RecruitingPhase 4

Duration of Cardiac Antimicrobial Prophylaxis Outcomes Study

United States, Australia9,180 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 range18 Years

SexALL

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

What they're measuring

Incidence of surgical site infection

Timeframe: 90 days from index surgery

Trial details

NCT IDNCT05447559

SponsorMonash University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-12

Contact for this trial

Paige Druce, MSc(Epi)

9903 0016 paige.druce@monash.edu

View on ClinicalTrials.gov More Surgical Site Infection trials