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Direct Thrombin Inhibitors Versus LMWH in Staphylococcus Aureus Bacteraemia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01911624
First Posted: July 30, 2013
Last Update Posted: July 13, 2016
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.
Information provided by (Responsible Party):
Peter Verhamme, Universitaire Ziekenhuizen Leuven
  Purpose

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 Intervention Phase
Staphylococcus Aureus Bacteraemia Drug: direct thrombin inhibition Drug: enoxaparin Phase 2

Study Type: Interventional
Study Design: 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.

Resource links provided by NLM:


Further study details as provided by Peter Verhamme, Universitaire Ziekenhuizen Leuven:

Primary Outcome Measures:
  • 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:
  • 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:
  • 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 ]

Enrollment: 94
Study Start Date: January 2013
Study Completion Date: July 2016
Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Information from the National Library of Medicine

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

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.
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01911624


Locations
Belgium
KUleuven/UZ Gasthuisberg
Leuven, Belgium, 3000
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
Investigators
Principal Investigator: Peter Verhamme, Doctor Bloedings-en vaatziekten, UZ Gasthuisberg
  More Information

Responsible Party: Peter Verhamme, Prof., Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT01911624     History of Changes
Other Study ID Numbers: S54881
First Submitted: June 14, 2013
First Posted: July 30, 2013
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:
Bacteremia
Bacterial Infections
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Dabigatran
Argatroban
Antithrombins
Thrombin
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants
Hemostatics
Coagulants
Platelet Aggregation Inhibitors