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Daptomycin as Antibiotic Prophylaxis of Sternal Wound Infections (DaPro)

This study has been completed.
Sponsor:
Collaborator:
Novartis
Information provided by (Responsible Party):
Martin Strueber, Hannover Medical School
ClinicalTrials.gov Identifier:
NCT01080963
First received: March 4, 2010
Last updated: April 16, 2012
Last verified: April 2012
History of Changes

March 4, 2010
April 16, 2012
November 2008
March 2012   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
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
Complete list of historical versions of study NCT01080963 on ClinicalTrials.gov Archive Site
Incidence of sternal wound infections at day 30 after cardiac surgery [ Time Frame: day 30 ] [ Designated as safety issue: No ]
  • Incidence of sternal wound infections at day 30 after cardiac surgery
  • Safety and tolerance of Daptomycin for prophylaxis
Not Provided
Not Provided
 
Daptomycin as Antibiotic Prophylaxis of Sternal Wound Infections
Prospective Randomised Study of Daptomycin as Antibiotic Prophylaxis of Sternal Wound Infections After Median Sternotomy

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.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Wound Infection
  • Drug: Daptomycin
    one infusion of 350 mg intraoperatively after disconnection from the heart-lung machine as an add-on to standard antibiotic prophylaxis
    Other Name: Cubicin
  • Drug: Cefuroxime
    1500 mg intravenous 30min preoperatively during anesthesia and 1500 mg intravenous intraoperatively after disconnection from the heart-lung machine
  • Active Comparator: Daptomycin
    Intervention: Drug: Daptomycin
  • Active Comparator: Cefuroxime
    Intervention: Drug: Cefuroxime
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
650
March 2012
March 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01080963
CCBC134ADAPRO, 2007-004611-61
Not Provided
Martin Strueber, Hannover Medical School
Hannover Medical School
Novartis
Principal Investigator: Martin Strueber, Dr. Hannover Medical School
Hannover Medical School
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP