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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
June 14, 2013
July 30, 2013
July 13, 2016
January 2013
April 2016   (Final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01911624 on ClinicalTrials.gov Archive Site
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
Same as current
  • 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 ]
  • Laboratory markers of coagulation [ Time Frame: From randomization until D7-10 ]
  • Laboratory markers of inflammation [ Time Frame: From randomization until D7-10 ]
  • Clinical outcomes after S. aureus bacteremia [ Time Frame: From randomization until M3 ]
 
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.

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.

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.
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Staphylococcus Aureus Bacteraemia
  • Drug: direct thrombin inhibition
    Other Names:
    • dabigatran
    • argatroban
  • Drug: enoxaparin
    Other Name: clexane
  • Experimental: direct thrombin inhibition
    dabigatran 110 mg BID, po argatroban (0.5 - 1 µg/kg/min) if peroral therapy is not possible
    Intervention: Drug: direct thrombin inhibition
  • Active Comparator: enoxaparin
    enoxaparin 40 mg od, sc
    Intervention: Drug: enoxaparin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
94
July 2016
April 2016   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 90 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Belgium
 
 
NCT01911624
S54881
No
Not Provided
Plan to Share IPD: Undecided
Peter Verhamme, Universitaire Ziekenhuizen Leuven
Universitaire Ziekenhuizen Leuven
Not Provided
Principal Investigator: Peter Verhamme, Doctor Bloedings-en vaatziekten, UZ Gasthuisberg
Universitaire Ziekenhuizen Leuven
July 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP