Clinical trial Recruiting at 21 sites Phase 4 Interventional Ages 18 and up

Comparing durations of antibiotic use after cardiac surgery

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

Run by Monash University · NCT05447559 · Data updated 2026-11-12

This study is testing how long to give antibiotics after heart surgery to see which duration best prevents infections.

Quick facts

PhasePhase 4
Study typeInterventional
Ages18 Years and up
SexAll
Enrollment9180 (estimated)
SponsorMonash University
Academic / other
Locations27 sites (Dallas, Texas and 26 other locations)
StatusRecruiting
StartedFebruary 7, 2023
Main results expectedDecember 2027
Study endsJune 2028
Registry record updatedMarch 25, 2026
Trial IDNCT05447559 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adult patients undergoing cardiac surgery involving a median sternotomy.

Probably not a fit

Patients under 18, those with severe comorbidities, or specific infections or allergies may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicentre, adaptive, double-blind, three-arm, placebo-controlled, randomised clinical trial aims to evaluate the effectiveness of different durations of intravenous cefazolin prophylaxis in preventing surgical site infections (SSI) in patients undergoing cardiac surgery. Participants will be assigned to one of three groups: receiving prophylaxis only during surgery, for 24 hours post-surgery, or for 48 hours post-surgery. The study will assess the incidence of SSI, healthcare-associated infections, and the economic and microbiological impacts of these different prophylaxis durations.

Why it matters

Potential benefit: If successful, this study could optimize antibiotic use and reduce the incidence of infections in cardiac surgery patients.

How similar studies have gone: Previous studies have shown varying success with antibiotic prophylaxis durations, making this approach both relevant and necessary for further exploration.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

\- Adult patients undergoing cardiac surgery involving a median sternotomy

Exclusion Criteria:

* 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's running

  • Westmead Hospital
    Sydney, New South Wales, Australia
    Recruiting
  • The Prince Charles Hospital
    Brisbane, Queensland, Australia
    Recruiting
  • Princess Alexandra Hospital
    Brisbane, Queensland, Australia
    Recruiting
  • Royal Adelaide Hospital
    Adelaide, South Australia, Australia
    Recruiting
  • Flinders Medical Centre
    Adelaide, South Australia, Australia
    Recruiting
  • Flinders Private
    Adelaide, South Australia, Australia
    Recruiting
Show 21 more locations
  • Royal Hobart Hospital
    Hobart, Tasmania, Australia
    Recruiting
  • The Alfred Hospital
    Melbourne, Victoria, Australia
    Recruiting
  • The Royal Melbourne Hospital
    Melbourne, Victoria, Australia
    Recruiting
  • Austin Health
    Melbourne, Victoria, Australia
    Recruiting
  • Epworth HealthCare
    Melbourne, Victoria, Australia
    Recruiting
  • Cabrini Health
    Melbourne, Victoria, Australia
    Recruiting
  • Victorian Heart Hospital
    Melbourne, Victoria, Australia
    Recruiting
  • St John of God Subiaco Hospital
    Perth, Western Australia, Australia
    Recruiting
  • Fiona Stanley Hospital
    Perth, Western Australia, Australia
    Recruiting
  • St Vincent's Hospital
    Melbourne, Australia
    Recruiting
  • Halifax Infirmary
    Halifax, Nova Scotia, Canada
    Recruiting
  • Ijn
    Kuala Lumpur, Malaysia
    Recruiting
  • Christchurch Hospital
    Christchurch, New Zealand
    Recruiting
  • Waikato Hospital
    Hamilton, New Zealand
    Recruiting
  • Wellington Hospital
    Wellington, New Zealand
    Recruiting
  • UT Southwestern Medical Centre
    Dallas, Texas, United States
    Not yet recruiting
  • St George Hospital
    Sydney, New South Wales, Australia
    Active not recruiting
  • St Andrew's War Memorial Hospital
    Brisbane, Queensland, Australia
    Active not recruiting
  • Sir Charles Gairdner
    Nedlands, Western Australia, Australia
    Not yet recruiting
  • Ummc
    Kuala Lumpur, Malaysia
    Not yet recruiting
  • Wakefield Hospital
    Wellington, New Zealand
    Not yet recruiting

Study contacts

  • Principal investigator: Trisha Peel, MBBS GradCertRes FRACP PhD — Monash University
  • Study coordinator: Paige Druce, MSc(Epi)
  • Email: paige.druce@monash.edu
  • Phone: 9903 0016

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.