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Duration of Cardiac Antimicrobial Prophylaxis Outcomes Study

ConditionSurgical Site Infection
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorMonash University

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Cefazolin

    Drug

    Intravenous administration of 2 g cefazolin

  • Water for injection

    Drug

    Intravenous administration of 10mL sterile water for injection

Treatment groups

9,180 Participants
are divided into 3 treatment groups
Group A: Intraoperative only Surgical Antimicrobial Prophylaxis ArmPlacebo comparator 1 intervention
Group B: Intraoperative and 24-hours Postoperative Surgical Antimicrobial Prophylaxis ArmOther 2 interventions
Group C: Intraoperative and 48-hours Postoperative Surgical Antimicrobial Prophylaxis ArmActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of surgical site infection

Surgical site infection according to CDC / NHSN definition

Time frame
90 days from index surgery

Secondary outcomes

1

Incidence of Clostridioides difficile infection

Clostridioides difficile infection according the CDC definitions

Time frame
30 days from index surgery
2

Incidence of other health care association infections

Composite of all other HCAIs (pneumonia, blood stream infection and urinary tract infection)

Time frame
From date of randomization until the date of discharge from the acute healthcare facility or date of death from any cause, whichever came first, assessed up to 30 days from index surgery

Other outcomes

1

Incidence of Antimicrobial hypersensitivity reactions

Immediate (\<48 hrs after exposure) or delayed (≥24 hrs after exposure) reaction to study drug

Time frame
From date of randomization until the date of discharge from the acute healthcare facility or date of death from any cause, whichever came first, assessed up to 30 days from index surgery
2

All-cause mortality rate

Death reported up to 180 days from index cardiac surgery due to any cause.

Time frame
180 days from index surgery
3

Incidence of acute kidney injury

AKI will be defined according to the RIFLE criteria

Time frame
From date of randomization until the date of discharge from the acute healthcare facility or date of death from any cause, whichever came first, assessed up to 30 days from index surgery
4

Incidence of surgical site infections due to drug-resistant infections

Surgical site infections due to drug-resistant infections (defined as resistance to cefazolin)

Time frame
90 days from index surgery

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Monash University

Lead sponsor

ANZCA CTN

Collaborator

Source ClinicalTrials.gov
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