ANZICS CTG Endorsed Study

CALIPSO

The Duration of Cardiac Antimicrobial Prophylaxis Outcomes Study: multicentre, adaptive, double-blind, three-arm, placebo-controlled, noninferiority trial examining antimicrobial prophylaxis duration in cardiac surgery

Study Description

We propose an adaptive, noninferiority trial comparing three durations of surgical antimicrobial prophylaxis in 9000 patients undergoing cardiac surgery. Our adaptive design allows for dropping of harmful arms. Our trial will examine if:

• Shorter prophylaxis durations are associated with a clinically acceptable low risk of surgical site infections (SSI), specifically:
• Intraoperatively only is noninferior to intraoperatively plus 24 hours postoperatively
• Intraoperatively only is noninferior to intraoperatively plus 48 hours postoperatively
• 24-hours postoperatively differs from 48-hours postoperatively
• The incidence of other healthcare associated infections (HCAI), including C. difficile are impacted by prophylaxis duration
• Longer durations of prophylaxis are associated with alterations to the normal microbiome and emergence of drug-resistant bacterial colonisation
• The relative cost-effectiveness of the different prophylaxis durations conducted from the healthcare perspective

Management Committee

Associate Professor Trisha Peel, Prof Paul Myles, Prof David McGiffin, Professor Julian Smith, Professor Silvana, Professor David Pilcher, Associate Professor Andrew Stewardson, Professor Anton Peleg, Professor Andrew Forbes, A/Professor Dennis Petrie, Dr Jessica Wisniewski, Dr Samuel Forster, Associate Professor Philip Russo, Ms Janine Roney, Ms Karen Goulding, Ms Paige Druce, Ms Sarah Astbury, Ms Phoebe McCracken, Dr Danielle Berkovic, Mr Jacob Goldstein

Administering Institution

Monash University

Sample Size

9180

Funding

MRFF

Reference

CTG2223-01

Contact

Trisha Peel (email)