Staphylococcus Aureus Bacteraemia Clinical Trial
Official title:
Direct Thrombin Inhibitors Versus LMWH in Staphylococcus Aureus Bacteraemia. A Prospective Randomized Controlled Academic Single-centre Feasibility Study.
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.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label