Duration of Cardiac Antimicrobial Prophylaxis Outcomes Study

Phase 4

Recruiting

• Conditions: Surgical Site Infection
• Interventions: Drug: Cefazolin; Drug: Water for injection

• Registration Number: NCT05447559
• Lead Sponsor: Monash University

Brief 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

Detailed Description

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 Timeline

• Study First Submitted: 2022-06-27
• Study First Submitted QC: 2022-07-05
• Study First Posted: 2022-07-07
• Study Start: 2023-02-07
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-20
• Last Update Posted: 2024-11-22
• Primary Completion: 2027-01
• Study Completion: 2027-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 9180

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intraoperative and 24-hours Postoperative Surgical Antimicrobial Prophylaxis Arm	Water for injection	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)
Intraoperative and 24-hours Postoperative Surgical Antimicrobial Prophylaxis Arm	Cefazolin	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)
Intraoperative and 48-hours Postoperative Surgical Antimicrobial Prophylaxis Arm	Cefazolin	Cefazolin (2g) administered every 8-hours following the preoperative dose (time=0) for a total of five postoperative doses
Intraoperative only Surgical Antimicrobial Prophylaxis Arm	Water for injection	Placebo administered every 8-hours following the preoperative dose (time=0) for a total of five postoperative doses

Primary Outcome Measures

Name	Time	Method
Incidence of surgical site infection	90 days from index surgery	Surgical site infection according to CDC / NHSN definition

Secondary Outcome Measures

Name	Time	Method
Incidence of other health care association infections	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	Composite of all other HCAIs (pneumonia, blood stream infection and urinary tract infection)
Incidence of Clostridioides difficile infection	30 days from index surgery	Clostridioides difficile infection according the CDC definitions

Trial Locations

Locations (22)

Sir Charles Gairdner; 🇦🇺 Nedlands, Western Australia, Australia

Fiona Stanley Hospital; 🇦🇺 Perth, Western Australia, Australia

St Vincent's Hospital; 🇦🇺 Melbourne, Australia

Christchurch Hospital; 🇳🇿 Christchurch, New Zealand

Wellington Hospital; 🇳🇿 Wellington, New Zealand

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

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; 🇦🇺 Melbourne, Victoria, Australia

The Royal Melbourne Hospital; 🇦🇺 Melbourne, Victoria, Australia

Austin Health; 🇦🇺 Melbourne, Victoria, Australia

Epworth HealthCare; 🇦🇺 Melbourne, Victoria, Australia

Epworth Eastern HealthCare; 🇦🇺 Melbourne, Victoria, Australia

Cabrini Health; 🇦🇺 Melbourne, Victoria, Australia

Victorian Heart Hospital; 🇦🇺 Melbourne, Victoria, Australia

St John of God Subiaco Hospital; 🇦🇺 Perth, Western Australia, Australia

Waikato Hospital; 🇳🇿 Hamilton, New Zealand