Dabigatran for the Adjunctive Treatment of Staphylococcus Aureus Bacteremia

Launched by EMILY MCDONALD · Oct 18, 2024

Keywords

ClinConnect Summary

This clinical trial is studying whether switching to a medication called dabigatran can help patients who have a serious bloodstream infection caused by Staphylococcus aureus (S. aureus bacteremia). Patients eligible for this study are those who are already taking certain blood thinners (like apixaban, edoxaban, or rivaroxaban) for conditions such as preventing strokes or treating blood clots. The goal is to see if changing to dabigatran, which has shown promise in laboratory tests against S. aureus, can improve health outcomes for these patients.

To participate, individuals must be between the ages of 65 and 74 and currently taking one of the specified blood thinners with at least 30 days of treatment left. However, those with active bleeding, certain upcoming surgeries, pregnancy, a recent allergy to dabigatran, or specific kidney issues will not qualify. Participants will be randomly assigned to either continue their current medication or switch to dabigatran. Throughout the trial, participants will receive regular follow-ups to monitor their health and treatment outcomes. This study is part of a larger research effort, and if successful, it could lead to further studies on dabigatran for people without current reasons for taking blood thinners.

Gender

ALL

Eligibility criteria

• The participant must meet all inclusion and exclusion criteria for the SNAP Platform (NCT05137119) and also the following inclusion and exclusion criteria:
• Inclusion Criteria:
• • Patient is taking an oral Xa inhibitor 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.
• Exclusion Criteria:
• • Active bleeding (allowing up to 5 days from the index blood culture to randomize in the event anti-thrombotic therapy is resumed)
• • Anticipated major cardiac surgery, neurosurgery, or spine surgery within the next 3 days
• • Pregnancy
• • 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 \[if acute kidney injury can allow for up to 5 days from index blood culture to allow for recovery\]
• • Off label use (e.g., metallic mechanical heart valve, left ventricular thrombus, antiphospholipid antibody syndrome)