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Direct Thrombin Inhibitors Versus LMWH in Staphylococcus Aureus Bacteraemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01911624
Recruitment Status : Completed
First Posted : July 30, 2013
Last Update Posted : July 13, 2016
Information provided by (Responsible Party):
Peter Verhamme, Universitaire Ziekenhuizen 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.

Condition or disease Intervention/treatment Phase
Staphylococcus Aureus Bacteraemia Drug: direct thrombin inhibition Drug: enoxaparin Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 94 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Direct Thrombin Inhibitors Versus LMWH in Staphylococcus Aureus Bacteraemia. A Prospective Randomized Controlled Academic Single-centre Feasibility Study.
Study Start Date : January 2013
Actual Primary Completion Date : April 2016
Actual Study Completion Date : July 2016

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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
Other Names:
  • dabigatran
  • argatroban

Active Comparator: enoxaparin
enoxaparin 40 mg od, sc
Drug: enoxaparin
Other Name: clexane

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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

Other Outcome Measures:
  1. Laboratory markers of coagulation [ Time Frame: From randomization until D7-10 ]
    D-dimeren, fibrinogen, APTT, PT dabigatran level or antiXa

  2. Laboratory markers of inflammation [ Time Frame: From randomization until D7-10 ]

  3. Clinical outcomes after S. aureus bacteremia [ Time Frame: From randomization until M3 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01911624

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KUleuven/UZ Gasthuisberg
Leuven, Belgium, 3000
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
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Principal Investigator: Peter Verhamme, Doctor Bloedings-en vaatziekten, UZ Gasthuisberg
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Responsible Party: Peter Verhamme, Prof., Universitaire Ziekenhuizen Leuven Identifier: NCT01911624    
Other Study ID Numbers: S54881
First Posted: July 30, 2013    Key Record Dates
Last Update Posted: July 13, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Bacterial Infections
Systemic Inflammatory Response Syndrome
Pathologic Processes
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Platelet Aggregation Inhibitors