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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
  Purpose

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 Intervention Phase
Wound Infection
 Drug: Daptomycin
Drug: Cefuroxime
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prospective Randomised Study of Daptomycin as Antibiotic Prophylaxis of Sternal Wound Infections After Median Sternotomy

Resource links provided by NLM:

MedlinePlus related topics: Antibiotics
U.S. FDA Resources

Further study details as provided by Hannover Medical School:

Primary Outcome 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Incidence of sternal wound infections at day 30 after cardiac surgery [ Time Frame: day 30 ] [ Designated as safety issue: No ]

Enrollment: 650
Study Start Date: November 2008
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: March 4, 2010
Last Updated: April 16, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

Additional relevant MeSH terms:
Wound Infection
Infection
Wounds and Injuries
Anti-Bacterial Agents
Cefuroxime
 Cefuroxime axetil
Daptomycin
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 17, 2013