Multicentre, Adaptive, Double-blind, Three-arm, Placebo-controlled, Noninferiority Trial Examining Antimicrobial Prophylaxis Duration in Cardiac Surgery
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 9,180
- 试验地点
- 22
- 主要终点
- Incidence of surgical site infection
研究概览
简要总结
This multicentre, adaptive, pragmatic, double-blind, three-arm, placebo-controlled, randomised, non-inferiority clinical trial will compare the incidence of surgical site infection and other healthcare associated infections, health economic and microbiological impact after intraoperative only (Arm A), to 24 hours (Arm B) and, to 48 hours (Arm C) of IV cefazolin and placebo postoperative surgical antimicrobial prophylaxis in patients undergoing cardiac surgery
详细描述
This trial will evaluate the clinical effectiveness, health-economic outcomes and microbiological impact of intraoperative (only) compared with intraoperative plus postoperative prophylaxis durations in patients undergoing cardiac surgery.
CALIPSO, a multicentre, adaptive, double-blind, three-arm, placebo-controlled, phase IV, noninferiority trial will examine the incidence proportion of SSI following cardiac surgery. Our three-intervention trial will compare:
Arm A Administration of prophylaxis in intraoperative period only Arm B Administration of prophylaxis in intraoperative plus for 24 hours postoperatively Arm C Administration of prophylaxis in intraoperative plus for 48 hours postoperatively
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Participants, treating clinicians, all members of the research team including the study statistician will be blinded to treatment arm allocation.
Active treatment will consist of 2-grams cefazolin powder for injection. Placebo will consist of an identical empty vial. The commercial labels will be removed and a sheath placed over the vial. Amber-tinted syringes will be provided for drawing up and administration of cefazolin/placebo to mask study arm.
The vial containing cefazolin or placebo will be reconstituted in a minimum of 10 mL of sterile water for injections and administered in keeping with product information for cefazolin and / or local guidelines.
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
- •Adult patients undergoing cardiac surgery involving a median sternotomy
排除标准
- •Age <18 years
- •American Society of Anesthesiology (ASA) 5
- •Subjects with GFR <40mL/min/1.73m2 or those requiring continuous renal replacement therapy, haemodialysis or peritoneal dialysis
- •Surgery for suspected or proven endocarditis or deep sternal wound infection
- •Documented cefazolin hypersensitivity
- •Documented methicillin resistant Staphylococcus aureus (MRSA) colonisation or infection in the 12-months prior to index surgery
- •Cardiac transplantation
- •Procedures involving insertion ventricular assist device or mechanical circulatory support device
- •Procedures not involving a median sternotomy
- •Patients previously enrolled and randomised to the CALIPSO trial
研究组 & 干预措施
Intraoperative only Surgical Antimicrobial Prophylaxis Arm
Placebo administered every 8-hours following the preoperative dose (time=0) for a total of five postoperative doses
干预措施: Water for injection (Drug)
Intraoperative and 24-hours Postoperative Surgical Antimicrobial Prophylaxis Arm
Cefazolin (2g) administered 8-hourly following the preoperative dose (time=0) for two doses then placebo 8-hourly for three doses (total of 5 postoperative doses of cefazolin/placebo)
干预措施: Cefazolin (Drug)
Intraoperative and 24-hours Postoperative Surgical Antimicrobial Prophylaxis Arm
Cefazolin (2g) administered 8-hourly following the preoperative dose (time=0) for two doses then placebo 8-hourly for three doses (total of 5 postoperative doses of cefazolin/placebo)
干预措施: Water for injection (Drug)
Intraoperative and 48-hours Postoperative Surgical Antimicrobial Prophylaxis Arm
Cefazolin (2g) administered every 8-hours following the preoperative dose (time=0) for a total of five postoperative doses
干预措施: Cefazolin (Drug)
结局指标
主要结局
Incidence of surgical site infection
时间窗: 90 days from index surgery
Surgical site infection according to CDC / NHSN definition
次要结局
- Incidence of other health care association infections(From date of randomization until the date of discharge from the acute healthcare facility or date of death from any cause, whichever came first, assessed up to 30 days from index surgery)
- Incidence of Clostridioides difficile infection(30 days from index surgery)
研究者
Trisha Nicole Peel
Professor Trisha Peel
Monash University