Dabigatran for Staph Bloodstream Infection

(DABI-SNAP Trial)

Overseen By Lina Petrella

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Emily McDonald

Must be taking: Oral Xa inhibitors

Must not be taking: Dabigatran, Amiodarone, Ketoconazole, others

Disqualifiers: Active bleeding, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how well dabigatran, a blood thinner, works against Staph bloodstream infections in individuals already taking blood thinners for other health issues, such as stroke prevention or blood clot treatment. Researchers aim to determine if switching to dabigatran offers better results than continuing with current medications. Suitable candidates for this trial include those currently on blood thinners like apixaban, edoxaban, or rivaroxaban for conditions such as atrial fibrillation or post-surgery, who also have a Staph bloodstream infection. As a Phase 4 trial, this research seeks to understand how dabigatran, an FDA-approved and effective treatment, can benefit more patients.

Will I have to stop taking my current medications?

The trial may require you to switch from your current oral anticoagulant medication to dabigatran, but you won't have to stop taking anticoagulants altogether. The decision to switch will depend on the randomization process in the study.

What is the safety track record for dabigatran?

Research shows that dabigatran, a medication used to prevent blood clots and strokes, might also be safe for treating Staphylococcus aureus infections. Studies have found that dabigatran is associated with fewer Staphylococcus aureus bloodstream infections compared to some other blood thinners, suggesting it could help manage these infections safely.

Dabigatran is already commonly used for other health issues, providing some confidence about its safety. It has been tested in many patients, and although all medications can have side effects, dabigatran is generally well-tolerated. For those considering joining the trial, this background indicates that the safety of dabigatran is well understood. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Unlike the standard anticoagulants for Staph bloodstream infections, such as apixaban, edoxaban, or rivaroxaban, dabigatran offers a unique approach by directly inhibiting thrombin, a key enzyme in the blood clotting process. Researchers are excited about dabigatran because this specific mechanism might reduce the risk of complications associated with Staph infections more effectively. Additionally, dabigatran has a predictable pharmacokinetic profile, which means it might require less monitoring compared to some other anticoagulants, potentially simplifying treatment for both patients and healthcare providers.

What evidence suggests that dabigatran might be an effective treatment for Staph bloodstream infection?

Research has shown that dabigatran might help combat Staphylococcus aureus, a bacteria responsible for serious blood infections. In this trial, some participants will switch their anticoagulation to dabigatran. Studies have found that individuals taking dabigatran experienced fewer infections compared to those using other blood thinners like rivaroxaban. Dabigatran appears to work by preventing the bacteria from forming clots, which serve as protective barriers aiding their survival. This clot-busting effect was observed in both lab tests and animal studies, suggesting that dabigatran could help prevent or reduce these infections in people. ^{1 2 6 7 8}

Who Is on the Research Team?

Emily G McDonald, MD MSC

Principal Investigator

Research Institute of the McGill University Health Centre

Are You a Good Fit for This Trial?

This trial is for patients with a Staphylococcus aureus blood infection who are already on oral anticoagulants like apixaban, edoxaban, or rivaroxaban. Participants must be taking these medications for conditions such as stroke prevention in atrial fibrillation or to prevent/treat blood clots.

Inclusion Criteria

I am currently on an oral Xa inhibitor for stroke prevention or treating blood clots.

Exclusion Criteria

Allergy to dabigatran

I have taken dabigatran in the last month.

I haven't had active bleeding in the last 5 days.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to continue their current anticoagulant or switch to dabigatran for the treatment of S. aureus bacteremia

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

Open-label extension (optional)

Participants may opt into continuation of treatment long-term

Long-term

What Are the Treatments Tested in This Trial?

Interventions

• Dabigatran

Trial Overview The study tests if switching from current anticoagulant medication to dabigatran (which may fight S. aureus) improves patient outcomes. It's an open-label randomized trial where some continue their meds while others switch to dabigatran.

How Is the Trial Designed?

Group I: Change to Dabigatran Experimental Treatment 1 Intervention

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

Group II: Continue current anticoagulant Active Control 3 Interventions

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

Who Is Running the Clinical Trial?

Emily McDonald

Lead Sponsor

Trials

2

Recruited

360+

University of Melbourne

Collaborator

Trials

193

Recruited

1,287,000+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/32478836/

Dabigatran and the Risk of Staphylococcus aureus ... Treatment with dabigatran was associated with a significantly lower incidence rate of SAB compared with treatment with factor Xa-inhibitors.

2. infectiousdiseaseadvisor.com infectiousdiseaseadvisor.com/news/incidence-of-s-aureus-bacteremia-with-dabigatran-vs-factor-xa-inhibitors-for-atrial-fibrillation/

Assessment of Bacteremia Associated With Anticoagulant ... Dabigatran was associated with a decreased incidence of Staphylococcus aureus bacteremia compared with factor Xa inhibitors rivaroxaban and ...

3. vbn.aau.dk vbn.aau.dk/files/460115674/2020_Dabigatran_and_The_Risk_of_Staphylococcus_..._1_.pdf

Dabigatran and The Risk of Staphylococcus Aureus ... The primary outcome was SAB. The Danish Staphylococcal Bacteremia Database contains clinical data on more than 95% of all positive S. aureus isolates identified ...

4. journals.plos.org journals.plos.org/plospathogens/article/file?id=10.1371/journal.ppat.1002307&type=printable

Preventing Staphylococcus aureus Sepsis through the S. aureus agglutination could be disrupted and the lethal outcome of sepsis could be prevented by combining dabigatran-etexilate treatment, ...

5. journals.asm.org journals.asm.org/doi/10.1128/jcm.00896-10

Dabigatran Inhibits Staphylococcus aureus Coagulase Activity Our results demonstrate that the direct thrombin inhibitor dabigatran effectively inhibits the staphylothrombin-induced clotting of human plasma ...

6. researchgate.net researchgate.net/publication/375953691_978_Association_of_oral_anticoagulation_therapy_with_dabigatran_and_the_incidence_rate_of_Staphylococcus_aureus_bacteremia_among_patients_with_atrial_fibrillation

(PDF) 978. Association of oral anticoagulation therapy with ... Association of oral anticoagulation therapy with dabigatran and the incidence rate of Staphylococcus aureus bacteremia among patients with ...

7. researchprofiles.ku.dk researchprofiles.ku.dk/en/publications/dabigatran-and-the-risk-of-istaphylococcus-aureusi-bacteremia-a-n/

Dabigatran and the Risk of >Staphylococcus aureus ... BACKGROUND: Treatment with dabigatran, an oral direct thrombin inhibitor, reduces the virulence of Staphylococcus aureus in in vitro and in vivo models.

8. semanticscholar.org semanticscholar.org/paper/Dabigatran-and-The-Risk-of-Staphylococcus-Aureus-A-Butt-Fosb%C3%B8l/526f637f5a275e101617d31804edda59e0ada59c

[PDF] Dabigatran and The Risk of Staphylococcus Aureus ... Treatment with dabigatran was associated with a significantly lower incidence rate of SAB compared with treatment with factor Xa-inhibitors.