NCT01911624

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.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 94 (actual)
• Sponsor: Universitaire Ziekenhuizen KU Leuven · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Staphylococcus Aureus Bacteraemia

Interventions

Type	Name	Description
DRUG	direct thrombin inhibition
DRUG	enoxaparin

Timeline

• Start date: 2013-01-01
• Primary completion: 2016-04-01
• Completion: 2016-07-01
• First posted: 2013-07-30
• Last updated: 2016-07-13

Locations

1 site across 1 country: Belgium