Direct Thrombin Inhibitors Versus LMWH in Staphylococcus Aureus Bacteraemia

Staphylococcus Aureus Bacteraemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01911624
• Other study ID #: S54881
• Status: Completed
• Phase: Phase 2
• First received: June 14, 2013
• Last updated: July 11, 2016
• Start date: January 2013
• Est. completion date: July 2016

Study information

• Verified date: July 2016
• Source: Universitaire Ziekenhuizen Leuven
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicines and Health Products, FAMHP
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 94
• Est. completion date: July 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Bacteremia
• Staphylococcus Aureus Bacteraemia

Intervention

Drug:
• direct thrombin inhibition

• enoxaparin

Locations

Country	Name	City	State
Belgium	KUleuven/UZ Gasthuisberg	Leuven

Sponsors (1)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Laboratory markers of coagulation	D-dimeren, fibrinogen, APTT, PT dabigatran level or antiXa	From randomization until D7-10	No
Other	Laboratory markers of inflammation	CRP	From randomization until D7-10	No
Other	Clinical outcomes after S. aureus bacteremia		From randomization until M3	No
Primary	Primary Safety Outcome is the occurence of clinically-relevant bleeding events		From date of randomization up to end of study drug + 3 days	Yes
Secondary	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	From randomization until month 3	Yes