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Grant: Project Grant

Research Institute of the McGill University Health Centre

$539,325.00

Dabigatran for the adjunctive treatment of Staphylococcus aureus bacteremia: the DABI-SNAP nested randomized controlled trial

EF 2023-24

Résumé
S. aureus bacteremia is the leading cause of death from bacterial infection, world-wide. There are an estimated 10,000 to 15,000 episodes per year in Canada resulting in 2,000-3000 deaths. New treatments to reduce morbidity and death are urgently needed. The S. aureus Network Adaptive Platform (SNAP) is an internationally funded series of clinical trials ongoing in several countries (Australia, Canada, Israel, New Zealand, Singapore, and the UK). Many patients with this condition are prescribed blood thinners. The blood thinner dabigatran may have activity against S.aureus. We will use this platform to test whether a patient who develops S. aureus bacteremia while taking a direct oral anticoagulants blood thinner has better outcomes if they are randomized to taking dabigratran versus continuing the non-dabigatran blood thinner they are already taking. By testing patients who already need to be taking a blood thinner, we minimize any risk of bleeding, while also being able to test the hypothesis that dabigatran is a superior therapy in patients with S. aureus bacteremia. This study uses a special type of outcome measurement called a Desirabilty Of Outcome Ranking, or a so-called "DOOR." This is a patient centered outcome as it factors in the desirability of the outcomes from a patient perspective. For example, death, treatment failure, and complications are ranked as outcomes. This type of outcome is interesting for patients and also helps to provide adequate power to smaller studies testing new hypotheses. The study is carried out by an international team of researchers (spanning career stages) and makes use of the existing SNAP study. Across more than 50 sites worldwide, we plan to recruit approximately 300 patients (150 to each therapy) and compare the combined outcome of death, treatment failure, and side effects like bleeding. If dabigatran appears to be beneficial, we will test the drug in people who aren't taking any blood thinners in a future study.
Programme
Project Grant
Emplacement
Quebec, Canada
Type
Grant
Source
CIHR Funding Decisions Database

Tel que publié

Id
500464
Name
McDonald Emily G
Region
Québec
Country
Canada
Orgtype
Institution Paid; Research Institution
Instname2
Infection and Immunity
Theme2
Clinical
Prcname2
Randomized Controlled Trials 2
Projecttitle
Dabigatran for the adjunctive treatment of Staphylococcus aureus bacteremia: the DABI-SNAP nested randomized controlled trial
Programtype2
Operating Grants
Orgnameinp2
Research Institute of the McGill University Health Centre
Cihramount2
$539,325
Cihrequipment2
$0
Programname2
Project Grant
Keyworddelim
Adjunctive Therapies; Anticoagulants; Comparative Effectiveness Trial; Desirability Of Ordinal Outcomes Rating; Infectious Diseases; Nested Trials; Platform Trial; Pragmatic Trials; Staph Aureus Bacteremia
Abstract
S. aureus bacteremia is the leading cause of death from bacterial infection, world-wide. There are an estimated 10,000 to 15,000 episodes per year in Canada resulting in 2,000-3000 deaths. New treatments to reduce morbidity and death are urgently needed. The S. aureus Network Adaptive Platform (SNAP) is an internationally funded series of clinical trials ongoing in several countries (Australia, Canada, Israel, New Zealand, Singapore, and the UK). Many patients with this condition are prescribed blood thinners. The blood thinner dabigatran may have activity against S.aureus. We will use this platform to test whether a patient who develops S. aureus bacteremia while taking a direct oral anticoagulants blood thinner has better outcomes if they are randomized to taking dabigratran versus continuing the non-dabigatran blood thinner they are already taking. By testing patients who already need to be taking a blood thinner, we minimize any risk of bleeding, while also being able to test the hypothesis that dabigatran is a superior therapy in patients with S. aureus bacteremia. This study uses a special type of outcome measurement called a Desirabilty Of Outcome Ranking, or a so-called "DOOR." This is a patient centered outcome as it factors in the desirability of the outcomes from a patient perspective. For example, death, treatment failure, and complications are ranked as outcomes. This type of outcome is interesting for patients and also helps to provide adequate power to smaller studies testing new hypotheses. The study is carried out by an international team of researchers (spanning career stages) and makes use of the existing SNAP study. Across more than 50 sites worldwide, we plan to recruit approximately 300 patients (150 to each therapy) and compare the combined outcome of death, treatment failure, and side effects like bleeding. If dabigatran appears to be beneficial, we will test the drug in people who aren't taking any blood thinners in a future study.
Competitiondate
202403
Approvedterm2
4 yrs 0 mth
Pinamesdelim
McDonald, Emily G; Cheng, Matthew P; Daneman, Nick; Davis, Joshua; Goodman, Anna L; Lawandi, Alexander; Lawler, Patrick R; Lee, Todd C; Mertz, Dominik; Paul, Mical; Siegal, Deborah M; Tong, Steven; Walls, Genevieve
Approvedterm
4 ans 0 mois
Cihrcontribution2
~ $539,325~ $0~