Direct Thrombin Inhibitors Versus LMWH in Staphylococcus Aureus Bacteraemia

NCT01911624 | Completed Phase 2

• 1 other identifier: S54881
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

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.

Conditions

Staphylococcus Aureus Bacteraemia

Outcome Measures

Primary Outcomes (1)

• Primary Safety Outcome is the occurence of clinically-relevant bleeding events

  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

  From randomization until month 3

Other Outcomes (3)

• Laboratory markers of coagulation

  From randomization until D7-10

• Laboratory markers of inflammation

  From randomization until D7-10

• Clinical outcomes after S. aureus bacteremia

  From randomization until M3

Study Arms (2)

direct thrombin inhibition

EXPERIMENTAL

dabigatran 110 mg BID, po argatroban (0.5 - 1 µg/kg/min) if peroral therapy is not possible

Drug: direct thrombin inhibition

enoxaparin

ACTIVE COMPARATOR

enoxaparin 40 mg od, sc

Drug: enoxaparin

Interventions

direct thrombin inhibition DRUG

Also known as: dabigatran, argatroban

direct thrombin inhibition

enoxaparin DRUG

Also known as: clexane

enoxaparin

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Positive blood culture for staphylococcus aureus
• Symptoms or signs of infection
• Indication for thromboprophylaxis

You may not qualify if:

• Contraindication for thromboprophylaxis
• Significant active bleeding or risk of excessive bleeding
• Heparin-induced thrombocytopenia
• Severe liver and kidney disease
• Pregnancy and lactation.

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (1)

KUleuven/UZ Gasthuisberg

Leuven, 3000, Belgium

Location

MeSH Terms

Interventions

Dabigatran; argatroban; Enoxaparin

Intervention Hierarchy (Ancestors)

Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heparin, Low-Molecular-Weight; Heparin; Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Officials

• Peter Verhamme, Doctor

  Bloedings-en vaatziekten, UZ Gasthuisberg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: June 14, 2013
• First Posted: July 30, 2013
• Study Start: January 1, 2013
• Primary Completion: April 1, 2016
• Study Completion: July 1, 2016
• Last Updated: July 13, 2016

Record last verified: 2016-07

Locations

BE (1)