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Duration of Cardiac Antimicrobial Prophylaxis Outcomes Study
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.
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.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
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
Find a site
Closest Location:
Westmead Hospital
Research sites nearby
Select from list below to view details:
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
| DRUG: Water for injection
|
OTHER: Intraoperative and 24-hours Postoperative Surgical Antimicrobial Prophylaxis Arm
| DRUG: Cefazolin
|
ACTIVE_COMPARATOR: Intraoperative and 48-hours Postoperative Surgical Antimicrobial Prophylaxis Arm
| DRUG: 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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