Recruiting

CefazolinDuration of Cardiac Antimicrobial Prophylaxis Outcomes Study

Sponsor:

Monash University

Code:

NCT05447559

Conditions

Surgical Site Infection

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Cefazolin

Water for injection

Study Details

Brief 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

Conditions

Surgical Site Infection

Study ID

NCT05447559

Start date

Feb 7, 2023

Status verified date

Mar, 2026

Completion date

Jun, 2028

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

9180 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

placebo comparator: Intraoperative only Surgical Antimicrobial Prophylaxis Arm

Placebo administered every 8-hours following the preoperative dose (time=0) for a total of five postoperative doses

other: Intraoperative and 24-hours Postoperative Surgical Antimicrobial Prophylaxis Arm

Cefazolin (2g) administered 8-hourly following the preoperative dose (time=0) for two doses then placebo 8-hourly for three doses (total of 5 postoperative doses of cefazolin/placebo)

active comparator: Intraoperative and 48-hours Postoperative Surgical Antimicrobial Prophylaxis Arm

Cefazolin (2g) administered every 8-hours following the preoperative dose (time=0) for a total of five postoperative doses

Interventions

Cefazolin

Intravenous administration of 2 g cefazolin

Water for injection

Intravenous administration of 10mL sterile water for injection

Primary outcome measure

Incidence of surgical site infection [ Time Frame: 90 days from index surgery ]

Central Contacts and Locations

Central contacts

Paige Druce, MSc(Epi)

9903 0016 paige.druce@monash.edu

Sarah Astbury

9076 6071 sarah.astbury@monash.edu

Locations

Halifax Infirmary

Recruiting

Halifax, Nova Scotia, Canada

More Information

Sponsor

Monash University

Last update posted

Mar 25, 2026

Last verified

Mar, 2026

Keywords

Cardiac surgery

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Monash University on 2026-03-25.