Safety and efficacy of direct thrombin inhibitors versus enoxaparin in patients with staphylococcus aureus bacteraemia. The study hypothesizes that inhibition of the coagulase-activity of S. aureus by direct thrombin inhibitors is safe and translates into a better outcome of patients with S. aureus bacteremia.
Single center randomized controlled trial of direct thrombin inhibitors versus standard enoxaparin. * Feasibility: proportion of patients eligible for randomization; clinically attained concentration of DTI and resulting staphylothrombin inhibition * Safety: bleeding events (major/ clinically relevant non-major) * Efficacy: thrombotic events during the thromboprophylactic treatment + 3 days * Secondary outcome measures * Coagulation parameters: evolution of D-dimers from day 0-4; other lab parameters of coagulation (PT/APTT/fibrinogen/platelet count) * Inflammatory parameters: CRP, white blood cell count, neutrophilia * Clinical outcomes: metastatic infections, assessed clinically or by PET/CT; relapse of S. aureus bacteremia; defervescence; persistent positive blood cultures; hospital stay, mortality.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
NONE
Enrollment
94
KUleuven/UZ Gasthuisberg
Leuven, Belgium
Primary Safety Outcome is the occurence of clinically-relevant bleeding events
Time frame: From date of randomization up to end of study drug + 3 days
The primary efficacy outcome is the occurence of metastatic infection
as documented with a PET-CTscan in eligible patients on D7-10 or clinically-overt metastatic infectious foci
Time frame: From randomization until month 3
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