Status:
RECRUITING
Evaluating Simplified Layered Consent for Clinical Trials
Lead Sponsor:
Sunnybrook Health Sciences Centre
Collaborating Sponsors:
McGill University Health Centre/Research Institute of the McGill University Health Centre
Conditions:
Staphylococcus Aureus Bacteremia
Eligibility:
All Genders
Phase:
NA
Brief Summary
The goal of this clinical trial (the SIMPLY-SNAP trial) is to compare a simplified layered consent form to a full-length consent form for use during the informed consent process for a larger clinical ...
Eligibility Criteria
Inclusion
- All inclusion criteria from the larger SNAP trial:
- S. aureus complex grown from ≥1 blood culture
- Admitted to a participating hospital at the time of eligibility assessment
- Specific additional inclusion criteria for SIMPLY-SNAP:
- Admitted to participating hospital of SIMPLY-SNAP
- Self-reported proficiency in English or French adequate to be able to participate in consent process carried out solely in English or French (as the supplementary consent materials required in the simplified consent process are currently only available in these two languages)
Exclusion
- All exclusion criteria from larger SNAP trial:
- Time of anticipated platform entry is greater than 72 hours post collection of the index blood culture
- Polymicrobial bacteremia, defined as more than one organism in the index blood cultures, excluding those organisms judged to be contaminants by either the microbiology laboratory or treating clinician
- Patient currently being treated with a systemic antibacterial agent that cannot be ceased
- Known previous participation in SNAP
- Known positive blood culture for S. aureus between 72 hours and 180 days prior to the time of eligibility assessment
- Treating team deems enrolment in the study is not in the best interest of the patient
- Treating team believes that death is imminent and inevitable
- Patient is for end-of-life care and antibiotic treatment is considered inappropriate
- Patient \<18 years of age and paediatric recruitment not approved at recruiting site
- Specific additional exclusion criteria for SIMPLY-SNAP: None
Key Trial Info
Start Date :
November 28 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2026
Estimated Enrollment :
346 Patients enrolled
Trial Details
Trial ID
NCT06168474
Start Date
November 28 2023
End Date
June 1 2026
Last Update
May 15 2025
Active Locations (6)
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1
University of Calgary, Foothills Medical Centre, Peter Lougheed Centre, Rockyview Hospital, South Health Campus
Calgary, Alberta, Canada
2
Hamilton General Hospital
Hamilton, Ontario, Canada
3
The Ottawa Hospital
Ottawa, Ontario, Canada
4
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N3M5