Duration of Cardiac Antimicrobial Prophylaxis Outcomes Study

NCT05447559 | Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: 228/22
• Study Type: interventional
• Target: 9,180
• Locations: 5 countries
• Sites: 27

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

Conditions

Surgical Site Infection

Keywords

Cardiac surgery

Outcome Measures

Primary Outcomes (1)

• Incidence of surgical site infection

  Surgical site infection according to CDC / NHSN definition

  90 days from index surgery

Secondary Outcomes (2)

• Incidence of Clostridioides difficile infection

  30 days from index surgery

• Incidence of other health care association infections

  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 (4)

• Incidence of Antimicrobial hypersensitivity reactions

  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

• All-cause mortality rate

  180 days from index surgery

• Incidence of acute kidney injury

  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

Study Arms (3)

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

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)

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

Drug: Cefazolin

Interventions

Cefazolin DRUG

Intravenous administration of 2 g cefazolin

Intraoperative and 24-hours Postoperative Surgical Antimicrobial Prophylaxis Arm; Intraoperative and 48-hours Postoperative Surgical Antimicrobial Prophylaxis Arm

Water for injection DRUG

Intravenous administration of 10mL sterile water for injection

Intraoperative and 24-hours Postoperative Surgical Antimicrobial Prophylaxis Arm; Intraoperative only Surgical Antimicrobial Prophylaxis Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Adult patients undergoing cardiac surgery involving a median sternotomy

You may not qualify if:

• 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

Sponsors & Collaborators

• Monash University: lead
• ANZCA CTN: collaborator

Study Sites (27)

UT Southwestern Medical Centre

Dallas, Texas, 75390, United States

NOT YET RECRUITING

Westmead Hospital

Sydney, New South Wales, 2145, Australia

RECRUITING

St George Hospital

Sydney, New South Wales, 2217, Australia

ACTIVE NOT RECRUITING

The Prince Charles Hospital

Brisbane, Queensland, 4032, Australia

RECRUITING

Princess Alexandra Hospital

Brisbane, Queensland, 4102, Australia

RECRUITING

St Andrew's War Memorial Hospital

Brisbane, Queensland, Australia

ACTIVE NOT RECRUITING

Royal Adelaide Hospital

Adelaide, South Australia, 5000, Australia

RECRUITING

Flinders Medical Centre

Adelaide, South Australia, 5042, Australia

RECRUITING

Flinders Private

Adelaide, South Australia, 5042, Australia

RECRUITING

Royal Hobart Hospital

Hobart, Tasmania, 7000, Australia

RECRUITING

The Alfred Hospital

Melbourne, Victoria, 3004, Australia

RECRUITING

The Royal Melbourne Hospital

Melbourne, Victoria, 3050, Australia

RECRUITING

Austin Health

Melbourne, Victoria, 3084, Australia

RECRUITING

Epworth HealthCare

Melbourne, Victoria, 3121, Australia

RECRUITING

Cabrini Health

Melbourne, Victoria, 3144, Australia

RECRUITING

Victorian Heart Hospital

Melbourne, Victoria, 3168, Australia

RECRUITING

Sir Charles Gairdner

Nedlands, Western Australia, Australia

NOT YET RECRUITING

St John of God Subiaco Hospital

Perth, Western Australia, 6008, Australia

RECRUITING

Fiona Stanley Hospital

Perth, Western Australia, Australia

RECRUITING

St Vincent's Hospital

Melbourne, Australia

RECRUITING

Halifax Infirmary

Halifax, Nova Scotia, Canada

RECRUITING

IJN

Kuala Lumpur, Malaysia

RECRUITING

UMMC

Kuala Lumpur, Malaysia

NOT YET RECRUITING

Christchurch Hospital

Christchurch, New Zealand

RECRUITING

Waikato Hospital

Hamilton, 3204, New Zealand

RECRUITING

Wakefield Hospital

Wellington, New Zealand

NOT YET RECRUITING

Wellington Hospital

Wellington, New Zealand

RECRUITING

Related Publications (1)

• 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.

  PMID: 41857861 DERIVED

MeSH Terms

Conditions

Surgical Wound Infection

Interventions

Cefazolin; Water; Injections

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cephalosporins; beta-Lactams; Lactams; Amides; Organic Chemicals; Thiazines; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds; Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Trisha Peel, MBBS GradCertRes FRACP PhD

  Monash University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Paige Druce, MSc(Epi)

CONTACT

9903 0016; paige.druce@monash.edu

Sarah Astbury

CONTACT

9076 6071; sarah.astbury@monash.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Trisha Peel

Model Details: Adaptive, double-blind, three-arm, placebo-controlled, phase IV, noninferiority trial

Study Record Dates

• First Submitted: June 27, 2022
• First Posted: July 7, 2022
• Study Start: February 7, 2023
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): June 1, 2028
• Last Updated: March 25, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

NZ (4); CA (1); MY (2); US (1); AU (19)