Direct Thrombin Inhibitors Versus LMWH in Staphylococcus Aureus Bacteraemia

Phase 2

Completed

• Conditions: Staphylococcus Aureus Bacteraemia
• Interventions: Drug: direct thrombin inhibition; Drug: enoxaparin

• Registration Number: NCT01911624
• Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

Brief 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.

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2013-06-14
• Study First Submitted QC: 2013-07-25
• Study First Posted: 2013-07-30
• Primary Completion: 2016-04
• Status Verified: 2016-07
• Study Completion: 2016-07
• Last Update Submitted: 2016-07-11
• Last Update Posted: 2016-07-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 94

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
direct thrombin inhibition	direct thrombin inhibition	dabigatran 110 mg BID, po argatroban (0.5 - 1 µg/kg/min) if peroral therapy is not possible
enoxaparin	enoxaparin	enoxaparin 40 mg od, sc

Primary Outcome Measures

Name	Time	Method
Primary Safety Outcome is the occurence of clinically-relevant bleeding events	From date of randomization up to end of study drug + 3 days

Secondary Outcome Measures

Name	Time	Method
The primary efficacy outcome is the occurence of metastatic infection	From randomization until month 3	as documented with a PET-CTscan in eligible patients on D7-10 or clinically-overt metastatic infectious foci

Trial Locations

Locations (1)

KUleuven/UZ Gasthuisberg; 🇧🇪 Leuven, Belgium