Clinical trial NCT05447559: Duration of Cardiac Antimicrobial Prophylaxis Outcomes Study
Official title: Multicentre, Adaptive, Double-blind, Three-arm, Placebo-controlled, Noninferiority Trial Examining Antimicrobial Prophylaxis Duration in Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Surgical Site Infection
Keywords: Cardiac surgery
Lead sponsor: Monash University
Sponsor class: OTHER
Collaborators: name: The Australian and New Zealand College of Anaesthetists (ANZCA)
First posted: 2022-07-07
Enrollment: 9180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Adaptive, double-blind, three-arm, placebo-controlled, phase IV, noninferiority trial
Primary purpose: PREVENTION

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

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of surgical site infection
timeFrame: 90 days from index surgery
Secondary outcomes:
measure: Incidence of Clostridioides difficile infection
timeFrame: 30 days from index surgery
measure: Incidence of other health care association infections
timeFrame: 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 outcomes:
measure: Incidence of Antimicrobial hypersensitivity reactions
timeFrame: 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
measure: All-cause mortality rate
timeFrame: 180 days from index surgery
measure: Incidence of acute kidney injury
timeFrame: 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
measure: Incidence of surgical site infections due to drug-resistant infections
timeFrame: 90 days from index surgery
Locations:
city: Sydney
country: Australia
facility: Westmead Hospital
state: New South Wales
city: Sydney
country: Australia
facility: St George Hospital
state: New South Wales
city: Brisbane
country: Australia
facility: The Prince Charles Hospital
state: Queensland
city: Brisbane
country: Australia
facility: Princess Alexandra Hospital
state: Queensland
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital
state: South Australia
city: Adelaide
country: Australia
facility: Flinders Medical Centre
state: South Australia
city: Adelaide
country: Australia
facility: Flinders Private
state: South Australia
city: Hobart
country: Australia
facility: Royal Hobart Hospital
state: Tasmania
city: Melbourne
country: Australia
facility: The Alfred Hospital
state: Victoria
city: Melbourne
country: Australia
facility: The Royal Melbourne Hospital
state: Victoria
city: Melbourne
country: Australia
facility: Austin Health
state: Victoria
city: Melbourne
country: Australia
facility: Epworth HealthCare
state: Victoria
city: Melbourne
country: Australia
facility: Epworth Eastern HealthCare
state: Victoria
city: Melbourne
country: Australia
facility: Cabrini Health
state: Victoria
city: Melbourne
country: Australia
facility: Victorian Heart Hospital
state: Victoria
city: Nedlands
country: Australia
facility: Sir Charles Gairdner
state: Western Australia
city: Perth
country: Australia
facility: St John of God Subiaco Hospital
state: Western Australia
city: Perth
country: Australia
facility: Fiona Stanley Hospital
state: Western Australia
city: Melbourne
country: Australia
facility: St Vincent's Hospital
city: Christchurch
country: New Zealand
facility: Christchurch Hospital
city: Hamilton
country: New Zealand
facility: Waikato Hospital
city: Wellington
country: New Zealand
facility: Wellington Hospital
Study officials:
affiliation: Monash University
name: Trisha Peel, MBBS GradCertRes FRACP PhD
role: PRINCIPAL_INVESTIGATOR
References: