NCT05447559

Duration of Cardiac Antimicrobial Prophylaxis Outcomes Study

Multicentre, Adaptive, Double-blind, Three-arm, Placebo-controlled, Noninferiority Trial Examining Antimicrobial Prophylaxis Duration in Cardiac Surgery

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 9,180 (estimated)
• Sponsor: Monash University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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

Conditions

• Surgical Site Infection

Interventions

Type	Name	Description
DRUG	Cefazolin	Intravenous administration of 2 g cefazolin
DRUG	Water for injection	Intravenous administration of 10mL sterile water for injection

Timeline

• Start date: 2023-02-07
• Primary completion: 2027-12-01
• Completion: 2028-06-01
• First posted: 2022-07-07
• Last updated: 2026-03-25

Locations

27 sites across 5 countries: United States, Australia, Canada, Malaysia, New Zealand

Regulatory

• FDA-regulated drug study