Duration of Cardiac Antimicrobial Prophylaxis Outcomes Study

Phase 4RecruitingNCT05447559

Monash University9,180 enrolled

Overview

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

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

9,180

Conditions

Surgical Site Infection

Interventions

CefazolinDRUG

Intravenous administration of 2 g cefazolin

Water for injectionDRUG

Intravenous administration of 10mL sterile water for injection

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (27)

Outcomes

Primary Outcomes

Incidence of surgical site infection

Surgical site infection according to CDC / NHSN definition

Time frame: 90 days from index surgery

Secondary Outcomes

Incidence of Clostridioides difficile infection

Clostridioides difficile infection according the CDC definitions

Time frame: 30 days from index surgery

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

Central Contacts

Paige Druce, MSc(Epi)

CONTACT

9903 0016 paige.druce@monash.edu

Sarah Astbury

CONTACT

9076 6071 sarah.astbury@monash.edu

Data from ClinicalTrials.gov

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