drugset / Trial / NCT02307006
The Use of Ceftaroline as Surgical Prophylaxis in Surgery With Risk of MRSA Infection
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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.