Multicentre, Adaptive, Double-blind, Three-arm, Placebo-controlled, Noninferiority Trial Examining Antimicrobial Prophylaxis Duration in Cardiac Surgery
Monash University
Summary
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
Description
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 h…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: \- Adult patients undergoing cardiac surgery involving a median sternotomy Exclusion Criteria: * 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…
Interventions
- DrugCefazolin
Intravenous administration of 2 g cefazolin
- DrugWater for injection
Intravenous administration of 10mL sterile water for injection
Locations (27)
- UT Southwestern Medical CentreDallas, Texas
- Westmead HospitalSydney, New South Wales
- St George HospitalSydney, New South Wales
- The Prince Charles HospitalBrisbane, Queensland
- Princess Alexandra HospitalBrisbane, Queensland
- St Andrew's War Memorial HospitalBrisbane, Queensland