Duration of Cardiac Antimicrobial Prophylaxis Outcomes Study (NCT05447559) | Clinical Trial Compass
RecruitingPhase 4
Duration of Cardiac Antimicrobial Prophylaxis Outcomes Study
United States, Australia, Canada9,180 participantsStarted 2023-02-07
Plain-language 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
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.