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Duration of Cardiac Antimicrobial Prophylaxis Outcomes Study

PHASE4RECRUITING

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.

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Study details:

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.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

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

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Eligibility

Age eligible for study : 18 and older

Healthy volunteers accepted : No

Gender eligible for study: All

Things to know

Study dates

Study start: 2023-02-07

Primary completion: 2027-01-01

Study completion finish: 2027-06-01

Study type

PREVENTION

Phase

PHASE4

Trial ID

NCT05447559

Intervention or treatment

DRUG: Cefazolin

DRUG: Water for injection

Conditions

• Surgical Site Infection

Image related to Surgical Site Infection

Condition: Surgical Site Infection
DRUG: Cefazolin and other drugs
Sydney, New South Wales, Australia and more
Sponsor: Monash University

You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.

Are you running this trial? If you're a clinic or sponsor, you can claim this study. Claim or learn more.

Find a site

Closest Location:

Westmead Hospital

Research sites nearby

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Westmead Hospital
Sydney, New South Wales, Australia
St George Hospital
Sydney, New South Wales, Australia
The Prince Charles Hospital
Brisbane, Queensland, Australia
Princess Alexandra Hospital
Brisbane, Queensland, Australia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/Arm	Intervention/Treatment
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	DRUG: Water for injection Intravenous administration of 10mL sterile water for injection
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)	DRUG: Cefazolin Intravenous administration of 2 g cefazolin
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	DRUG: Cefazolin Intravenous administration of 2 g cefazolin

What is the study measuring?

Primary outcome

Primary Outcome Measure	Primary Outcome Description	Primary Outcome Time Frame
Incidence of surgical site infection	Surgical site infection according to CDC / NHSN definition	90 days from index surgery

Secondary outcome

Secondary Outcome Measure	Secondary Outcome Description	Secondary Outcome Time Frame
Incidence of Clostridioides difficile infection	Clostridioides difficile infection according the CDC definitions	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)	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

Frequently Asked Questions

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References

Clinical Trials Gov: Duration of Cardiac Antimicrobial Prophylaxis Outcomes Study