Staphylococcus Aureus BacteraemiaPhase 2NCT01911624
Direct Thrombin Inhibitors Versus LMWH in Staphylococcus Aureus Bacteraemia
A Phase 2 study testing direct thrombin inhibition and enoxaparin in people with Staphylococcus Aureus Bacteraemia, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Staphylococcus Aureus Bacteraemia
- What is being tested?
- direct thrombin inhibition and enoxaparin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 1 siteBelgium
- Study dates
- Jan 2013to Jul 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Positive blood culture for staphylococcus aureus
- Symptoms or signs of infection
- Indication for thromboprophylaxis
Who cannot join
- Contraindication for thromboprophylaxis
- Significant active bleeding or risk of excessive bleeding
- Heparin-induced thrombocytopenia
- Severe liver and kidney disease
- Pregnancy and lactation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Direct Thrombin Inhibitors Versus LMWH in Staphylococcus Aureus Bacteraemia. A Prospective Randomized Controlled Academic Single-centre Feasibility Study.
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.
Read the 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.
- Conditions
- Staphylococcus Aureus Bacteraemia
- Being tested
- direct thrombin inhibition, enoxaparin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
direct thrombin inhibitionDrug
Also called dabigatran, argatroban
enoxaparinDrug
Also called clexane
| Study group | Role | What they receive |
|---|---|---|
| direct thrombin inhibition | Experimental | dabigatran 110 mg BID, po argatroban (0.5 - 1 µg/kg/min) if peroral therapy is not possible Receives: Drug: direct thrombin inhibition |
| enoxaparin | Active comparator | enoxaparin 40 mg od, sc Receives: Drug: enoxaparin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Safety Outcome is the occurence of clinically-relevant bleeding events
Measured: 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
as documented with a PET-CTscan in eligible patients on D7-10 or clinically-overt metastatic infectious foci
Measured: From randomization until month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2013 (estimated)
- Study startJan 2013
- Primary completionApr 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Staphylococcus Aureus BacteraemiaStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peter Verhamme, Universitaire Ziekenhuizen KU Leuven
- Investigators
- Peter Verhamme, Doctor, Principal investigator, Bloedings-en vaatziekten, UZ Gasthuisberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01911624
- Sponsor's protocol ID
- S54881
- Status last verified
- Jul 2016
- First submitted
- 14 Jun 2013
- Last updated
- 13 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Direct Thrombin Inhibitors Versus LMWH in Staphylococcus Aureus Bacteraemia. A Prospective Randomized Controlled Academic Single-centre Feasibility Study.
- ClinicalTrials.gov ID
- NCT01911624
- Acronym / sponsor ID
- S54881
- Conditions
- Staphylococcus Aureus Bacteraemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Apr 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 30 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| direct thrombin inhibition | Experimental | Drug: direct thrombin inhibitiondabigatran 110 mg BID, po argatroban (0.5 - 1 µg/kg/min) if peroral therapy is not possible |
| enoxaparin | Active comparator | Drug: enoxaparinenoxaparin 40 mg od, sc |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Positive blood culture for staphylococcus aureus
- Symptoms or signs of infection
- Indication for thromboprophylaxis
Key exclusion criteria (5 listed)
- Contraindication for thromboprophylaxis
- Significant active bleeding or risk of excessive bleeding
- Heparin-induced thrombocytopenia
- Severe liver and kidney disease
- Pregnancy and lactation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| direct thrombin inhibitionAlso: dabigatran, argatroban | Drug | direct thrombin inhibition |
| enoxaparinAlso: clexane | Drug | enoxaparin |
Primary outcome
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
1 secondary outcome
The primary efficacy outcome is the occurence of metastatic infection
Time frame: From randomization until month 3
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2016.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Verhamme, Doctor principal investigator
Bloedings-en vaatziekten, UZ Gasthuisberg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing direct thrombin inhibition and enoxaparin in people with Staphylococcus Aureus Bacteraemia, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2016.