Duration of Cardiac Antimicrobial Prophylaxis Outcomes Study

Surgical Site Infection Clinical Trial

— CALIPSO  

Official title:

Multicentre, Adaptive, Double-blind, Three-arm, Placebo-controlled, Noninferiority Trial Examining Antimicrobial Prophylaxis Duration in Cardiac Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05447559
• Other study ID #: 228/22
• Status: Recruiting
• Phase: Phase 4
• Start date: February 7, 2023
• Est. completion date: June 2027

Study information

• Verified date: July 2023
• Source: Monash University
• Contact: Paige Druce, MSc(Epi)
• Phone: 9903 0016
• Email: paige.druce[@]monash.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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 information / eligibility

• Status: Recruiting
• Enrollment: 9180
• Est. completion date: June 2027
• Est. primary completion date: January 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Surgical Site Infection
• Surgical Wound Infection

Intervention

Drug:
• Cefazolin
Intravenous administration of 2 g cefazolin
• Water for injection
Intravenous administration of 10mL sterile water for injection

Locations

Country	Name	City	State
Australia	Flinders Medical Centre	Adelaide	South Australia
Australia	Flinders Private	Adelaide	South Australia
Australia	Royal Adelaide Hospital	Adelaide	South Australia
Australia	Princess Alexandra Hospital	Brisbane	Queensland
Australia	The Prince Charles Hospital	Brisbane	Queensland
Australia	Royal Hobart Hospital	Hobart	Tasmania
Australia	Austin Health	Melbourne	Victoria
Australia	Cabrini Health	Melbourne	Victoria
Australia	Epworth Eastern HealthCare	Melbourne	Victoria
Australia	Epworth HealthCare	Melbourne	Victoria
Australia	Melbourne Private Hospital	Melbourne	Victoria
Australia	Monash Health	Melbourne	Victoria
Australia	The Alfred Hospital	Melbourne	Victoria
Australia	The Royal Melbourne Hospital	Melbourne	Victoria
Australia	Victorian Heart Hospital	Melbourne	Victoria
Australia	St John of God Subiaco Hospital	Perth	Western Australia
Australia	St George Hospital	Sydney	New South Wales
Australia	Westmead Hospital	Sydney	New South Wales
New Zealand	Waikato Hospital	Hamilton

Sponsors (2)

Lead Sponsor	Collaborator
Monash University	The Alfred

Countries where clinical trial is conducted

Australia,  New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Incidence of Antimicrobial hypersensitivity reactions	Immediate (<48 hrs after exposure) or delayed (=24 hrs after exposure) reaction to study drug	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
Other	All-cause mortality rate	Death reported up to 180 days from index cardiac surgery due to any cause.	180 days from index surgery
Other	Incidence of acute kidney injury	AKI will be defined according to the RIFLE criteria	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
Other	Incidence of surgical site infections due to drug-resistant infections	Surgical site infections due to drug-resistant infections (defined as resistance to cefazolin)	90 days from index surgery
Primary	Incidence of surgical site infection	Surgical site infection according to CDC / NHSN definition	90 days from index surgery
Secondary	Incidence of Clostridioides difficile infection	Clostridioides difficile infection according the CDC definitions	30 days from index surgery
Secondary	Incidence of other health care association infections	Composite 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