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NCT01080963 Clinical Trial

Daptomycin as Antibiotic Prophylaxis of Sternal Wound Infections

Wound Infection Clinical Trial

— DaPro  

Official title:
Prospective Randomised Study of Daptomycin as Antibiotic Prophylaxis of Sternal Wound Infections After Median Sternotomy

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01080963
Other study ID # CCBC134ADAPRO
Secondary ID 2007-004611-61
Status Completed
Phase Phase 4
First received March 4, 2010
Last updated April 16, 2012
Start date November 2008
Est. completion date March 2012

Study information
Verified date April 2012
Source Hannover Medical School
Contact n/a
Is FDA regulated No
Health authority Germany: Federal Institute for Drugs and Medical Devices
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 650
Est. completion date March 2012
Est. primary completion date March 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility 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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Daptomycin
one infusion of 350 mg intraoperatively after disconnection from the heart-lung machine as an add-on to standard antibiotic prophylaxis
• Cefuroxime
1500 mg intravenous 30min preoperatively during anesthesia and 1500 mg intravenous intraoperatively after disconnection from the heart-lung machine

Locations
Country Name City State
Germany Hannover Medical School, Department of Cardiothoracic, Transplant and Vascular surgery Hannover

Sponsors (2)
Lead Sponsor Collaborator
Hannover Medical School Novartis

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 No
Secondary Incidence of sternal wound infections at day 30 after cardiac surgery day 30 No
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