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Duration of Cardiac Antimicrobial Prophylaxis Outcomes Study

NCT05447559 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 9180

Last updated 2026-03-25

No results posted yet for this study

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

Conditions

  • Surgical Site Infection

Interventions

DRUG

Cefazolin

Intravenous administration of 2 g cefazolin

DRUG

Water for injection

Intravenous administration of 10mL sterile water for injection

Sponsors & Collaborators

Principal Investigators

  • Trisha Peel, MBBS GradCertRes FRACP PhD · Monash University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-07
Primary Completion
2027-12-31
Completion
2028-06-30
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Canada
  • Malaysia
  • New Zealand

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05447559 on ClinicalTrials.gov