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Daptomycin as Antibiotic Prophylaxis of Sternal Wound Infections (DaPro)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01080963
Recruitment Status : Completed
First Posted : March 5, 2010
Last Update Posted : April 17, 2012
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Wound Infection Drug: Daptomycin Drug: Cefuroxime Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 650 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective Randomised Study of Daptomycin as Antibiotic Prophylaxis of Sternal Wound Infections After Median Sternotomy
Study Start Date : November 2008
Primary Completion Date : March 2012
Study Completion Date : March 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: Daptomycin 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
Active Comparator: Cefuroxime Drug: Cefuroxime
1500 mg intravenous 30min preoperatively during anesthesia and 1500 mg intravenous intraoperatively after disconnection from the heart-lung machine


Outcome Measures

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Incidence of sternal wound infections at day 30 after cardiac surgery [ Time Frame: day 30 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01080963


Locations
Germany
Hannover Medical School, Department of Cardiothoracic, Transplant and Vascular surgery
Hannover, Germany
Sponsors and Collaborators
Hannover Medical School
Novartis
Investigators
Principal Investigator: Martin Strueber, Dr. Hannover Medical School
More Information

Responsible Party: Martin Strueber, Martin Strueber, MD, Hannover Medical School
ClinicalTrials.gov Identifier: NCT01080963     History of Changes
Other Study ID Numbers: CCBC134ADAPRO
2007-004611-61 ( EudraCT Number )
First Posted: March 5, 2010    Key Record Dates
Last Update Posted: April 17, 2012
Last Verified: April 2012

Keywords provided by Martin Strueber, Hannover Medical School:
Prophylaxis
Antibiotic
Sternotomy
Heart-Lung Machine

Additional relevant MeSH terms:
Infection
Communicable Diseases
Wounds and Injuries
Wound Infection
Anti-Bacterial Agents
Daptomycin
Cefuroxime
Cefuroxime axetil
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents