Duration of Cardiac Antimicrobial Prophylaxis Outcomes Study
- Conditions
- Surgical Site Infection
- Interventions
- 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
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 9180
- Adult patients undergoing cardiac surgery involving a median sternotomy
- 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
Scroll for more (12 remaining)Sir Charles Gairdner🇦🇺Nedlands, Western Australia, AustraliaPeri MickleContact+61 (08) 6457 7220peri.mickle@health.wa.gov.auJames PreussContact