The Use of Ceftaroline as Surgical Prophylaxis in Surgery With Risk of MRSA Infection

• Status: Unknown status
• Trial end date: 2017-06-01
• Target enrollment: 0
• Participant gender: All

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. Study participants will be enrolled from those undergoing cardiothoracic surgery involving sternotomy and those undergoing prosthetic joint replacement of either hip or knee. Consenting patients will be randomized 2:1 to receive either ceftaroline or cefazolin/vancomycin. This study will be blinded by the use of placebo vancomycin infusions and placebo cephalosporin infusions. The primary end point will be the development of a surgical site infection within 30 days of surgery.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Cincinnati
• Collaborator: Forest Laboratories
• Treatments: Cefazolin; Ceftaroline fosamil; Vancomycin

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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