drugset / Trial / NCT02307006

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

NCT02307006

RandomizedParallel-groupTriple-blindPrevention

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.

Timeline

Start
2015-01
Primary completion
2016-12
Completion
2017-06

Drugs

EvaluationDrugModalityDoseRoute
Comparator Cefazolin Small molecule 25 mg/kg Intravenous
Subject Ceftaroline Other / unclassified 400 mg Intravenous
Subject Ceftaroline Other / unclassified 600 mg Intravenous
Comparator Vancomycin Other / unclassified 15 mg/kg Intravenous

Indications

No indication recorded.