Multicentre Adaptive Double-blind Placebo-controlled Trial Comparing Antimicrobial Prophylaxis Durations in Cardiac Surgery

What this Trial Is About

Researchers are studying the best duration of antimicrobial prophylaxis to prevent surgical site infections and other healthcare-associated infections in patients undergoing cardiac surgery involving a median sternotomy. This trial compares the effectiveness, health-economic impact, and microbiological effects of giving intravenous cefazolin during surgery only versus continuing it for 24 or 48 hours after surgery. The trial is a multicenter, adaptive, double-blind, three-arm, placebo-controlled, randomized phase IV study to assess non-inferiority among these approaches. Participants are randomly assigned to one of three groups: Arm A receives cefazolin only during the surgery with placebo afterward; Arm B receives cefazolin during surgery and for 24 hours postoperatively followed by placebo; Arm C receives cefazolin during surgery and for 48 hours after surgery. Cefazolin is given intravenously at a dose of 2 grams every 8 hours following the initial preoperative dose, with the number of postoperative doses varying by group. Placebo doses are administered to maintain blinding. During the study, participants will be monitored for surgical site infections up to 90 days after surgery, with additional assessments for Clostridioides difficile infection and other healthcare-associated infections up to 30 days post-surgery. Researchers will collect clinical and microbiological data, monitor health outcomes, and evaluate the economic impact of prophylaxis duration. The trial involves careful follow-up during hospitalization and after discharge, with the overall participation lasting at least 90 days post-surgery.

Duration of Cardiac Antimicrobial Prophylaxis Outcomes Study