Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06650501
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-18
Brief Title:
Dabigatran for the Adjunctive Treatment of Staphylococcus Aureus Bacteremia
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Dabigatran for the Adjunctive Treatment of Staphylococcus Aureus Bacteremia the DABI-SNAP Nested Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DABI-SNAP
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 dabigratran 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
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 dabigratran 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None