Duration of Cardiac Antimicrobial Prophylaxis Outcomes Study

Part of paid clinical trials in Dallas, Texas.

Sponsor
Monash University
Study ID
NCT05447559
Phase
PHASE4
Status
Recruiting
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Conditions

  • Surgical Site Infection

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Cefazolin — DRUG
    Intravenous administration of 2 g cefazolin
  • Water for injection — DRUG
    Intravenous administration of 10mL sterile water for injection

Study Details

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

Key Dates

Start date
Feb 7, 2023
Status verified
Mar 2026
Primary completion
Dec 31, 2027
Completion
Jun 30, 2028

Study Design

Enrollment
9,180 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Placebo Comparator: Intraoperative only Surgical Antimicrobial Prophylaxis Arm
    Placebo administered every 8-hours following the preoperative dose (time=0) for a total of five postoperative doses
  • Other: Intraoperative and 24-hours Postoperative Surgical Antimicrobial Prophylaxis Arm
    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)
  • Active Comparator: Intraoperative and 48-hours Postoperative Surgical Antimicrobial Prophylaxis Arm
    Cefazolin (2g) administered every 8-hours following the preoperative dose (time=0) for a total of five postoperative doses

Primary Outcome Measure

Incidence of surgical site infection [ Time Frame: 90 days from index surgery ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
UT Southwestern Medical CentreDallasTexas75390
Dr Markus Velten

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UT Southwestern Medical Centre· Dallas, TX

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