The trial aims to 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.
The CALIPSO trial opened to recruitment in February 2023 and has since recruited over 1,591 patients at hospital sites across Australia and New Zealand. The trial is expanding internationally with ethics processes underway for sites in Italy (and elsewhere in Europe), Malaysia, Canada and the US.
Study summary
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.
Eligibility
Adult patients scheduled for cardiac surgery involving a median sternotomy.
Study intervention
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.
Primary endpoint
Incidence of surgical site infection.
Secondary endpoints
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.
Safety endpoints
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.
Sample size
9180 patients.
Study duration
Five years.
Medical Research Future Fund grant $A7,979,999.10 (2022-2027)
A/Prof Trisha Peel
Dr Andrew Stewardson
Ms Paige Druce
Ms Sarah Astbury
Ms Janine Roney
Monash University, Melbourne (Administering institution)
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 start-up meeting was held at the ANZCA CTN workshop in August 2022. To obtain a copy of the recording, email Paige Druce.
ClinicalTrials.gov Identifier: NCT03991481
| Australian sites |
| Alfred Health VIC |
| Austin Health VIC |
| Cabrini Hospital VIC |
| Epworth Richmond VIC |
| Fiona Stanley Hospital WA |
| Flinders Medical Centre SA |
| Flinders Private Hospital SA |
| Prince Charles Hospital QLD |
| Princess Alexandra Hospital QLD |
| Royal Adelaide Hospital SA |
| Royal Hobart Hospital TAS |
| Royal Melbourne Hospital VIC |
| SJOG Subiaco WA |
| Sir Charles Gairdner Hospital WA |
| St Andrew’s War Memorial Hospital QLD |
| St George Hospital NSW |
| St John of God Subiaco WA |
| St Vincent’s Hospital Melbourne VIC |
| The Victorian Heart Hospital VIC |
| Westmead Hospital NSW |
| New Zealand Hospitals |
| Christchurch Hospital |
| Waikato |
| Wellington Hospital |
Please email Paige Druce if you are interested in being involved, or would like any further information about CALIPSO.