Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05447559

Duration of Cardiac Antimicrobial Prophylaxis Outcomes Study

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

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Surgical Site Infection Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Surgical Wound Infection Wound Infection

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

St George Hospital, Sydney, New South Wales, Australia

Loading trial locations.

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cefazolin

Drug

Intravenous administration of 2 g cefazolin

Water for injection

Drug

Intravenous administration of 10mL sterile water for injection

Primary outcomes

  1. Incidence of surgical site infection

    Time frame: 90 days from index surgery

    Surgical site infection according to CDC / NHSN definition

Secondary outcomes

  1. Incidence of Clostridioides difficile infection

    Time frame: 30 days from index surgery

    Clostridioides difficile infection according the CDC definitions

  2. 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)

Other outcomes

  1. 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

  2. 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.

  3. 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

  4. 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Paige Druce, MSc(Epi)

CONTACT

[email protected]

9903 0016 ext. +61 3

Sarah Astbury

CONTACT

[email protected]

9076 6071 ext. +61 3

Sponsors and collaborators

Lead sponsor

Monash University

Other

Collaborators

  • ANZCA CTN

Registry information

Official study title

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

Acronym: CALIPSO

Important dates

Study start
2023
Primary completion
2027
Study completion
2028
First posted
Jul 7, 2022
Registry last updated
Mar 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.