Direct Thrombin Inhibitors Versus LMWH in Staphylococcus Aureus Bacteraemia

Universitaire Ziekenhuizen KU Leuven

Status and phase: Completed; Phase 2

Conditions: Staphylococcus Aureus Bacteraemia

Treatments: Drug: enoxaparin; Drug: direct thrombin inhibition

Study type: Interventional

Funder types: Other

Identifiers

NCT01911624

S54881

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 94 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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.

Trial design

94 participants in 2 patient groups

direct thrombin inhibition

Experimental group

Description:

dabigatran 110 mg BID, po argatroban (0.5 - 1 µg/kg/min) if peroral therapy is not possible

Treatment:

Drug: direct thrombin inhibition

enoxaparin

Active Comparator group

Description:

enoxaparin 40 mg od, sc

Treatment:

Drug: enoxaparin