An interventional study of Simplified layered consent form and Full-length consent form in Staphylococcus Aureus Bacteremia, sponsored by Sunnybrook Health Sciences Centre. Completed at 6 sites in Canada. Per ClinicalTrials.gov, last updated 2026-10-19.
Sponsored by Sunnybrook Health Sciences Centre · Not applicable, Interventional, and Health services research
Among 21 studies in Bacteremia with a site in Canada — 5 open to participants now, 6 under way, none of them phase 3. Bacteremia · Canada.
Among the 21 studies in Bacteremia with a site in Canada, this one is the 6th largest by enrollment of the 19 interventional ones, is one of 2 that started in 2023, is one of 12 with no phase, and was the 15th registered.
297 studies on the registry are indexed under Bacteremia; 51 are open to participants now.
This study's enrollment of 347 is above the median of 156 across 156 interventional studies indexed under Bacteremia.
Browse Bacteremia studies →5 of the 21 studies in Bacteremia with a site in Canada are open now, in 5 countries. Each count lists the studies.
Of the 40 Bacteremia studies recruiting now, 32 (80%) set no upper age limit and 4 (10%) stop at 75 or younger; 11 take children under 18; 2 take healthy volunteers.
This study: all sexes · no healthy volunteers.
The full table on the hub →21 studies; the count open now beside each. This study's row is marked.
First in 2006; this study’s year is marked. 2 started in 2023.
Median enrollment 200 across the 19 interventional studies, 350 across the 2 observational. Of the 12 that completed or were terminated, 1 (8%) have results posted.
None of the 21 has an industry lead sponsor. The 10 most frequent:
Sunnybrook Health Sciences Centre is the lead sponsor of 584 studies on the registry; 135 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 2 (33%) have results posted.
Sunnybrook Health Sciences Centre has 6 studies filed under Bacteremia — fewer than ten, so there is no comparison to draw.
3 of the studies in Bacteremia with a site in Canada that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT03671967Rambam Health Care CampusPipEracillin Tazobactam Versus mERoPENem for Treatment of Bloodstream Infections Caused by Cephalosporin-resistant Enterobacteriaceae (PETERPEN) | 2027-01-01 |
| NCT04886284Todd C. Lee MD MPH FIDSACombination Cefazolin With Ertapenem for Methicillin-susceptible Staphylococcus Aureus Bacteremia | 2027-04 |
| NCT06537609Sunnybrook Health Sciences CentreA Platform Trial for Gram Negative Bloodstream Infections | 2027-04 |
Among the 21 studies in Bacteremia with a site in Canada, from their registry updates:
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 trial of treatment of Staphylococcus aureus bloodstream infection (the SNAP trial).
The main questions it aims to answer are:
Participants will be randomized to either the full-length informed consent form or the simplified layered consent form containing links to optional supplementary information or videos. Research staff will use the assigned form to explain the SNAP trial to participants. After consent, participants will be evaluated on their understanding of the SNAP trial and satisfaction with the consent process using a questionnaire.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
All inclusion criteria from the larger SNAP trial:
Specific additional inclusion criteria for SIMPLY-SNAP:
Exclusion Criteria:
All exclusion criteria from larger SNAP trial:
For participants randomized to the SIMPLY-SNAP experimental group, a simplified layered consent process will be used to explain information for the SNAP trial. The research staff member obtaining consent will provide a standardized explanation, providing summarized information in simple English or French contained in a 4-page concise participant information sheet. Throughout the consent process, the research staff member will answer any questions that the participant has, to reflect routine consent discussion practice.
Other: Simplified layered consent form
For participants randomized to the control group, the existing consent process will be used including going through the currently approved full-length informed consent form. The research staff member will provide an explanation using the full-length informed consent form as per standard clinical trial procedures. Similarly, throughout the consent process, the research staff member will answer any participant questions as per normal procedures.
Other: Full-length consent form
The simplified consent form includes all essential elements of trial consent including an explanation of the trial procedures, data and sample collection, and follow-up information. The form also outlines important ethical considerations for patients, such as confidentiality, regulatory and safety requirements, the ability to drop out, and the necessary process and contact numbers for grievances or feedback. In addition to the text, the form includes links to additional written information and videos that can be accessed on top of the simplified informed consent form (i.e., the additional layers in the layered consent process). These materials are hosted on the main SNAP trial website (https://www.snaptrial.com.au/patients) and are available in English and French. Participants will be able to access these directly through embedded hyperlinks using provided electronic tablets.
The full-length informed consent form contains all information upfront. Links to additional information will not be provided on the form but are freely available on the Internet should the participant wish to access them.
Proportion of patients recruited to SNAP
The number of patients who consented and were randomized in the SNAP trial, divided by the total number of patient eligible for the SNAP trial and randomized in SIMPLY-SNAP.
Time frame: 1 day
Participant understanding of the clinical trial
Understanding of the clinical trial will be measured by a modified Consent Understanding Evaluation (CUE) tool. This is a questionnaire that comprises a list of open and closed-ended questions designed to evaluate a participant's understanding of the clinical trial they just enrolled in. It is adapted from previous similar trials evaluating adjunctive consent interventions but modified to the context of SNAP. The score ranges from 0 (worst understanding) to 15 (best understanding).
Time frame: Within 3 days after the consent process
Participant satisfaction with the consent process
Scored by 11-point Likert scale (0 to 10; 0 being not satisfied at all and 10 being extremely satisfied).
Time frame: Within 3 days after the consent process
Research staff satisfaction with the consent process
Scored by 11-point Likert scale (0 to 10; 0 being not satisfied at all and 10 being extremely satisfied).
Time frame: 1 day
Time taken for entire consent process
In minutes
Time frame: 1 day
Diversity of enrolled trial population
As an exploratory outcome, we will also evaluate diversity of the enrolled trial population across five self-reported socio-demographic characteristics: gender, ethnicity, primary spoken language, socioeconomic status (measured by income level, or last-income level before retirement), and highest formal educational level attained. We will separately evaluate diversity of the patient group enrolled in SNAP via the simplified consent process versus the patient group enrolled via the full-length consent form. Diversity will be measured using the Simpson's Diversity Index (SDI). SDI will be calculated for each of five socio-demographic variables for the group recruited via simplified consent and the group recruited via conventional consent. A composite diversity score for each group combining the SDIs of all five variables will also be calculated.
Time frame: End of the entire SIMPLY-SNAP study
Plan to share: No
Ran from Nov 2023 to primary completion in Apr 2026, 28 months.
Of 34 non-industry interventional studies with no phase under Bacteremia, half reached primary completion within 34 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 64. This study's 28 months is below that.
Counting every sponsor, half of 35 studies reached it within 34 months; a quarter within 13 and three quarters within 64.
Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 19, 2026: primary completion Jun 2026 → Apr 2026 and completion Jun 2026 → Apr 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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