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Duration of Cardiac Antimicrobial Prophylaxis Outcomes Study

PHASE4RECRUITING

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.

Study details:

This trial will evaluate the clinical effectiveness, health-economic outcomes and microbiological impact of intraoperative (only) compared with intraoperative plus postoperative prophylaxis durations in patients undergoing cardiac surgery. CALIPSO, a multicentre, adaptive, double-blind, three-arm, placebo-controlled, phase IV, noninferiority trial will examine the incidence proportion of SSI following cardiac surgery. Our three-intervention trial will compare:.

Arm A Administration of prophylaxis in intraoperative period only Arm B Administration of prophylaxis in intraoperative plus for 24 hours postoperatively Arm C Administration of prophylaxis in intraoperative plus for 48 hours postoperatively.

Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

Inclusion criteria

  1. Adult patients undergoing cardiac surgery involving a median sternotomy

Exclusion criteria

  1. Age <18 years
  2. American Society of Anesthesiology (ASA) 5
  3. Subjects with GFR <40mL/min/1.73m2 or those requiring continuous renal replacement therapy, haemodialysis or peritoneal dialysis
  4. Surgery for suspected or proven endocarditis or deep sternal wound infection
  5. Documented cefazolin hypersensitivity
  6. Documented methicillin resistant Staphylococcus aureus (MRSA) colonisation or infection in the 12-months prior to index surgery
  7. Cardiac transplantation
  8. Procedures involving insertion ventricular assist device or mechanical circulatory support device
  9. Procedures not involving a median sternotomy
  10. Patients previously enrolled and randomised to the CALIPSO trial

Eligibility

Age eligible for study : NA

Healthy volunteers accepted : No

Gender eligible for study: ALL

Things to know

Study dates

Study start:

Primary completion:

Study completion finish:

study type

Study type

PREVENTION

phase

Phase

    PHASE4

trial

Study ID

NCT05447559

Intervention or treatment

DRUG: Cefazolin

DRUG: Water for injection

Conditions

  • Surgical Site Infection

  • Condition: Surgical Site Infection

  • DRUG: Cefazolin and other drugs

  • Sydney, New South Wales, Australia and more

  • Sponsor: Monash University

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Are you running this trial?

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Research sites nearby

Closest Location:

Westmead Hospital

Select from list below to view details:

  • 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

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Who is running the clinical trial?

MU

Monash University

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/ArmIntervention/Treatment
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
Drug: Water for injection
    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)
    Drug: Cefazolin, Drug: Water for injection
      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
      Drug: Cefazolin

        What is the study measuring?

        Primary Outcome

        MeasureDescriptionTime Frame
        Incidence of surgical site infectionSurgical site infection according to CDC / NHSN definition90 days from index surgery

        Secondary Outcome

        MeasureDescriptionTime Frame
        Incidence of Clostridioides difficile infectionClostridioides difficile infection according the CDC definitions30 days from index surgery
        Incidence of other health care association infectionsComposite of all other HCAIs (pneumonia, blood stream infection and urinary tract infection)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
        Are you running this trial?If you're a clinic or sponsor, you can claim this study.
        Claim this trial

        References

        Clinical Trials Gov: Duration of Cardiac Antimicrobial Prophylaxis Outcomes Study

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