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Recruiting Phase 4 NCT05447559

Duration of Cardiac Antimicrobial Prophylaxis Outcomes Study

Phase 4 – monitoring after market approval
Conditions: Surgical Site Infection

Sponsor: Monash University

trial.available_in: БГ
Overview
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
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
Who can participate
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
Locations 5
Australia (1)
Westmead Hospital
Sydney , New South Wales
Canada (1)
Halifax Infirmary
Halifax , Nova Scotia
Malaysia (1)
IJN
Kuala Lumpur
New Zealand (1)
Christchurch Hospital
Christchurch
United States (1)
UT Southwestern Medical Centre
Dallas , Texas
NOT_YET_RECRUITING
Technical details
Status
Recruiting
Phase
Phase 4
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
07.02.2023
Completion date
01.06.2028
Registry ID
NCT05447559
Source
anzctr
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