Comparison of direct thrombin inhibitors versus low molecular weight heparins for the prevention of venous thromboembolism in patients with Staphylococcus aureus bacteraemia.

Direct thrombin inhibitors versus low molecular weight heparins as thromboprophylaxis in Staphylococcus aureus bacteraemia. A prospective randomized controlled academic single-centre feasibility study

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-004863-29-BE

Enrollment

Unknown

Registered

2013-01-29

Start date

2013-02-18

Completion date

Unknown

Last updated

2016-10-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

staphylococcus aureus bacteraemia

Interventions

Trade Name: Pradaxa Pharmaceutical Form: Capsule INN or Proposed INN: DABIGATRAN ETEXILATE CAS Number: 211915-06-9 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 1

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Positive blood culture for staphylococcus aureus in an adult patient with symptoms or signs of infection. Indication for thromboprophylaxis Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 40 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 40

Exclusion criteria

Exclusion criteria: Contraindication for thromboprophylaxis. Clinically significant active bleeding or risk of excessive bleeding. Heparin-induced thrombocytopenia. Severe liver and kidney disease. Pregnancy and lactation.

Design outcomes

Primary

Measure	Time frame
Main Objective: Efficacy and safety of direct thrombin inhibitors (dabigatran or argatroban) versus LMWH (clexane) in patients with staphylococcus aureus bacteraemia. Effect on coagulation parameters. ;Secondary Objective: Characterization of Staphylococcus aureus strains from clinical cases. Detection of metastatic foci using PET/CT in a subgroup of high risk patients. Correlation of the risk of metastatic infection with clinical and microbiological parameters.;Primary end point(s): Safety of dabigatran/argatroban versus enoxaparin (bleeding, adverse effects) Efficacy of dabigatran/argatroban versus enoxaparin (venous thrombo-embolism) Difference in coagulation parameters between dabigatran/argatroban and enoxaparin treated patients.;Timepoint(s) of evaluation of this end point: Interim analysis after 20 patients	—

Measure

Time frame

Main Objective: Efficacy and safety of direct thrombin inhibitors (dabigatran or argatroban) versus LMWH (clexane) in patients with staphylococcus aureus bacteraemia. Effect on coagulation parameters. ;Secondary Objective: Characterization of Staphylococcus aureus strains from clinical cases. Detection of metastatic foci using PET/CT in a subgroup of high risk patients. Correlation of the risk of metastatic infection with clinical and microbiological parameters.;Primary end point(s): Safety of dabigatran/argatroban versus enoxaparin (bleeding, adverse effects) Efficacy of dabigatran/argatroban versus enoxaparin (venous thrombo-embolism) Difference in coagulation parameters between dabigatran/argatroban and enoxaparin treated patients.;Timepoint(s) of evaluation of this end point: Interim analysis after 20 patients

—

Secondary

Measure	Time frame
Secondary end point(s): Clinical course of staphylococcus aureus infection (hospital stay, relapse, mortality) Metastatic infection score ;Timepoint(s) of evaluation of this end point: Interim analysis after 20 patients	—

Countries

Belgium

Contacts

Public ContactBarbara Debaveye

University Hospitals Leuven (Gasthuisberg)

03216341463

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026