Duration of Cardiac Antimicrobial Prophylaxis Outcomes Study (CALIPSO)

March 22, 2026 updated by: Trisha Nicole Peel, Monash University

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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

Study Type

Interventional

Enrollment (Estimated)

9180

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Australia
      • Melbourne, Australia
        • Recruiting
        • St Vincent's Hospital
        • Contact:
        • Principal Investigator:
          • David Scott
    • New South Wales
      • Sydney, New South Wales, Australia, 2145
        • Recruiting
        • Westmead Hospital
        • Contact:
          • Louise Cope
        • Principal Investigator:
          • Alison Williams
      • Sydney, New South Wales, Australia, 2217
        • Active, not recruiting
        • St George Hospital
    • Queensland
      • Brisbane, Queensland, Australia, 4102
      • Brisbane, Queensland, Australia, 4032
        • Recruiting
        • The Prince Charles Hospital
        • Contact:
        • Principal Investigator:
          • Mbakise Matebele
      • Brisbane, Queensland, Australia
        • Active, not recruiting
        • St Andrew's War Memorial Hospital
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Recruiting
        • Royal Adelaide Hospital
        • Contact:
        • Principal Investigator:
          • Kate Drummond
      • Adelaide, South Australia, Australia, 5042
        • Recruiting
        • Flinders Medical Centre
        • Contact:
        • Principal Investigator:
          • Rob Baker
      • Adelaide, South Australia, Australia, 5042
        • Recruiting
        • Flinders Private
        • Contact:
        • Principal Investigator:
          • Rob Baker
    • Tasmania
      • Hobart, Tasmania, Australia, 7000
    • Victoria
      • Melbourne, Victoria, Australia, 3004
        • Recruiting
        • The Alfred Hospital
        • Contact:
        • Principal Investigator:
          • Silvana Marasco
      • Melbourne, Victoria, Australia, 3050
        • Recruiting
        • The Royal Melbourne Hospital
        • Principal Investigator:
          • Alistair Royse
        • Contact:
      • Melbourne, Victoria, Australia, 3084
      • Melbourne, Victoria, Australia, 3168
        • Recruiting
        • Victorian Heart Hospital
        • Contact:
        • Principal Investigator:
          • Julian Smith
      • Melbourne, Victoria, Australia, 3144
      • Melbourne, Victoria, Australia, 3121
    • Western Australia
      • Nedlands, Western Australia, Australia
        • Not yet recruiting
        • Sir Charles Gairdner
        • Contact:
        • Principal Investigator:
          • James Preuss
      • Perth, Western Australia, Australia
        • Recruiting
        • Fiona Stanley Hospital
        • Contact:
        • Principal Investigator:
          • Ulrich Stock, Prof
      • Perth, Western Australia, Australia, 6008
        • Recruiting
        • St John of God Subiaco Hospital
        • Contact:
        • Principal Investigator:
          • Tomas Corcoran
  • Canada
    • Nova Scotia
      • Halifax, Nova Scotia, Canada
        • Recruiting
        • Halifax Infirmary
        • Contact:
          • Dr Neville Burke
  • Malaysia
      • Kuala Lumpur, Malaysia
        • Recruiting
        • IJN
        • Contact:
          • Dr Chong Kee Soon
      • Kuala Lumpur, Malaysia
        • Not yet recruiting
        • UMMC
        • Contact:
          • Prof Sasheela Sri La Sri Ponnampalavanar
  • New Zealand
      • Christchurch, New Zealand
        • Recruiting
        • Christchurch Hospital
        • Contact:
        • Principal Investigator:
          • Jay Ritzema-Carter
      • Hamilton, New Zealand, 3204
      • Wellington, New Zealand
        • Recruiting
        • Wellington Hospital
        • Contact:
        • Principal Investigator:
          • Daniel Frei
      • Wellington, New Zealand
        • Not yet recruiting
        • Wakefield Hospital
        • Contact:
          • Leanlove Navarra
  • United States
    • Texas
      • Dallas, Texas, United States, 75390
        • Not yet recruiting
        • UT SOUTHWESTERN medical CENTRE
        • Contact:
          • Dr Markus Velten

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Intraoperative only Surgical Antimicrobial Prophylaxis Arm
Placebo administered every 8-hours following the preoperative dose (time=0) for a total of five postoperative doses
Drug: Water for injection
Intravenous administration of 10mL sterile water for injection
Other: Intraoperative and 24-hours Postoperative Surgical Antimicrobial Prophylaxis Arm
Cefazolin (2g) administered 8-hourly following the preoperative dose (time=0) for two doses then placebo 8-hourly for three doses (total of 5 postoperative doses of cefazolin/placebo)
Drug: Water for injection
Intravenous administration of 10mL sterile water for injection
Drug: Cefazolin
Intravenous administration of 2 g cefazolin
Active Comparator: Intraoperative and 48-hours Postoperative Surgical Antimicrobial Prophylaxis Arm
Cefazolin (2g) administered every 8-hours following the preoperative dose (time=0) for a total of five postoperative doses
Drug: Cefazolin
Intravenous administration of 2 g cefazolin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of surgical site infection
Time Frame: 90 days from index surgery
Surgical site infection according to CDC / NHSN definition
90 days from index surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Clostridioides difficile infection
Time Frame: 30 days from index surgery
Clostridioides difficile infection according the CDC definitions
30 days from index surgery
Incidence of other health care association infections
Time Frame: From date of randomization until the date of discharge from the acute healthcare facility or date of death from any cause, whichever came first, assessed up to 30 days from index surgery
Composite of all other HCAIs (pneumonia, blood stream infection and urinary tract infection)
From date of randomization until the date of discharge from the acute healthcare facility or date of death from any cause, whichever came first, assessed up to 30 days from index surgery

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Antimicrobial hypersensitivity reactions
Time Frame: From date of randomization until the date of discharge from the acute healthcare facility or date of death from any cause, whichever came first, assessed up to 30 days from index surgery
Immediate (<48 hrs after exposure) or delayed (≥24 hrs after exposure) reaction to study drug
From date of randomization until the date of discharge from the acute healthcare facility or date of death from any cause, whichever came first, assessed up to 30 days from index surgery
All-cause mortality rate
Time Frame: 180 days from index surgery
Death reported up to 180 days from index cardiac surgery due to any cause.
180 days from index surgery
Incidence of acute kidney injury
Time Frame: From date of randomization until the date of discharge from the acute healthcare facility or date of death from any cause, whichever came first, assessed up to 30 days from index surgery
AKI will be defined according to the RIFLE criteria
From date of randomization until the date of discharge from the acute healthcare facility or date of death from any cause, whichever came first, assessed up to 30 days from index surgery
Incidence of surgical site infections due to drug-resistant infections
Time Frame: 90 days from index surgery
Surgical site infections due to drug-resistant infections (defined as resistance to cefazolin)
90 days from index surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Monash University

Collaborators

ANZCA CTN

Investigators

  • Principal Investigator: Trisha Peel, MBBS GradCertRes FRACP PhD, Monash University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 7, 2023

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

June 1, 2028

Study Registration Dates

First Submitted

June 27, 2022

First Submitted That Met QC Criteria

July 5, 2022

First Posted (Actual)

July 7, 2022

Study Record Updates

Last Update Posted (Actual)

March 25, 2026

Last Update Submitted That Met QC Criteria

March 22, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 228/22

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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