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.

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01911624

Enrollment

Registered

2013-07-30

Start date

2013-01-31

Completion date

2016-07-31

Last updated

2016-07-13

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

Conditions

Staphylococcus Aureus Bacteraemia

Brief summary

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.

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.

Interventions

DRUGdirect thrombin inhibition

DRUGenoxaparin

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Primary Safety Outcome is the occurence of clinically-relevant bleeding events	From date of randomization up to end of study drug + 3 days

Secondary

Measure	Time frame	Description
The primary efficacy outcome is the occurence of metastatic infection	From randomization until month 3	as documented with a PET-CTscan in eligible patients on D7-10 or clinically-overt metastatic infectious foci

Other

Measure	Time frame	Description
Clinical outcomes after S. aureus bacteremia	From randomization until M3	—
Laboratory markers of coagulation	From randomization until D7-10	D-dimeren, fibrinogen, APTT, PT dabigatran level or antiXa
Laboratory markers of inflammation	From randomization until D7-10	CRP

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026