Optimal duration of antibiotic therapy to prevent infections in patients undergoing cardiac surgery

Optimal duration of antibiotic therapy to prevent infections in patients undergoing cardiac surgery

 

CALIPSO trial: The Duration of Cardiac Antimicrobial Prophylaxis Outcomes Study

CALIPSO is a large (n=9,000) five year, multicentre, adaptive, pragmatic, double-blind, three-arm, placebo-controlled, randomised, non-inferiority clinical trial examining the optimal duration of antibiotic therapy to prevent infections in patients undergoing cardiac surgery.

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 team is led by Associate Professor Trisha Peel, and founding Chair of the ANZCA CTN Professor Paul Myles. The trial is funded by a $7.9 million grant from the Medical Research Future Fund.

Please email Paige Druce if you are at all interested in being involved, with your contact details and any questions.

Principal investigators

Associate Professor Trisha Peel (CIA) and Professor Paul Myles (CIB) (Monash University and Alfred Health)

Expression of Interest

Please email Paige Druce if you are interested in being involved, or would like any further information about CALIPSO.

Start-up meeting

The start-up meeting will be held at the ANZCA CTN workshop in August. 

 

Trial summary

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
9000 patients.

Study duration
Five years.

Funding

Medical Research Future Fund grant $A7,979,999.10 (2022-2027)

Operations Committee

A/Prof Trisha Peel
Dr Andrew Stewardson
Ms Paige Druce
Ms Sarah Astbury

Collaborators

Monash University, Melbourne
Alfred Health, Melbourne
Australian and New Zealand College of Anaesthetists Clinical Trials Network (ANZCA CTN)

Last updated 10:59 6.04.2022