Prevention of Infections in Cardiac Surgery (PICS): a Cluster-randomized Factorial Cross-over Trial

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorHamilton Health Sciences Corporation

About this trial

The goal of this pragmatic, multi-centre factorial cluster randomized cross-over trial is to assess the efficacy of a combination of cefazolin plus vancomycin compared to cefazolin monotherapy, as well as a comparison of short versus long-term prophylaxis with four study arms: 1) cefazolin short-term, 2) cefazolin long-term, 3) cefazolin plus vancomycin short-term and 4) cefazolin plus vancomycin long-term.

Eligibility criteria

Qualifiers

None

Disqualifiers

On systemic antibiotics or with an active bacterial infection at the time of surgery

Previously enrolled in this trial

Known to be colonized with methicillin-resistant staphylococcus aureus (MRSA). Where it is unethical to not administer glycopeptides.

Beta-lactam or vancomycin allergy precluding the use of cefazolin or vancomycin, respectively

Trial design

Treatments tested in this trial

  • Cefazolin
  • Vancomycin

Treatment groups

38,000 Participants
are divided into 4 treatment groups

Locations

This trial has no locations

Sponsors and collaborators

Hamilton Health Sciences Corporation

Lead sponsor

Canadian Institutes of Health Research (CIHR)

Collaborator