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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Communicable Diseases
Infection
Wound Infection
Wounds and Injuries
Anti-Bacterial Agents
Antibiotics, Antitubercular
Cefuroxime
Cefuroxime axetil
Daptomycin
Anti-Infective Agents
Antitubercular Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 30, 2014