Comparing durations of antibiotic use after cardiac surgery
Multicentre, Adaptive, Double-blind, Three-arm, Placebo-controlled, Noninferiority Trial Examining Antimicrobial Prophylaxis Duration in Cardiac Surgery
This study is testing how long to give antibiotics after heart surgery to see which duration best prevents infections.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 9180 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Monash University Academic / other |
| Locations | 27 sites (Dallas, Texas and 26 other locations) |
| Trial ID | NCT05447559 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adult patients undergoing cardiac surgery involving a median sternotomy.
Not a fit: Patients under 18, those with severe comorbidities, or specific infections or allergies may not benefit from this study.
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 performed: Previous studies have shown varying success with antibiotic prophylaxis durations, making this approach both relevant and necessary for further exploration.
Eligibility criteria
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 this trial is running
Dallas, Texas and 26 other locations
- UT Southwestern Medical Centre — Dallas, Texas, United States (Not_yet_recruiting)
- Westmead Hospital — Sydney, New South Wales, Australia (Recruiting)
- St George Hospital — Sydney, New South Wales, Australia (Active_not_recruiting)
- The Prince Charles Hospital — Brisbane, Queensland, Australia (Recruiting)
- Princess Alexandra Hospital — Brisbane, Queensland, Australia (Recruiting)
- St Andrew's War Memorial Hospital — Brisbane, Queensland, Australia (Active_not_recruiting)
- Royal Adelaide Hospital — Adelaide, South Australia, Australia (Recruiting)
- Flinders Medical Centre — Adelaide, South Australia, Australia (Recruiting)
- Flinders Private — Adelaide, South Australia, Australia (Recruiting)
- 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)
- Sir Charles Gairdner — Nedlands, Western Australia, Australia (Not_yet_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)
- 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)
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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.