Direct Thrombin Inhibitors Versus LMWH in Staphylococcus Aureus Bacteraemia
NCT ID: NCT01911624
Last Updated: 2016-07-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
94 participants
INTERVENTIONAL
2013-01-31
2016-07-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Coagulation and Fibrinolysis as Virulence Factors for Invasive Staphylococcus Aureus and Streptococcus Infections
NCT01731483
A Phase 3 Telavancin Staphylococcus Aureus (S. Aureus) Bacteremia Trial
NCT02208063
Dabigatran for the Adjunctive Treatment of Staphylococcus Aureus Bacteremia
NCT06650501
Telavancin for Treatment of Uncomplicated Staphylococcus Aureus Bacteremia
NCT00062647
Treatment Algorithm to Reduce the Use of Vancomycin in Adults With Blood Stream Infection
NCT01191840
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
* 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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
direct thrombin inhibition
dabigatran 110 mg BID, po argatroban (0.5 - 1 µg/kg/min) if peroral therapy is not possible
direct thrombin inhibition
enoxaparin
enoxaparin 40 mg od, sc
enoxaparin
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
direct thrombin inhibition
enoxaparin
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Symptoms or signs of infection
* Indication for thromboprophylaxis
Exclusion Criteria
* Significant active bleeding or risk of excessive bleeding
* Heparin-induced thrombocytopenia
* Severe liver and kidney disease
* Pregnancy and lactation.
18 Years
90 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Universitaire Ziekenhuizen KU Leuven
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Peter Verhamme
Prof.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Peter Verhamme, Doctor
Role: PRINCIPAL_INVESTIGATOR
Bloedings-en vaatziekten, UZ Gasthuisberg
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
KUleuven/UZ Gasthuisberg
Leuven, , Belgium
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
S54881
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.