Duration of Cardiac Antimicrobial Prophylaxis Outcomes Study

Last updated: March 22, 2026
Sponsor: Monash University
Overall Status: Active - Recruiting

Phase

4

Condition

N/A

Treatment

Cefazolin

Water for injection

Clinical Study ID

NCT05447559
228/22
  • Ages > 18
  • All Genders

Study 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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Adult patients undergoing cardiac surgery involving a median sternotomy

Exclusion

Exclusion Criteria:

  • Age <18 years

  • American Society of Anesthesiology (ASA) 5

  • Subjects with GFR <40mL/min/1.73m2 or those requiring continuous renal replacementtherapy, 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 orinfection in the 12-months prior to index surgery

  • Cardiac transplantation

  • Procedures involving insertion ventricular assist device or mechanical circulatorysupport device

  • Procedures not involving a median sternotomy

  • Patients previously enrolled and randomised to the CALIPSO trial

Study Design

Total Participants: 9180
Treatment Group(s): 2
Primary Treatment: Cefazolin
Phase: 4
Study Start date:
February 07, 2023
Estimated Completion Date:
June 30, 2028

Study 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

Connect with a study center

  • St George Hospital

    Sydney, New South Wales 2217
    Australia

    Site Not Available

  • Westmead Hospital

    Sydney, New South Wales 2145
    Australia

    Active - Recruiting

  • Princess Alexandra Hospital

    Brisbane, Queensland 4102
    Australia

    Active - Recruiting

  • St Andrew's War Memorial Hospital

    Brisbane, Queensland
    Australia

    Site Not Available

  • The Prince Charles Hospital

    Brisbane, Queensland 4032
    Australia

    Active - Recruiting

  • Flinders Medical Centre

    Adelaide, South Australia 5042
    Australia

    Active - Recruiting

  • Flinders Private

    Adelaide, South Australia 5042
    Australia

    Active - Recruiting

  • Royal Adelaide Hospital

    Adelaide, South Australia 5000
    Australia

    Active - Recruiting

  • Royal Hobart Hospital

    Hobart, Tasmania 7000
    Australia

    Active - Recruiting

  • Austin Health

    Melbourne, Victoria 3084
    Australia

    Active - Recruiting

  • Cabrini Health

    Melbourne, Victoria 3144
    Australia

    Active - Recruiting

  • Epworth Eastern HealthCare

    Melbourne, Victoria 3128
    Australia

    Site Not Available

  • Epworth HealthCare

    Melbourne, Victoria 3121
    Australia

    Active - Recruiting

  • Melbourne Private Hospital

    Melbourne, Victoria 3050
    Australia

    Site Not Available

  • Monash Health

    Melbourne, Victoria 3168
    Australia

    Active - Recruiting

  • The Alfred Hospital

    Melbourne, Victoria 3004
    Australia

    Active - Recruiting

  • The Royal Melbourne Hospital

    Melbourne, Victoria 3050
    Australia

    Active - Recruiting

  • Victorian Heart Hospital

    Melbourne, Victoria 3168
    Australia

    Active - Recruiting

  • Sir Charles Gairdner

    Nedlands, Western Australia
    Australia

    Site Not Available

  • Fiona Stanley Hospital

    Perth, Western Australia
    Australia

    Active - Recruiting

  • St John of God Subiaco Hospital

    Perth, Western Australia 6008
    Australia

    Active - Recruiting

  • St Vincent's Hospital

    Melbourne,
    Australia

    Active - Recruiting

  • Halifax Infirmary

    Halifax, Nova Scotia
    Canada

    Active - Recruiting

  • IJN

    Kuala Lumpur,
    Malaysia

    Active - Recruiting

  • UMMC

    Kuala Lumpur,
    Malaysia

    Site Not Available

  • Christchurch Hospital

    Christchurch,
    New Zealand

    Active - Recruiting

  • Waikato Hospital

    Hamilton, 3204
    New Zealand

    Active - Recruiting

  • Wakefield Hospital

    Wellington,
    New Zealand

    Site Not Available

  • Wellington Hospital

    Wellington,
    New Zealand

    Active - Recruiting

  • UT Southwestern Medical Centre

    Dallas, Texas 75390
    United States

    Site Not Available

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