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New treatment option for Surgical Site Infection
Official title Duration of Cardiac Antimicrobial Prophylaxis Outcomes Study
ClinicalTrials.gov ID: NCT05447559
What this study is testing
What is Cefazolin?
Cefazolin is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for surgical site infection.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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
- Phase 4: studies an already-approved treatment
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- \- Adult patients undergoing cardiac surgery involving a median sternotomy
You likely can't join if
- Age \<18 years
- American Society of Anesthesiology (ASA) 5
- people 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
See the full eligibility criteria
- \- Adult patients undergoing cardiac surgery involving a median sternotomy
- Age \<18 years
- American Society of Anesthesiology (ASA) 5
- people 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 assigned by chance to the CALIPSO trial
The study team makes the final eligibility decision.
Where it's taking place
- Dallas, Texas, United States
- Sydney, New South Wales, Australia
- Brisbane, Queensland, Australia
- Adelaide, South Australia, Australia
- Hobart, Tasmania, Australia
- Melbourne, Victoria, Australia
- Nedlands, Western Australia, Australia
- Perth, Western Australia, Australia
- Melbourne, Australia
- Halifax, Nova Scotia, Canada
- Kuala Lumpur, Malaysia
- Christchurch, New Zealand
- Hamilton, New Zealand
- Wellington, New Zealand
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Dallas, Texas, United States; Sydney, New South Wales, Australia; Brisbane, Queensland, Australia; Adelaide, South Australia, Australia; Hobart, Tasmania, Australia; Melbourne, Victoria, Australia and 8 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.