Duration of Cardiac Antimicrobial Prophylaxis Outcomes Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

9180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-07

Study Completion Date

2027-06-30

Brief Summary

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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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Detailed Description

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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

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Surgical Site Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

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.

Study Groups

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Intraoperative only Surgical Antimicrobial Prophylaxis Arm

Placebo administered every 8-hours following the preoperative dose (time=0) for a total of five postoperative doses

Group Type PLACEBO_COMPARATOR

Water for injection

Intervention Type DRUG

Intravenous administration of 10mL sterile water for injection

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)

Group Type OTHER

Cefazolin

Intervention Type DRUG

Intravenous administration of 2 g cefazolin

Water for injection

Intervention Type DRUG

Intravenous administration of 10mL sterile water for injection

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

Group Type ACTIVE_COMPARATOR

Cefazolin

Intervention Type DRUG

Intravenous administration of 2 g cefazolin

Interventions

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Cefazolin

Intravenous administration of 2 g cefazolin

Intervention Type DRUG

Water for injection

Intravenous administration of 10mL sterile water for injection

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Trisha Nicole Peel

Professor Trisha Peel

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Trisha Peel, MBBS GradCertRes FRACP PhD

Role: PRINCIPAL_INVESTIGATOR

Monash University

Locations

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Westmead Hospital

Sydney, New South Wales, Australia

Site Status RECRUITING

St George Hospital

Sydney, New South Wales, Australia

Site Status ACTIVE_NOT_RECRUITING

The Prince Charles Hospital

Brisbane, Queensland, Australia

Site Status RECRUITING