NCT05447559 · Monash University
Duration of Cardiac Antimicrobial Prophylaxis Outcomes Study
(CALIPSO)
What this study is about
This multicentre, adaptive, pragmatic, where neither patients nor doctors know which treatment is given, three-treatment group$1, compared against an inactive treatment, 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 (treatment group$1 A), to 24 hours (treatment group$1 B) and, to 48 hours (treatment group$1 C) of IV cefazolin and placebo postoperative surgical antimicrobial prophylaxis in patients undergoing cardiac surgery
View original scientific description
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
Interventions
DRUG
Cefazolin
Intravenous administration of 2 g cefazolin
DRUG
Water for injection
Intravenous administration of 10mL sterile water for injection
Primary outcome measures
Incidence of surgical site infection
Time frame: 90 days from index surgery
Surgical site infection according to CDC / NHSN definition
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Dallas, Texas
Collaborators
ANZCA CTN
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 25, 2026 · Source of record for eligibility and locations