RecruitingPhase 4NCT05447559

Duration of Cardiac Antimicrobial Prophylaxis Outcomes Study

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

Sponsor

Monash University

Enrollment

9,180 participants

Start Date

Feb 7, 2023

Study Type

INTERVENTIONAL

Conditions

Surgical Site Infection

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

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing how long antibiotics should be given to prevent infection after open-heart surgery through the chest (median sternotomy). Infections after heart surgery, especially deep chest wound infections, are serious and sometimes life-threatening. The standard prevention approach uses the antibiotic cefazolin, but the ideal duration of treatment is still debated. This study is looking for the shortest effective course to minimize side effects and antibiotic resistance. You may be eligible if: - You are 18 years or older - You are undergoing cardiac surgery through a median sternotomy (chest opening) You may NOT be eligible if: - You have severe kidney problems (GFR below 40 mL/min or requiring dialysis) - You are having surgery for suspected or proven endocarditis or deep chest wound infection - You have a documented allergy to cefazolin - You have had MRSA (drug-resistant staph) colonization or infection in the past 12 months - You are undergoing a heart transplant or receiving a ventricular assist device - You have been previously enrolled in the CALIPSO trial Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCefazolin

Intravenous administration of 2 g cefazolin

DRUGWater 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