Daptomycin as Antibiotic Prophylaxis of Sternal Wound Infections
DaPro
Prospective Randomised Study of Daptomycin as Antibiotic Prophylaxis of Sternal Wound Infections After Median Sternotomy
2 other identifiers
interventional
650
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Nov 2008
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2008
CompletedFirst Submitted
Initial submission to the registry
March 4, 2010
CompletedFirst Posted
Study publicly available on registry
March 5, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2012
CompletedApril 17, 2012
April 1, 2012
3.3 years
March 4, 2010
April 16, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (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
day 30
Secondary Outcomes (1)
Incidence of sternal wound infections at day 30 after cardiac surgery
day 30
Study Arms (2)
Daptomycin
ACTIVE COMPARATORCefuroxime
ACTIVE COMPARATORInterventions
one infusion of 350 mg intraoperatively after disconnection from the heart-lung machine as an add-on to standard antibiotic prophylaxis
1500 mg intravenous 30min preoperatively during anesthesia and 1500 mg intravenous intraoperatively after disconnection from the heart-lung machine
Eligibility Criteria
You may qualify if:
- age between 18-80
- written informed consent (IC)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hannover Medical Schoollead
- Novartiscollaborator
Study Sites (1)
Hannover Medical School, Department of Cardiothoracic, Transplant and Vascular surgery
Hanover, Germany
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Martin Strueber, Dr.
Hannover Medical School
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Martin Strueber, MD
Study Record Dates
First Submitted
March 4, 2010
First Posted
March 5, 2010
Study Start
November 1, 2008
Primary Completion
March 1, 2012
Study Completion
March 1, 2012
Last Updated
April 17, 2012
Record last verified: 2012-04