Back to resultsDaptomycin as Antibiotic Prophylaxis of Sternal Wound Infections (DaPro)
Primary Purpose
Wound Infection
Status
Completed
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
Daptomycin
Cefuroxime
Sponsored by
About this trial
This is an interventional treatment trial for Wound Infection focused on measuring Prophylaxis, Antibiotic, Sternotomy, Heart-Lung Machine
Eligibility 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
Sites / Locations
- Hannover Medical School, Department of Cardiothoracic, Transplant and Vascular surgery
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Daptomycin
Cefuroxime
Arm Description
Outcomes
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
Secondary Outcome Measures
Incidence of sternal wound infections at day 30 after cardiac surgery
Full Information
NCT ID
NCT01080963
First Posted
March 4, 2010
Last Updated
April 16, 2012
Sponsor
Hannover Medical School
Collaborators
Novartis
1. Study Identification
Unique Protocol Identification Number
NCT01080963
Brief Title
Daptomycin as Antibiotic Prophylaxis of Sternal Wound Infections
Acronym
DaPro
Official Title
Prospective Randomised Study of Daptomycin as Antibiotic Prophylaxis of Sternal Wound Infections After Median Sternotomy
Study Type
Interventional
2. Study Status
Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
November 2008 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
March 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hannover Medical School
Collaborators
Novartis
4. Oversight
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wound Infection
Keywords
Prophylaxis, Antibiotic, Sternotomy, Heart-Lung Machine
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
650 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Daptomycin
Arm Type
Active Comparator
Arm Title
Cefuroxime
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Daptomycin
Other Intervention Name(s)
Cubicin
Intervention Description
one infusion of 350 mg intraoperatively after disconnection from the heart-lung machine as an add-on to standard antibiotic prophylaxis
Intervention Type
Drug
Intervention Name(s)
Cefuroxime
Intervention Description
1500 mg intravenous 30min preoperatively during anesthesia and 1500 mg intravenous intraoperatively after disconnection from the heart-lung machine
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Incidence of sternal wound infections at day 30 after cardiac surgery
Time Frame
day 30
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin Strueber, Dr.
Organizational Affiliation
Hannover Medical School
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hannover Medical School, Department of Cardiothoracic, Transplant and Vascular surgery
City
Hannover
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Daptomycin as Antibiotic Prophylaxis of Sternal Wound Infections
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