Direct Thrombin Inhibitors Versus LMWH in Staphylococcus Aureus Bacteraemia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Peter Verhamme, Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier:
NCT01911624
First received: June 14, 2013
Last updated: July 11, 2016
Last verified: July 2016
  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
Endpoint Classification: Safety/Efficacy Study
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.

Resource links provided by NLM:


Further study details as provided by 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • The primary efficacy outcome is the occurence of metastatic infection [ Time Frame: From randomization until month 3 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    D-dimeren, fibrinogen, APTT, PT dabigatran level or antiXa

  • Laboratory markers of inflammation [ Time Frame: From randomization until D7-10 ] [ Designated as safety issue: No ]
    CRP

  • Clinical outcomes after S. aureus bacteremia [ Time Frame: From randomization until M3 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 
Study First Received: June 14, 2013
Last Updated: July 11, 2016
Health Authority: Belgium: Federal Agency for Medicines and Health Products, FAMHP
Individual Participant Data  
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

ClinicalTrials.gov processed this record on July 21, 2016