Daptomycin as Antibiotic Prophylaxis of Sternal Wound Infections

Overview

The purpose of this study is to show that the incidence of sternal wound infections at day 30 after cardiac surgery is 50% lower with the additional use of Daptomycin on top of a standard antibiotic prophylaxis as compared to the standard antibiotic prophylaxis alone.

Full Title of Study: “Prospective Randomised Study of Daptomycin as Antibiotic Prophylaxis of Sternal Wound Infections After Median Sternotomy”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: March 2012

Interventions

  • Drug: Daptomycin
    • one infusion of 350 mg intraoperatively after disconnection from the heart-lung machine as an add-on to standard antibiotic prophylaxis
  • Drug: Cefuroxime
    • 1500 mg intravenous 30min preoperatively during anesthesia and 1500 mg intravenous intraoperatively after disconnection from the heart-lung machine

Arms, Groups and Cohorts

  • Active Comparator: Daptomycin
  • Active Comparator: Cefuroxime

Clinical Trial Outcome Measures

Primary Measures

  • Incidence of sternal wound infection is at least 50% lower if Daptomycin is used on top of a standard antibiotic prophylaxis as compared to the standard antibiotic prophylaxis alone
    • Time Frame: day 30

Secondary Measures

  • Incidence of sternal wound infections at day 30 after cardiac surgery
    • Time Frame: day 30

Participating in This Clinical Trial

Inclusion Criteria

  • age between 18-80
  • written informed consent (IC)

Exclusion Criteria

  • pregnant and lactating women
  • patients operated for a transplantation
  • patients with a increased myopathy risk
  • patients with a creatinine clearance < 30ml/min; patients on hemodialysis
  • patients after a previous sternotomy
  • treatment with any antibiotics 14 days prior study start
  • treatment with Daptomycin or Cefuroxime within 3 month prior study start

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Hannover Medical School
  • Collaborator
    • Novartis
  • Provider of Information About this Clinical Study
    • Principal Investigator: Martin Strueber, Martin Strueber, MD – Hannover Medical School
  • Overall Official(s)
    • Martin Strueber, Dr., Principal Investigator, Hannover Medical School

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