Professor Trisha Peel (CIA) and Professor Paul Myles (CIB) (Monash University and Alfred Health)
Please email Paige Druce if you are interested in being involved, or would like any further information about CALIPSO.
The start-up meeting was held at the ANZCA CTN workshop in August 2022. To obtain a copy of the recording, email Paige Druce.
The CALIPSO trial is a multicentre, adaptive, pragmatic, double-blind, three-arm, placebo-controlled, randomised, non-inferiority clinical trial comparing the incidence of surgical site infection 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.
Adult patients scheduled for cardiac surgery involving a median sternotomy.
A bolus of study drug (2g cefazolin or matched placebo) administered every 8-hours following the preoperative dose (time=0) for a total of five postoperative doses.
Incidence of surgical site infection.
Clostridioides difficile infection, other healthcare associated infections (pneumonia, blood stream infection and urinary tract infection), health economic endpoints (days alive and at home at 30, 90 and 180 days after surgery, direct health care costs, Quality of life data (EQ-5D-5L) at 180 days), microbiological impact.
Antimicrobial hypersensitivity reactions, all-cause mortality at 180 days, surgical site infections due to drug-resistant infections (defined as resistance to cefazolin) and, acute kidney injury.
Medical Research Future Fund grant $A7,979,999.10 (2022-2027)
A/Prof Trisha Peel
Dr Andrew Stewardson
Ms Paige Druce
Ms Sarah Astbury
Monash University, Melbourne
Alfred Health, Melbourne
Australian and New Zealand College of Anaesthetists Clinical Trials Network (ANZCA CTN)
Australian and New Zealand Intensive Care Society Clincal Trials Group (ANZICS CTG)
The Australasian Society for Infectious Diseases (ASID)
The Australian and New Zealand Society of Cardiac and Thoracic Surgeons (ANZSCTS)
The CALIPSO trial has received ethics approval for nine sites who are currently in start-up phase in Australia, with many more sites across Australia and overseas to be included in the near future. We look forward to activating sites from January 2023.