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Dabigatran for Staph Bloodstream Infection (DABI-SNAP Trial)

Phase 4
Waitlist Available
Led By Emily G McDonald, MD MSC
Research Sponsored by Emily McDonald
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Must not have
Known use of dabigatran within last month
Off label use (e.g., metallic mechanical heart valve, left ventricular thrombus, antiphospholipid antibody syndrome)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 90 post enrollment in the s. aureus network adaptive platform trial (nct05137119)
Awards & highlights
Pivotal Trial
No Placebo-Only Group
Drug Has Already Been Approved

Summary

This trial will enroll patients with S. aureus bacteremia who are already taking certain oral anticoagulant medications. The study will compare staying on their current medication or switching to a different medication called

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Potential side effects of the anticoagulants including dabigatran can include bleeding complications, digestive discomfort, and allergic reactions. Dabigatran specifically might also have effects against S. aureus.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have taken dabigatran in the last month.
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I am using medication for conditions not listed on the label.
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I am currently taking medications like amiodarone or ketoconazole.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 90 post enrollment in the s. aureus network adaptive platform trial (nct05137119)
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 90 post enrollment in the s. aureus network adaptive platform trial (nct05137119) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Desirability of Outcome Ranking (DOOR)
Secondary study objectives
All cause mortality
Clinical failure
Clinically relevant acute myocardial infarction
+6 more

Side effects data

From undefined Phase 3 trial • 2867 Patients • NCT00329238
8%
Nasopharyngitis
8%
Pain in extremity
6%
Headache
5%
Oedema peripheral
5%
Influenza
5%
Diarrhoea
3%
Epistaxis
1%
Deep vein thrombosis
1%
Pulmonary embolism
100%
80%
60%
40%
20%
0%
Study treatment Arm
Dabigatran
Warfarin
Post Warfarin
Post Dabigatran

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Change to DabigatranExperimental Treatment1 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 anticoagulantActive Control3 Interventions
Patients will continue their currently prescribed apixaban, edoxaban, or rivaroxaban
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dabigatran
2011
Completed Phase 4
~286770

Find a Location

Who is running the clinical trial?

University of MelbourneOTHER
181 Previous Clinical Trials
1,281,943 Total Patients Enrolled
1 Trials studying Staphylococcus Aureus Endocarditis
300 Patients Enrolled for Staphylococcus Aureus Endocarditis
Emily McDonaldLead Sponsor
1 Previous Clinical Trials
56 Total Patients Enrolled
Emily G McDonald, MD MSCPrincipal InvestigatorResearch Institute of the McGill University Health Centre
~200 spots leftby Jan 2029
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