Surgical Site InfectionPhase 4CALIPSONCT05447559
Duration of Cardiac Antimicrobial Prophylaxis Outcomes Study
A Phase 4 study testing Cefazolin and Water for injection in people with Surgical Site Infection, run by Monash University at 27 sites in 5 countries.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgical Site Infection
- What is being tested?
- Cefazolin and Water for injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 9,180 participants
- Where
- 27 sitesin 5 countries
- Study dates
- 7 Feb 2023to Jun 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients undergoing cardiac surgery involving a median sternotomy
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
27 sites in 5 countries. Contact the study team or a site near you to ask about taking part.
27 sites in 5 countries
Australia19 sites, 17 recruiting
- Recruiting
Royal Adelaide Hospital
Adelaide, South Australia, 5000
Kate Drummond, kate.drummond@sa.gov.au
Kate Drummond
- Recruiting
Flinders Medical Centre
Adelaide, South Australia, 5042
Rhys Hamson, Rhys.Hamson@sa.gov.au
Rob Baker
- Recruiting
Flinders Private
Adelaide, South Australia, 5042
Rhys Hamson, Rhys.Hamson@sa.gov.au
Rob Baker
- Recruiting
The Prince Charles Hospital
Brisbane, Queensland, 4032
Donalee O'Brien, +6131394130, Donalee.Obrien@health.qld.gov.au
Mbakise Matebele
- Recruiting
Princess Alexandra Hospital
Brisbane, Queensland, 4102
Allison Kearney, allison.kearney@healh.qld.gov.au
David Highton
- Active, not recruiting
St Andrew's War Memorial Hospital
Brisbane, Queensland
- Recruiting
Royal Hobart Hospital
Hobart, Tasmania, 7000
Robyn Seale, researchanaesdept@ths.tas.gov.au
Michael Challis
- Recruiting
The Alfred Hospital
Melbourne, Victoria, 3004
Sarah Astbury, +61399039261, sarah.astbury@monash.edu
Silvana Marasco
- Recruiting
The Royal Melbourne Hospital
Melbourne, Victoria, 3050
Jingfei Wu, research@heartweb.com
Alistair Royse
- Recruiting
Austin Health
Melbourne, Victoria, 3084
Gayle Claxton, Gayle.CLAXTON@austin.org.au
Lachlan Miles
- Recruiting
Epworth HealthCare
Melbourne, Victoria, 3121
Nicole Tan, niki.tan@anaestheticservices.com.au
Nicole Tan
- Recruiting
Cabrini Health
Melbourne, Victoria, 3144
Lisa Dougherty, icuresearch@cabrini.com.au
Vineet Sarode
- Recruiting
Victorian Heart Hospital
Melbourne, Victoria, 3168
Amanda Hulley, +61385722652, Amanda.Hulley@monashhealth.org
Julian Smith
- Recruiting
St Vincent's Hospital
Melbourne
Dima Jayaratne, +61 3 9231 4245, dima.jayaratne@svha.org.au
David Scott
- Not yet recruiting
Sir Charles Gairdner
Nedlands, Western Australia
Peri Mickle, +61 (08) 6457 7220, peri.mickle@health.wa.gov.au
James Preuss
- Recruiting
St John of God Subiaco Hospital
Perth, Western Australia, 6008
Yvonne Buller, yvonne.buller@sjog.org.au
Tomas Corcoran
- Recruiting
Fiona Stanley Hospital
Perth, Western Australia
Prof Ulrich Stock, 0861523636, Ulrich.stock@health.wa.gov.au
Ulrich Stock, Prof
- Recruiting
Westmead Hospital
Sydney, New South Wales, 2145
Louise Cope
Alison Williams
- Active, not recruiting
St George Hospital
Sydney, New South Wales, 2217
New Zealand4 sites, 4 recruiting
- Recruiting
Christchurch Hospital
Christchurch
Jan Mehrtens, +64 (03)3640 640, Jan.Mehrtens@cdhb.health.nz
Jay Ritzema-Carter
- Recruiting
Waikato Hospital
Hamilton, 3204
Jonathon Termaat, Jonathan.Termaat@waikatodhb.health.nz
Kelly Byrne
- Not yet recruiting
Wakefield Hospital
Wellington
Leanlove Navarra
- Recruiting
Wellington Hospital
Wellington
Leanlove Navarra, +64 27 553 1488, Leanlove.Navarra@ccdhb.org.nz
Daniel Frei
Malaysia2 sites, 2 recruiting
- Recruiting
IJN
Kuala Lumpur
Dr Chong Kee Soon
- Not yet recruiting
UMMC
Kuala Lumpur
Prof Sasheela Sri La Sri Ponnampalavanar
United States1 site, 1 recruiting
- Not yet recruiting
UT Southwestern Medical Centre
Dallas, Texas, 75390
Dr Markus Velten
Canada1 site, 1 recruiting
- Recruiting
Halifax Infirmary
Halifax, Nova Scotia
Dr Neville Burke
About this study
Official title: Multicentre, Adaptive, Double-blind, Three-arm, Placebo-controlled, Noninferiority Trial Examining Antimicrobial Prophylaxis Duration in Cardiac Surgery
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
Read the 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
- Conditions
- Surgical Site Infection
- Being tested
- Cefazolin, Water for injection
- Keywords
- Cardiac surgery
- Medical subject headings
- Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CefazolinDrug
Intravenous administration of 2 g cefazolin
Water for injectionDrug
Intravenous administration of 10mL sterile water for injection
| Study group | Role | What they receive |
|---|---|---|
| Intraoperative only Surgical Antimicrobial Prophylaxis Arm | Placebo comparator | Placebo administered every 8-hours following the preoperative dose (time=0) for a total of five postoperative doses Receives: Drug: Water for injection |
| Intraoperative and 24-hours Postoperative Surgical Antimicrobial Prophylaxis Arm | Other | 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) Receives: Drug: Cefazolin; Drug: Water for injection |
| Intraoperative and 48-hours Postoperative Surgical Antimicrobial Prophylaxis Arm | Active comparator | Cefazolin (2g) administered every 8-hours following the preoperative dose (time=0) for a total of five postoperative doses Receives: Drug: Cefazolin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of surgical site infection
Surgical site infection according to CDC / NHSN definition
Measured: 90 days from index surgery
Secondary outcomes (2)
Incidence of Clostridioides difficile infection
Clostridioides difficile infection according the CDC definitions
Measured: 30 days from index surgery
Incidence of other health care association infections
Composite of all other HCAIs (pneumonia, blood stream infection and urinary tract infection)
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2022
- Study start7 Feb 2023
- Primary completionDec 2027 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Surgical Site InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Adaptive, double-blind, three-arm, placebo-controlled, phase IV, noninferiority trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 9,180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Monash University
- Sponsor type
- University, hospital or other
- Collaborators
- ANZCA CTN
- Responsible party
- Principal investigator, Trisha Nicole Peel, Monash University
- Investigators
- Trisha Peel, MBBS GradCertRes FRACP PhD, Principal investigator, Monash University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05447559
- Sponsor's protocol ID
- 228/22
- Acronym
- CALIPSO
- Status last verified
- Mar 2026
- First submitted
- 27 Jun 2022
- Last updated
- 25 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Peel T, McGiffin D, Smith J, Forbes A, Marasco S, Pilcher D, Stewardson AJ, Petrie D, Peleg AY, Wisniewski J, Forster S, Druce P, Roney J, Astbury S, Berkovic D, Mccracken P, Myles PS; CALIPSO Trial Steering Committee. Multicentre, adaptive, double-blind, three-arm, placebo-controlled, non-inferiority trial examining antimicrobial prophylaxis duration in cardiac surgery (CALIPSO): trial protocol. BMJ Open. 2026 Mar 18;16(3):e115209. doi: 10.1136/bmjopen-2025-115209.
PubMed 41857861
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentre, Adaptive, Double-blind, Three-arm, Placebo-controlled, Noninferiority Trial Examining Antimicrobial Prophylaxis Duration in Cardiac Surgery
- ClinicalTrials.gov ID
- NCT05447559
- Acronym / sponsor ID
- CALIPSO / 228/22
- Conditions
- Surgical Site Infection
- Keywords
- Cardiac surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 9,180 participants (estimated)
- Lead sponsor
- Monash UniversityUniversity, hospital or other
- Collaborators
- ANZCA CTN
- Study start
- 7 Feb 2023 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 7 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Adaptive, double-blind, three-arm, placebo-controlled, phase IV, noninferiority trial
| Arm | Type | Receives |
|---|---|---|
| Intraoperative only Surgical Antimicrobial Prophylaxis Arm | Placebo comparator | Drug: Water for injectionPlacebo administered every 8-hours following the preoperative dose (time=0) for a total of five postoperative doses |
| Intraoperative and 24-hours Postoperative Surgical Antimicrobial Prophylaxis Arm | Other | Drug: Cefazolin, Drug: Water for injectionCefazolin (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 | Active comparator | Drug: CefazolinCefazolin (2g) administered every 8-hours following the preoperative dose (time=0) for a total of five postoperative doses |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients undergoing cardiac surgery involving a median sternotomy
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CefazolinIntravenous administration of 2 g cefazolin | Drug | Intraoperative and 24-hours Postoperative Surgical Antimicrobial Prophylaxis Arm, Intraoperative and 48-hours Postoperative Surgical Antimicrobial Prophylaxis Arm |
| Water for injectionIntravenous administration of 10mL sterile water for injection | Drug | Intraoperative and 24-hours Postoperative Surgical Antimicrobial Prophylaxis Arm, Intraoperative only Surgical Antimicrobial Prophylaxis Arm |
Primary outcome
Incidence of surgical site infection
Time frame: 90 days from index surgery
Surgical site infection according to CDC / NHSN definition
2 secondary outcomes
Incidence of Clostridioides difficile infection
Time frame: 30 days from index surgery
Incidence of other health care association infections
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2026.
- Derived from this study: PubMed 41857861Peel T, McGiffin D, Smith J, Forbes A, Marasco S, Pilcher D, Stewardson AJ, Petrie D, Peleg AY, Wisniewski J, Forster S, Druce P, Roney J, Astbury S, Berkovic D, Mccracken P, Myles PS; CALIPSO Trial Steering Committee. Multicentre, adaptive, double-blind, three-arm, placebo-controlled, non-inferiority trial examining antimicrobial prophylaxis duration in cardiac surgery (CALIPSO): trial protocol. BMJ Open. 2026 Mar 18;16(3):e115209. doi: 10.1136/bmjopen-2025-115209.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Trisha Peel, MBBS GradCertRes FRACP PhD principal investigator
Monash University
27 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Cefazolin and Water for injection in people with Surgical Site Infection, run by Monash University at 27 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites in Australia, New Zealand, Malaysia, United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Paige Druce, MSc(Epi) (9903 0016 ext. +61 3, paige.druce@monash.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of surgical site infection (time frame: 90 days from index surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05447559, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2026.