Duration of Cardiac Antimicrobial Prophylaxis Outcomes Study

Recruiting now · Phase 4 · Has a placebo group

Conditions studied: Surgical Site Infection

In brief

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

Key facts

Study ID

NCT05447559

Run by

Monash University

People needed

9180

Starts

2023-02-07

Expected to finish

2028-06-01

Last updated by the study team

2026-03-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adult patients undergoing cardiac surgery involving a median sternotomy

You may not qualify if…

• Age <18 years
• American Society of Anesthesiology (ASA) 5
• Subjects with GFR <40mL/min/1.73m2 or those requiring continuous renal replacement therapy, haemodialysis or peritoneal dialysis
• Surgery for suspected or proven endocarditis or deep sternal wound infection
• Documented cefazolin hypersensitivity
• Documented methicillin resistant Staphylococcus aureus (MRSA) colonisation or infection in the 12-months prior to index surgery
• Cardiac transplantation
• Procedures involving insertion ventricular assist device or mechanical circulatory support device
• Procedures not involving a median sternotomy
• Patients previously enrolled and randomised to the CALIPSO trial

Where it is running

• Wellington Hospital — Wellington, New Zealand (enrolling)
• Westmead Hospital — Sydney, New South Wales, Australia (enrolling)
• Fiona Stanley Hospital — Perth, Western Australia, Australia (enrolling)
• St Vincent's Hospital — Melbourne, Australia (enrolling)
• Halifax Infirmary — Halifax, Nova Scotia, Canada (enrolling)
• IJN — Kuala Lumpur, Malaysia (enrolling)
• Christchurch Hospital — Christchurch, New Zealand (enrolling)
• Waikato Hospital — Hamilton, New Zealand (enrolling)
• The Prince Charles Hospital — Brisbane, Queensland, Australia (enrolling)
• Princess Alexandra Hospital — Brisbane, Queensland, Australia (enrolling)
• Royal Adelaide Hospital — Adelaide, South Australia, Australia (enrolling)
• Flinders Medical Centre — Adelaide, South Australia, Australia (enrolling)
• Flinders Private — Adelaide, South Australia, Australia (enrolling)
• Royal Hobart Hospital — Hobart, Tasmania, Australia (enrolling)
• The Alfred Hospital — Melbourne, Victoria, Australia (enrolling)
• The Royal Melbourne Hospital — Melbourne, Victoria, Australia (enrolling)
• Austin Health — Melbourne, Victoria, Australia (enrolling)
• Epworth HealthCare — Melbourne, Victoria, Australia (enrolling)
• Cabrini Health — Melbourne, Victoria, Australia (enrolling)
• Victorian Heart Hospital — Melbourne, Victoria, Australia (enrolling)
• St John of God Subiaco Hospital — Perth, Western Australia, Australia (enrolling)
• St George Hospital — Sydney, New South Wales, Australia
• Sir Charles Gairdner — Nedlands, Western Australia, Australia
• Wakefield Hospital — Wellington, New Zealand
• St Andrew's War Memorial Hospital — Brisbane, Queensland, Australia

Full record on ClinicalTrials.gov

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