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NCT Number: NCT01911624

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.

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Key information

Conditions

Staphylococcus Aureus Bacteraemia

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

KUleuven/UZ Gasthuisberg

Leuven, 3000, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

direct thrombin inhibition

Drug

Other names: dabigatran, argatroban

Enoxaparin

Drug

Other names: clexane

Primary outcomes

  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 outcomes

  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 outcomes

  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

    CRP

  3. Clinical outcomes after S. aureus bacteremia

    Time frame: From randomization until M3

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Registry information

Official study title

Direct Thrombin Inhibitors Versus LMWH in Staphylococcus Aureus Bacteraemia. A Prospective Randomized Controlled Academic Single-centre Feasibility Study.

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Jul 30, 2013
Registry last updated
Jul 13, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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