IDC 56: 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
试验速览
- 阶段
- 4 期
- 入组人数
- 500
- 试验地点
- 2
- 主要终点
- Surgical site infection
研究概览
简要总结
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.
详细描述
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. Study participants will be enrolled from 2 populations of patients; those undergoing cardiothoracic surgery with sternotomy and those undergoing prosthetic joint replacement of either hip or knee.
Subjects will be identified by the primary surgical service. Adult subjects 18 years and older will be notified of the study and if agreeable will be interviewed by a study coordinator who will explain the study and study procedures and determine eligibility. Informed consent will be obtained from potential participants. Enrollment and consent may be obtained up to seven days prior to surgery.
Consented participants will have a detailed history performed with particular reference to prior surgical infections, risk factors such as diabetes, smoking, prior skin infections and obesity. Participants will undergo a physical examination. Patients will be assessed for nares colonization with methicillin-resistant Staphylococcus aureus (MRSA) as per the primary surgeon's standard procedure. Patients identified as positive for MRSA colonization will be decolonized with mupirocin. Female participants will have a serum beta-human chorionic gonadotrophin (HCG) assay performed to exclude pregnancy.
Consented participants will be randomized 2:1 to receive either ceftaroline or cefazolin/vancomycin, the current regimen for high risk individuals. Randomization will be performed by a blinded individual using a randomization program. Within each group, participants will be allocated in the 2:1 ratio.
On the day of surgery, all patients will be evaluated for changes in medical history, vital signs recorded and bilateral nares swabs obtained for Staphylococcal screening for both MRSA and methicillin-sensitive Staphylococcus aureus (MSSA) carriage. All patients will receive pre-operative toweling of the operative site with chlorhexidine, and a surgical skin preparation of chlorhexidine/alcohol (Duraprep).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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/m
- •Concurrent antibiotics
研究组 & 干预措施
Ceftaroline
Experimental comparator for surgical peri-operative prophylaxis for procedures at increased risk if MRSA infection
干预措施: Ceftaroline (Drug)
Cefazolin / Vancomycin
Standard of care comparator for surgical peri-operative prophylaxis for procedures at increased risk if MRSA infection
干预措施: Cefazolin / Vancomycin (Drug)
结局指标
主要结局
Surgical site infection
时间窗: 30 days
Surgical site infection rates at either the primary surgical site or any remote surgical site
次要结局
- Other infection(30 days)
- Drug intolerance(30 days)
- Repeat surgery(30 days)
研究者
George Smulian
Professor
University of Cincinnati