Duration of Cardiac Antimicrobial Prophylaxis Outcomes Study

RECRUITING

NCT05447559

PHASE4

Sponsor: Monash University

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

Official title: Multicentre, Adaptive, Double-blind, Three-arm, Placebo-controlled, Noninferiority Trial Examining Antimicrobial Prophylaxis Duration in Cardiac Surgery

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

9180

Start Date

2023-02-07

Completion Date

2028-06

Last Updated

2026-03-25

Healthy Volunteers

No

Conditions

Surgical Site Infection

Interventions

DRUG

Cefazolin

Intravenous administration of 2 g cefazolin

DRUG

Water for injection

Intravenous administration of 10mL sterile water for injection

Locations (27)

UT Southwestern Medical Centre

Dallas, Texas, United States

Westmead Hospital

Sydney, New South Wales, Australia

St George Hospital

Sydney, New South Wales, Australia

The Prince Charles Hospital

Brisbane, Queensland, Australia

Princess Alexandra Hospital

Brisbane, Queensland, Australia

St Andrew's War Memorial Hospital

Brisbane, Queensland, Australia

Royal Adelaide Hospital

Adelaide, South Australia, Australia

Flinders Medical Centre

Adelaide, South Australia, Australia

Flinders Private

Adelaide, South Australia, Australia

Royal Hobart Hospital

Hobart, Tasmania, Australia

The Alfred Hospital