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Duration of Cardiac Antimicrobial Prophylaxis Outcomes Study (CALIPSO)

Primary Purpose

Surgical Site Infection

Status
Recruiting
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Cefazolin
Water for injection
Sponsored by
Monash University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Surgical Site Infection focused on measuring Cardiac surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Westmead HospitalRecruiting
  • St George Hospital
  • The Prince Charles HospitalRecruiting
  • Princess Alexandra Hospital
  • Royal Adelaide Hospital
  • Flinders Medical Centre
  • Flinders Private
  • Royal Hobart Hospital
  • The Alfred HospitalRecruiting
  • Melbourne Private Hospital
  • The Royal Melbourne Hospital
  • Austin Health
  • Epworth HealthCare
  • Epworth Eastern HealthCare
  • Cabrini Health
  • Monash HealthRecruiting
  • Victorian Heart HospitalRecruiting
  • St John of God Subiaco HospitalRecruiting
  • Waikato Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Other

Active Comparator

Arm Label

Intraoperative only Surgical Antimicrobial Prophylaxis Arm

Intraoperative and 24-hours Postoperative Surgical Antimicrobial Prophylaxis Arm

Intraoperative and 48-hours Postoperative Surgical Antimicrobial Prophylaxis Arm

Arm Description

Placebo administered every 8-hours following the preoperative dose (time=0) for a total of five postoperative doses

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)

Cefazolin (2g) administered every 8-hours following the preoperative dose (time=0) for a total of five postoperative doses

Outcomes

Primary Outcome Measures

Incidence of surgical site infection
Surgical site infection according to CDC / NHSN definition

Secondary Outcome Measures

Incidence of Clostridioides difficile infection
Clostridioides difficile infection according the CDC definitions
Incidence of other health care association infections
Composite of all other HCAIs (pneumonia, blood stream infection and urinary tract infection)

Full Information

First Posted
June 27, 2022
Last Updated
July 13, 2023
Sponsor
Monash University
Collaborators
The Alfred
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1. Study Identification

Unique Protocol Identification Number
NCT05447559
Brief Title
Duration of Cardiac Antimicrobial Prophylaxis Outcomes Study
Acronym
CALIPSO
Official Title
Multicentre, Adaptive, Double-blind, Three-arm, Placebo-controlled, Noninferiority Trial Examining Antimicrobial Prophylaxis Duration in Cardiac Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 7, 2023 (Actual)
Primary Completion Date
January 2027 (Anticipated)
Study Completion Date
June 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Monash University
Collaborators
The Alfred

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgical Site Infection
Keywords
Cardiac surgery

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Adaptive, double-blind, three-arm, placebo-controlled, phase IV, noninferiority trial
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Participants, treating clinicians, all members of the research team including the study statistician will be blinded to treatment arm allocation. Active treatment will consist of 2-grams cefazolin powder for injection. Placebo will consist of an identical empty vial. The commercial labels will be removed and a sheath placed over the vial. Amber-tinted syringes will be provided for drawing up and administration of cefazolin/placebo to mask study arm. The vial containing cefazolin or placebo will be reconstituted in a minimum of 10 mL of sterile water for injections and administered in keeping with product information for cefazolin and / or local guidelines.
Allocation
Randomized
Enrollment
9180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intraoperative only Surgical Antimicrobial Prophylaxis Arm
Arm Type
Placebo Comparator
Arm Description
Placebo administered every 8-hours following the preoperative dose (time=0) for a total of five postoperative doses
Arm Title
Intraoperative and 24-hours Postoperative Surgical Antimicrobial Prophylaxis Arm
Arm Type
Other
Arm Description
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)
Arm Title
Intraoperative and 48-hours Postoperative Surgical Antimicrobial Prophylaxis Arm
Arm Type
Active Comparator
Arm Description
Cefazolin (2g) administered every 8-hours following the preoperative dose (time=0) for a total of five postoperative doses
Intervention Type
Drug
Intervention Name(s)
Cefazolin
Intervention Description
Intravenous administration of 2 g cefazolin
Intervention Type
Drug
Intervention Name(s)
Water for injection
Intervention Description
Intravenous administration of 10mL sterile water for injection
Primary Outcome Measure Information:
Title
Incidence of surgical site infection
Description
Surgical site infection according to CDC / NHSN definition
Time Frame
90 days from index surgery
Secondary Outcome Measure Information:
Title
Incidence of Clostridioides difficile infection
Description
Clostridioides difficile infection according the CDC definitions
Time Frame
30 days from index surgery
Title
Incidence of other health care association infections
Description
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
Other Pre-specified Outcome Measures:
Title
Incidence of Antimicrobial hypersensitivity reactions
Description
Immediate (<48 hrs after exposure) or delayed (≥24 hrs after exposure) reaction to study drug
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
Title
All-cause mortality rate
Description
Death reported up to 180 days from index cardiac surgery due to any cause.
Time Frame
180 days from index surgery
Title
Incidence of acute kidney injury
Description
AKI will be defined according to the RIFLE criteria
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
Title
Incidence of surgical site infections due to drug-resistant infections
Description
Surgical site infections due to drug-resistant infections (defined as resistance to cefazolin)
Time Frame
90 days from index surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Paige Druce, MSc(Epi)
Phone
9903 0016
Ext
+61 3
Email
paige.druce@monash.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Sarah Astbury
Phone
9076 6071
Ext
+61 3
Email
sarah.astbury@monash.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Trisha Peel, MBBS GradCertRes FRACP PhD
Organizational Affiliation
Monash University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Westmead Hospital
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Louise Cope
First Name & Middle Initial & Last Name & Degree
Alison Williams
Facility Name
St George Hospital
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2217
Country
Australia
Individual Site Status
Active, not recruiting
Facility Name
The Prince Charles Hospital
City
Brisbane
State/Province
Queensland
ZIP/Postal Code
4032
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Donalee O'Brien
Phone
+6131394130
Email
Donalee.Obrien@health.qld.gov.au
First Name & Middle Initial & Last Name & Degree
Mbakise Matebele
Facility Name
Princess Alexandra Hospital
City
Brisbane
State/Province
Queensland
ZIP/Postal Code
4102
Country
Australia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Allison Kearney
Email
allison.kearney@healh.qld.gov.au
First Name & Middle Initial & Last Name & Degree
David Highton
Facility Name
Royal Adelaide Hospital
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kate Drummond
Email
kate.drummond@sa.gov.au
First Name & Middle Initial & Last Name & Degree
Kate Drummond
Facility Name
Flinders Medical Centre
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5042
Country
Australia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rhys Hamson
Email
Rhys.Hamson@sa.gov.au
First Name & Middle Initial & Last Name & Degree
Rob Baker
Facility Name
Flinders Private
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5042
Country
Australia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rhys Hamson
Email
Rhys.Hamson@sa.gov.au
First Name & Middle Initial & Last Name & Degree
Rob Baker
Facility Name
Royal Hobart Hospital
City
Hobart
State/Province
Tasmania
ZIP/Postal Code
7000
Country
Australia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Robyn Seale
Email
researchanaesdept@ths.tas.gov.au
First Name & Middle Initial & Last Name & Degree
Michael Challis
Facility Name
The Alfred Hospital
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sarah Astbury
Phone
+61399039261
Email
sarah.astbury@monash.edu
First Name & Middle Initial & Last Name & Degree
Sarah Robertshaw
Phone
+61390763709
Email
s.robertshaw@alfred.org.au
First Name & Middle Initial & Last Name & Degree
Silvana Marasco
Facility Name
Melbourne Private Hospital
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3050
Country
Australia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zelda Williams
Email
research@heartweb.com
First Name & Middle Initial & Last Name & Degree
Alistair Royse
Facility Name
The Royal Melbourne Hospital
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3050
Country
Australia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zelda Williams
Email
research@heartweb.com
First Name & Middle Initial & Last Name & Degree
Alistair Royse
Facility Name
Austin Health
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3084
Country
Australia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gayle Claxton
Email
Gayle.CLAXTON@austin.org.au
First Name & Middle Initial & Last Name & Degree
Lachlan Miles
Facility Name
Epworth HealthCare
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3121
Country
Australia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicole Tan
Email
niki.tan@anaestheticservices.com.au
First Name & Middle Initial & Last Name & Degree
Nicole Tan
Facility Name
Epworth Eastern HealthCare
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3128
Country
Australia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicole Tan
Email
niki.tan@anaestheticservices.com.au
First Name & Middle Initial & Last Name & Degree
Nicole Tan
Facility Name
Cabrini Health
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3144
Country
Australia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lisa Dougherty
Email
icuresearch@cabrini.com.au
First Name & Middle Initial & Last Name & Degree
Vineet Sarode
Facility Name
Monash Health
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3168
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amanda Hulley
Phone
+61385722652
Email
Amanda.Hulley@monashhealth.org
First Name & Middle Initial & Last Name & Degree
Julian Smith
Facility Name
Victorian Heart Hospital
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3168
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amanda Hulley
Phone
+61385722652
Email
Amanda.Hulley@monashhealth.org
First Name & Middle Initial & Last Name & Degree
Julian Smith
Facility Name
St John of God Subiaco Hospital
City
Perth
State/Province
Western Australia
ZIP/Postal Code
6008
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yvonne Buller
Email
yvonne.buller@sjog.org.au
First Name & Middle Initial & Last Name & Degree
Tomas Corcoran
Facility Name
Waikato Hospital
City
Hamilton
ZIP/Postal Code
3204
Country
New Zealand
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jonathon Termaat
Email
Jonathan.Termaat@waikatodhb.health.nz
First Name & Middle Initial & Last Name & Degree
Kelly Byrne

12. IPD Sharing Statement

Plan to Share IPD
No

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