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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05447559




Registration number
NCT05447559
Ethics application status
Date submitted
27/06/2022
Date registered
7/07/2022
Date last updated
14/07/2023

Titles & IDs
Public title
Duration of Cardiac Antimicrobial Prophylaxis Outcomes Study
Scientific title
Multicentre, Adaptive, Double-blind, Three-arm, Placebo-controlled, Noninferiority Trial Examining Antimicrobial Prophylaxis Duration in Cardiac Surgery
Secondary ID [1] 0 0
228/22
Universal Trial Number (UTN)
Trial acronym
CALIPSO
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Surgical Site Infection 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Surgery 0 0 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Cefazolin
Treatment: Drugs - Water for injection

Placebo Comparator: Intraoperative only Surgical Antimicrobial Prophylaxis Arm - Placebo administered every 8-hours following the preoperative dose (time=0) for a total of five postoperative doses

Other: Intraoperative and 24-hours Postoperative Surgical Antimicrobial Prophylaxis Arm - 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)

Active Comparator: Intraoperative and 48-hours Postoperative Surgical Antimicrobial Prophylaxis Arm - Cefazolin (2g) administered every 8-hours following the preoperative dose (time=0) for a total of five postoperative doses


Treatment: Drugs: Cefazolin
Intravenous administration of 2 g cefazolin

Treatment: Drugs: Water for injection
Intravenous administration of 10mL sterile water for injection
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of surgical site infection
Timepoint [1] 0 0
90 days from index surgery
Secondary outcome [1] 0 0
Incidence of Clostridioides difficile infection
Timepoint [1] 0 0
30 days from index surgery
Secondary outcome [2] 0 0
Incidence of other health care association infections
Timepoint [2] 0 0
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

Eligibility
Key inclusion criteria
- Adult patients undergoing cardiac surgery involving a median sternotomy
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
7/02/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/06/2027
Actual
Sample size
Target
9180
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,TAS,VIC,WA
Recruitment hospital [1] 0 0
Westmead Hospital - Sydney
Recruitment hospital [2] 0 0
St George Hospital - Sydney
Recruitment hospital [3] 0 0
The Prince Charles Hospital - Brisbane
Recruitment hospital [4] 0 0
Princess Alexandra Hospital - Brisbane
Recruitment hospital [5] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [6] 0 0
Flinders Medical Centre - Adelaide
Recruitment hospital [7] 0 0
Flinders Private - Adelaide
Recruitment hospital [8] 0 0
Royal Hobart Hospital - Hobart
Recruitment hospital [9] 0 0
The Alfred Hospital - Melbourne
Recruitment hospital [10] 0 0
Melbourne Private Hospital - Melbourne
Recruitment hospital [11] 0 0
The Royal Melbourne Hospital - Melbourne
Recruitment hospital [12] 0 0
Austin Health - Melbourne
Recruitment hospital [13] 0 0
Epworth HealthCare - Melbourne
Recruitment hospital [14] 0 0
Epworth Eastern HealthCare - Melbourne
Recruitment hospital [15] 0 0
Cabrini Health - Melbourne
Recruitment hospital [16] 0 0
Monash Health - Melbourne
Recruitment hospital [17] 0 0
Victorian Heart Hospital - Melbourne
Recruitment hospital [18] 0 0
St John of God Subiaco Hospital - Perth
Recruitment postcode(s) [1] 0 0
2145 - Sydney
Recruitment postcode(s) [2] 0 0
2217 - Sydney
Recruitment postcode(s) [3] 0 0
4032 - Brisbane
Recruitment postcode(s) [4] 0 0
4102 - Brisbane
Recruitment postcode(s) [5] 0 0
5000 - Adelaide
Recruitment postcode(s) [6] 0 0
5042 - Adelaide
Recruitment postcode(s) [7] 0 0
7000 - Hobart
Recruitment postcode(s) [8] 0 0
3004 - Melbourne
Recruitment postcode(s) [9] 0 0
3050 - Melbourne
Recruitment postcode(s) [10] 0 0
3084 - Melbourne
Recruitment postcode(s) [11] 0 0
3121 - Melbourne
Recruitment postcode(s) [12] 0 0
3128 - Melbourne
Recruitment postcode(s) [13] 0 0
3144 - Melbourne
Recruitment postcode(s) [14] 0 0
3168 - Melbourne
Recruitment postcode(s) [15] 0 0
6008 - Perth
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Hamilton

Funding & Sponsors
Primary sponsor type
Other
Name
Monash University
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
The Alfred
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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
Trial website
https://clinicaltrials.gov/ct2/show/NCT05447559
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Trisha Peel, MBBS GradCertRes FRACP PhD
Address 0 0
Monash University
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Paige Druce, MSc(Epi)
Address 0 0
Country 0 0
Phone 0 0
9903 0016
Fax 0 0
Email 0 0
paige.druce@monash.edu
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05447559