Direct Thrombin Inhibitors Versus LMWH in Staphylococcus Aureus Bacteraemia
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.
|Staphylococcus Aureus Bacteraemia||Drug: direct thrombin inhibition Drug: enoxaparin||Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
|Official Title:||Direct Thrombin Inhibitors Versus LMWH in Staphylococcus Aureus Bacteraemia. A Prospective Randomized Controlled Academic Single-centre Feasibility Study.|
- Primary Safety Outcome is the occurence of clinically-relevant bleeding events [ Time Frame: From date of randomization up to end of study drug + 3 days ]
- The primary efficacy outcome is the occurence of metastatic infection [ Time Frame: From randomization until month 3 ]as documented with a PET-CTscan in eligible patients on D7-10 or clinically-overt metastatic infectious foci
- Laboratory markers of coagulation [ Time Frame: From randomization until D7-10 ]D-dimeren, fibrinogen, APTT, PT dabigatran level or antiXa
- Laboratory markers of inflammation [ Time Frame: From randomization until D7-10 ]CRP
- Clinical outcomes after S. aureus bacteremia [ Time Frame: From randomization until M3 ]
|Study Start Date:||January 2013|
|Study Completion Date:||July 2016|
|Primary Completion Date:||April 2016 (Final data collection date for primary outcome measure)|
Experimental: direct thrombin inhibition
dabigatran 110 mg BID, po argatroban (0.5 - 1 µg/kg/min) if peroral therapy is not possible
Drug: direct thrombin inhibition
Active Comparator: enoxaparin
enoxaparin 40 mg od, sc
Other Name: clexane
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01911624
|Leuven, Belgium, 3000|
|Principal Investigator:||Peter Verhamme, Doctor||Bloedings-en vaatziekten, UZ Gasthuisberg|