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Clinical Trials in Australia / NCT05447559
Recruiting Phase 4

Duration of Cardiac Antimicrobial Prophylaxis Outcomes Study

NCT05447559 · tracked via the Priya Life Science Australia tracker
Sponsor
Monash University
Phase
Phase 4
Started
2023-02-07
Last updated
2026-03-25

Condition(s) studied

Surgical Site Infection

Investigational drug(s) / intervention(s)

Cefazolin →Water for injection

Cefazolin: Intravenous administration of 2 g cefazolin

Water for injection: Intravenous administration of 10mL sterile water for injection

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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (27)

FacilityCityRegionStatus
UT Southwestern Medical Centre Dallas Texas Not Yet Recruiting
Westmead Hospital Sydney New South Wales Recruiting
St George Hospital Sydney New South Wales Active Not Recruiting
The Prince Charles Hospital Brisbane Queensland Recruiting
Princess Alexandra Hospital Brisbane Queensland Recruiting
St Andrew's War Memorial Hospital Brisbane Queensland Active Not Recruiting
Royal Adelaide Hospital Adelaide South Australia Recruiting
Flinders Medical Centre Adelaide South Australia Recruiting
Flinders Private Adelaide South Australia Recruiting
Royal Hobart Hospital Hobart Tasmania Recruiting
The Alfred Hospital Melbourne Victoria Recruiting
The Royal Melbourne Hospital Melbourne Victoria Recruiting
Austin Health Melbourne Victoria Recruiting
Epworth HealthCare Melbourne Victoria Recruiting
Cabrini Health Melbourne Victoria Recruiting
Victorian Heart Hospital Melbourne Victoria Recruiting
Sir Charles Gairdner Nedlands Western Australia Not Yet Recruiting
St John of God Subiaco Hospital Perth Western Australia Recruiting
Fiona Stanley Hospital Perth Western Australia Recruiting
St Vincent's Hospital Melbourne Australia Recruiting
Halifax Infirmary Halifax Nova Scotia Recruiting
IJN Kuala Lumpur Malaysia Recruiting
UMMC Kuala Lumpur Malaysia Not Yet Recruiting
Christchurch Hospital Christchurch New Zealand Recruiting
Waikato Hospital Hamilton New Zealand Recruiting
Wakefield Hospital Wellington New Zealand Not Yet Recruiting
Wellington Hospital Wellington New Zealand Recruiting

More Monash University trials in Australia

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Validation of the Lupus Low Disease Activity State (LLDAS) in the Asia Pacific Region Recruiting
Role of Antibiotic Therapy or Immunoglobulin On iNfections in hAematoLogy Platform Trial (RATIONAL-PT) Recruiting

Other trials for the same condition

Tranexamic Acid to Reduce Delirium After Gastrointestinal Surgery: the TRIGS-D Trial Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05447559 on ClinicalTrials.gov ↗ ← All trials in Australia