Status:
UNKNOWN
The Use of Ceftaroline as Surgical Prophylaxis in Surgery With Risk of MRSA Infection
Lead Sponsor:
University of Cincinnati
Collaborating Sponsors:
Forest Laboratories
Conditions:
Surgical Site Infection
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The study is a randomized double-blinded study comparing ceftaroline to standard of care therapy with cefazolin and vancomycin as surgical prophylaxis for high risk orthopedic and cardiac surgeries. S...
Detailed Description
The study is a randomized double-blinded study comparing ceftaroline to standard of care therapy with cefazolin and vancomycin as surgical prophylaxis for high risk orthopedic and cardiac surgeries. S...
Eligibility Criteria
Inclusion
- Informed Consent
- Age - 18 years and older
- Patients undergoing either hip or knee arthroplasty or cardiac surgery with sternotomy
- Body mass index (BMI) between 18 and 30 kg/m2 inclusive.
- Female subjects must have a negative serum pregnancy test and be using appropriate contraception.
Exclusion
- Pregnancy
- Hypersensitivity or allergic reaction to any β-lactam antibiotic or vancomycin.
- Presence of cardiovascular shock,
- Receipt of chronic concomitant systemic corticosteroids, 40 mg of prednisone equivalent;
- Severe renal impairment (i.e. Creatinine clearance ≤ 30 mL/min);
- Significant hepatic impairment (i.e. known acute viral hepatitis, aspartate aminotransferase or alanine aminotransferase concentration 10-fold the upper limit of normal (ULN) or total bilirubin 3-fold the ULN or manifestations of end-stage liver disease, such as ascites or hepatic encephalopathy),
- Hematological impairment with current or anticipated neutropenia with less than 500 neutrophils/mm3 or thrombocytopenia with platelet count of 60 000 cells/mm3
- HIV infection which at the time of screening meets 2008 CDC criteria for AIDS.
- Patients undergoing revision surgery for infected prosthetic joint replacement.
- Body mass index (BMI) less than 18 or greater than 30 kg/m2.
- Concurrent antibiotics
Key Trial Info
Start Date :
January 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2017
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT02307006
Start Date
January 1 2015
End Date
June 1 2017
Last Update
December 2 2015
Active Locations (2)
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1
University of Cincinnati Medical Center
Cincinnati, Ohio, United States, 45219
2
West Chester Hospital
West Chester, Ohio, United States, 45069