Duration of Cardiac Antimicrobial Prophylaxis Outcomes Study (CALIPSO)

Monash University

Status and phase: Enrolling; Phase 4

Conditions: Surgical Site Infection

Treatments: Drug: Water for injection; Drug: Cefazolin

Study type: Interventional

Funder types: Other

Identifiers

NCT05447559

228/22

Details and patient eligibility

About

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

Full 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

Enrollment: 9,180 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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9,180 participants in 3 patient groups, including a placebo group

Intraoperative only Surgical Antimicrobial Prophylaxis Arm

Placebo Comparator group

Description:

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

Treatment:

Drug: Water for injection

Intraoperative and 24-hours Postoperative Surgical Antimicrobial Prophylaxis Arm

Other group

Description:

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)

Treatment:

Drug: Cefazolin

Drug: Water for injection

Intraoperative and 48-hours Postoperative Surgical Antimicrobial Prophylaxis Arm

Active Comparator group

Description:

Cefazolin (2g) administered every 8-hours following the preoperative dose (time=0) for a total of five postoperative doses

Treatment:

Drug: Cefazolin