Direct Thrombin Inhibitors Versus LMWH in Staphylococcus Aureus Bacteraemia

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.

Inclusion Criteria:

• Positive blood culture for staphylococcus aureus
• Symptoms or signs of infection
• Indication for thromboprophylaxis

Exclusion Criteria:

• Contraindication for thromboprophylaxis
• Significant active bleeding or risk of excessive bleeding
• Heparin-induced thrombocytopenia
• Severe liver and kidney disease
• Pregnancy and lactation.