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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.

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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.

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Eligibility criteria

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

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
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    Eligibility

    Age eligible for study : 18 and older

    Healthy volunteers accepted : No

    Gender eligible for study: All

    Things to know

    Study dates

    Study start: 2023-02-07

    Primary completion: 2027-01-01

    Study completion finish: 2027-06-01

    study type

    Study type

    PREVENTION

    phase

    Phase

      PHASE4

    trial

    Trial ID

    NCT05447559

    Intervention or treatment

    DRUG: Cefazolin

    DRUG: Water for injection

    Conditions

    • Surgical Site Infection

    Find a site

    Closest Location:

    Westmead Hospital

    Research sites nearby

    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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    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
    • Intravenous administration of 10mL sterile 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
    • Intravenous administration of 2 g cefazolin
    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
    • Intravenous administration of 2 g cefazolin

    What is the study measuring?

    Primary outcome

    Primary Outcome MeasurePrimary Outcome DescriptionPrimary Outcome Time Frame
    Incidence of surgical site infectionSurgical site infection according to CDC / NHSN definition90 days from index surgery

    Secondary outcome

    Secondary Outcome MeasureSecondary Outcome DescriptionSecondary Outcome Time 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

    Frequently Asked Questions

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    References

    Clinical Trials Gov: Duration of Cardiac Antimicrobial Prophylaxis Outcomes Study

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