaban, rivaroxaban) for: stroke prevention in atrial fibrillation, treatment or secondary prevention of deep venous thrombosis or pulmonary embolism, prevention of VTE in patients who have undergone elective total hip or total knee replacement surgery provided there are 30 or more days of planned treatment remaining at the time of enrolment.
  • Active bleeding as determine by the site investigator after discussion with the treating team (patient may remain eligible for up to 120 hours from platform entry if condition is resolved and antithrombotic therapy is resumed)
  • Anticipated major cardiac surgery, neurosurgery, or spine surgery within the next 3 days
  • Known pregnancy (with testing available for women with childbearing potential)
  • Known use of dabigatran within last month
  • Allergy to dabigatran
  • Concomitant use of amiodarone, ketoconazole, rifampin, verapamil, clopidogrel, prasugrel, or ticagrelor
  • eGFR \< 30mL/minute calculated by Cockcroft-Gault equation using adjusted weight \[patient may remain eligible for up to 120 hours from platform entry if acute kidney injury is resolved such that antithrombotic therapy can be safely resumed/prescribed\]
  • Off label use (e.g., metallic mechanical heart valve, left ventricular thrombus, antiphospholipid antibody syndrome)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

McGill University Health Centre (Royal Victoria Hospital and Montreal General Hospital)

Montreal, Quebec, H4A3S1, Canada

RECRUITING

Related Publications (7)

  • Lerche CJ, Christophersen LJ, Goetze JP, Nielsen PR, Thomsen K, Enevold C, Hoiby N, Jensen PO, Bundgaard H, Moser C. Adjunctive dabigatran therapy improves outcome of experimental left-sided Staphylococcus aureus endocarditis. PLoS One. 2019 Apr 19;14(4):e0215333. doi: 10.1371/journal.pone.0215333. eCollection 2019.

    PMID: 31002679BACKGROUND

  • Butt JH, Fosbol EL, Verhamme P, Gerds TA, Iversen K, Bundgaard H, Bruun NE, Larsen AR, Petersen A, Andersen PS, Skov RL, Gislason GH, Torp-Pedersen C, Kober L, Olesen JB. Dabigatran and the Risk of Staphylococcus aureus Bacteremia: A Nationwide Cohort Study. Clin Infect Dis. 2021 Aug 2;73(3):480-486. doi: 10.1093/cid/ciaa661.

    PMID: 32478836BACKGROUND

  • Vanassche T, Verhaegen J, Peetermans WE, VAN Ryn J, Cheng A, Schneewind O, Hoylaerts MF, Verhamme P. Inhibition of staphylothrombin by dabigatran reduces Staphylococcus aureus virulence. J Thromb Haemost. 2011 Dec;9(12):2436-46. doi: 10.1111/j.1538-7836.2011.04529.x.

    PMID: 22040101BACKGROUND

  • Vanassche T, Verhaegen J, Peetermans WE, Hoylaerts MF, Verhamme P. Dabigatran inhibits Staphylococcus aureus coagulase activity. J Clin Microbiol. 2010 Nov;48(11):4248-50. doi: 10.1128/JCM.00896-10. Epub 2010 Sep 1.

    PMID: 20810780BACKGROUND

  • Peetermans M, Liesenborghs L, Peerlinck K, Wijngaerden EV, Gheysens O, Goffin KE, Hoylaerts MF, Jacquemin M, Verhaegen J, Peetermans WE, Verhamme P, Vanassche T; Staphylothrombin Investigators. Targeting Coagulase Activity in Staphylococcus aureus Bacteraemia: A Randomized Controlled Single-Centre Trial of Staphylothrombin Inhibition. Thromb Haemost. 2018 May;118(5):818-829. doi: 10.1055/s-0038-1639586. Epub 2018 Apr 3.

    PMID: 29614521BACKGROUND

  • Tong SYC, Mora J, Bowen AC, Cheng MP, Daneman N, Goodman AL, Heriot GS, Lee TC, Lewis RJ, Lye DC, Mahar RK, Marsh J, McGlothlin A, McQuilten Z, Morpeth SC, Paterson DL, Price DJ, Roberts JA, Robinson JO, van Hal SJ, Walls G, Webb SA, Whiteway L, Yahav D, Davis JS; Staphylococcus aureus Network Adaptive Platform (SNAP) Study Group. The Staphylococcus aureus Network Adaptive Platform Trial Protocol: New Tools for an Old Foe. Clin Infect Dis. 2022 Nov 30;75(11):2027-2034. doi: 10.1093/cid/ciac476.

    PMID: 35717634BACKGROUND

  • McDonald EG, Cheng MP, Davis JS, Goodman AL, Lawler PR, Marsh J, Mertz D, Paul M, Rodriguez-Bano J, Siegal DM, Tong SY, Walls G, Lee TC; SNAP Global Trial Steering Committee. Is there a role for anticoagulation with dabigatran in S. aureus bacteremia? Protocol for the adjunctive treatment domain of the Staphylococcus aureus Network Adaptive Platform (SNAP) randomised controlled trial. BMJ Open. 2025 Dec 12;15(12):e107493. doi: 10.1136/bmjopen-2025-107493.

    PMID: 41387009DERIVED

Related Links

MeSH Terms

Interventions

DabigatranapixabanedoxabanRivaroxaban

Intervention Hierarchy (Ancestors)

PyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingThiophenesSulfur CompoundsOrganic ChemicalsMorpholinesOxazines

Study Officials

  • Emily G McDonald, MD MSC

    Research Institute of the McGill University Health Centre

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lina Petrella

CONTACT

514-934-1934lina.petrella@muhc.mcgill.ca

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Medicine and Staff Scientist

Study Record Dates

First Submitted

October 18, 2024

First Posted

October 21, 2024

Study Start

January 15, 2026

Primary Completion (Estimated)

January 1, 2030

Study Completion (Estimated)

January 1, 2030

Last Updated

March 20, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, ICF, 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.

Locations

CA(1)