Duration of Cardiac Antimicrobial Prophylaxis Outcomes Study — CALIPSO  

Surgical Site Infection Clinical Trial

Official title: Multicentre, Adaptive, Double-blind, Three-arm, Placebo-controlled, Noninferiority Trial Examining Antimicrobial Prophylaxis Duration in Cardiac Surgery

Status Recruiting

Clinical Trial 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

Clinical Trial 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 hours postoperatively Arm C Administration of prophylaxis in intraoperative plus for 48 hours postoperatively ;

Related Conditions & MeSH terms

• Surgical Site Infection
• Surgical Wound Infection

• NCT number: NCT05447559
• Study type: Interventional
• Source: Monash University
• Contact: Paige Druce, MSc(Epi)
• Phone: 9903 0016
• Email: paige.druce@monash.edu
• Status: Recruiting
• Phase: Phase 4
• Start date: February 7, 2023
• Completion date: June 2027