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Recruiting NCT05447559

Duration of Cardiac Antimicrobial Prophylaxis Outcomes Study

Phase IV Interventional Surgical Site Infection

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Cefazolin, Water for injection.
Who it may be relevant to
Registry conditions: Surgical Site Infection. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Australia, Canada, Malaysia, New Zealand
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

Interventions

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

Primary outcome measures

  • Incidence of surgical site infection [Time frame: 90 days from index surgery]
Secondary outcome measures (2)
  • Incidence of Clostridioides difficile infection [Time frame: 30 days from index surgery]
  • Incidence of other health care association infections [Time frame: From date of randomization until the date of discharge from the acute healthcare facility or date of death from any cause, whichever came first, assessed up to 30 days from index surgery]

Eligibility criteria

Inclusion criteria

\- Adult patients undergoing cardiac surgery involving a median sternotomy

Exclusion criteria

  • Age <18 years
  • American Society of Anesthesiology (ASA) 5
  • Subjects 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 randomised to the CALIPSO trial

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Prevention

Study locations

Australia · 19 centers
  • Westmead Hospital — Sydney
  • St George Hospital — Sydney
  • The Prince Charles Hospital — Brisbane
  • Princess Alexandra Hospital — Brisbane
  • St Andrew's War Memorial Hospital — Brisbane
  • Royal Adelaide Hospital — Adelaide
  • Flinders Medical Centre — Adelaide
  • Flinders Private — Adelaide
  • … and 11 more centers
New Zealand · 4 centers
  • Christchurch Hospital — Christchurch
  • Waikato Hospital — Hamilton
  • Wakefield Hospital — Wellington
  • Wellington Hospital — Wellington
Malaysia · 2 centers
  • IJN — Kuala Lumpur
  • UMMC — Kuala Lumpur
United States · 1 center
  • UT Southwestern Medical Centre — Dallas
Canada · 1 center
  • Halifax Infirmary — Halifax

Publications

  • Peel T, McGiffin D, Smith J, Forbes A, Marasco S, Pilcher D, Stewardson AJ, Petrie D, Peleg AY, Wisniewski J, Forster S, Druce P, Roney J, Astbury S, Berkovic D, Mccracken P, Myles PS; CALIPSO Trial Steering Committee. Multicentre, adaptive, double-blind, three-arm, placebo-controlled, non-inferiority trial examining antimicrobial prophylaxis duration in cardiac surgery (CALIPSO): trial protocol. PMID 41857861

Identifiers

NCT: NCT05447559 · 228/22

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗