SepsisCOMPASS-INCT07874698
Clinical Outcomes Using Molecular Prediction in Acute Suspected Sepsis and Infection
An observational study of Sepsis, run by Unity Health Toronto.
Trial summary
Sepsis is a complex syndrome that affects the functioning of multiple organ systems and is caused by an uncontrolled response to infection. Sepsis is usually diagnosed with a physical examination and evaluation of symptoms followed by lab tests to look at how different organ systems are functioning and to look for… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sepsis
- How many people
- 400 participants
- Where
- No sites listed yet
- Study dates
- 21 Oct 2026to 21 Dec 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with suspicion of infection
Who may be able to join
- Adult patients 18 years of age or older
- Suspicion of infection - as defined by:
- Physician documentation of suspected infection. OR
- Initiation of a sepsis-related diagnostic or treatment pathway within 24 hours of presentation
- OR
- EPIC - ALERT System Identifies patient as risk for Sepsis AND
Show all 11Show fewer
- Lactate ≥3 OR pH ≤7.35 and at least 2 of the following SIRS Criteria that cannot be explained by another diagnosis:
- Temperature >38.3°C or <35°C
- Heart Rate >110 bpm
- Respiratory Rate >25 or PaCO2 <32 mmHg
- WBC >12,000 mm3, <4000 mm3, or 10% immature (band) forms
Who cannot join
- Patients with Do Not Resuscitate and Do Not Intubate orders
- EAA Sub-Study: Patients with Leukopenia (leukocyte count <500 cells/mm3) will be excluded. These patients can still be enrolled in the trial.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Sepsis is a complex syndrome that affects the functioning of multiple organ systems and is caused by an uncontrolled response to infection. Sepsis is usually diagnosed with a physical examination and evaluation of symptoms followed by lab tests to look at how different organ systems are functioning and to look for signs of infection, which can take up to 3 days. There aren't currently any tests that allow doctors to predict patient outcome, hospital course, or severity of illness. Our team has identified a set of genes that when combined can predict the likelihood of clinical deterioration; this set of genes is called SEPSET. In this study the investigators will evaluate the predictive capability of SEPSET along with clinical and laboratory measures in patients with suspected infection.
Read the detailed description
The investigators are studying a novel and contemporary paradigm for the management of critically ill patients using molecular (RNA)-based biomarkers to predict clinical deterioration in patients with suspected sepsis.
Building on a successful collaboration with the National Research Council of Canada (NRC), supported by NRC Pandemic Research Challenge Program, by a Natural Sciences and Engineering Research Council of Canada (NSERC) and Canadian Institute of Health Research (CIHR) collaborative grant (CHRP) and Project Grant, our team has developed an RNA-based classifier composed of 4 genes and 2 house-keeping genes (SEPSET) that together, predict the likelihood of clinical deterioration.
In this study, the investigators will prospectively evaluate, compare and combine assessment of the predictive capability of SEPSET, clinical, and laboratory measures to identify patients with suspected sepsis at increased risk for future deterioration, as defined by any of the following: intensive care unit (ICU) admission, initiation of respiratory support (non-invasive ventilatory support), endotracheal intubation, administration of vasopressors/inotropes, or death within the first 72 hours of presentation. Results from SEPSET will be correlated with clinical trajectories evaluated across key clinically relevant endpoints: ventilator liberation, ventilator-free days, duration of mechanical ventilation, ICU length of stay, hospital length of stay, and death at 28-days and 90-days.
- Conditions
- Sepsis
- Keywords
- Suspected Infection, Sepsis
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| ICU | Patients admitted to the Medical Surgical Intensive Care Unit (MSICU) with suspected infection. | |
| Ward | Patients admitted to General Internal Medicine (GIM) and General Surgery (GS) with suspected infection. | |
| ED | Patients presenting to the Emergency Department (ED) with suspected infection. | |
| Non-Septic Control | Healthy participants and patients with without infection. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent accuracy of the SEPSET 6 gene classifier to predict clinical deterioration when compared to documented clinical deterioration in patients medical charts
Prospective evaluation, comparison, and combinatorial predictive capability of the SEPSET classifier, clinical, and laboratory measures within 24h of presentation, to identify patients with suspected sepsis at increased risk for future deterioration: as defined by any of the following: ICU admission, initiation of respiratory support (mechanical ventilation - non-invasive), endotracheal intubation, administration of vasopressors/inotropes, or death within the first 72h of presentation.
The investigators will perform RNA sequencing of 6 genes that have been found to be able to predict clinical deterioration when combined. The likelihood of clinical deterioration determined by using this set of genes will then be compared to actual rates of clinical deterioration based on documented information in the patients medical chart such as need for various types of organ support.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2026
- Study start21 Oct 2026 (estimated)
- Primary completion21 Dec 2028 (estimated)
- Study completion21 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SepsisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Spectral Diagnostics (US) Inc., National Research Council Canada, University of British Columbia, Simon Fraser University
- Responsible party
- Principal investigator, Claudia DosSantos, Unity Health Toronto
- Investigators
- Claudia dos Santos, MD, Principal investigator, Unity Health Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07874698
- Sponsor's protocol ID
- COMPASS-1 v.1 July 10 2026
- Acronym
- COMPASS-I
- Status last verified
- Oct 2026
- First submitted
- 30 Sep 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Demographics and Comorbidities - At Enrollment * Age and biological sex * Self-reported gender * Race or ethnicity * Past medical history, noting specifically whether the patient has any pre-existing respiratory, cardiovascular, or renal disease * Medications at the time of enrollment * Previous surgeries * Height and admission weight * Date of symptom onset * Charlson Comorbidity Index * Clinical Frailty Scale Physiologic Data - At Enrollment and Daily until day 7 and every 2 weeks until hospital discharge or death * Heart rate and rhythm at the time of sample collection or 8am on days when samples are not collected. Maximum and minimum heart rate as well as any documented arrhythmias in the preceding 24 hours * Blood pressure and management strategies (i.e. blood pressure medication and dose) at the time of collection or 8am on days when samples are not collected. Maximum and minimum blood pressure in the preceding 24 hours * Temperature and management strategies (i.e. paracetamol,
Publications
https://doi.org/10.1038/s41467-025-59227-x
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Outcomes Using Molecular Prediction in Acute Suspected Sepsis and Infection
- ClinicalTrials.gov ID
- NCT07874698
- Acronym / sponsor ID
- COMPASS-I / COMPASS-1 v.1 July 10 2026
- Conditions
- Sepsis
- Keywords
- Suspected Infection, Sepsis
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Collaborators
- Spectral Diagnostics (US) Inc., National Research Council Canada, University of British Columbia, Simon Fraser University
- Study start
- 21 Oct 2026 (estimated)
- Primary completion
- 21 Dec 2028 (estimated)
- Study completion
- 21 Dec 2029 (estimated)
- First posted
- 15 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Sepsis is a complex syndrome that affects the functioning of multiple organ systems and is caused by an uncontrolled response to infection. Sepsis is usually diagnosed with a physical examination and evaluation of symptoms followed by lab tests to look at how different organ systems are functioning and to look for signs of infection, which can take up to 3 days. There aren't currently any tests that allow doctors to predict patient outcome, hospital course, or severity of illness. Our team has identified a set of genes that when combined can predict the likelihood of clinical deterioration; this set of genes is called SEPSET. In this study the investigators will evaluate the predictive capability of SEPSET along with clinical and laboratory measures in patients with suspected infection.
Detailed description
The investigators are studying a novel and contemporary paradigm for the management of critically ill patients using molecular (RNA)-based biomarkers to predict clinical deterioration in patients with suspected sepsis.
Building on a successful collaboration with the National Research Council of Canada (NRC), supported by NRC Pandemic Research Challenge Program, by a Natural Sciences and Engineering Research Council of Canada (NSERC) and Canadian Institute of Health Research (CIHR) collaborative grant (CHRP) and Project Grant, our team has developed an RNA-based classifier composed of 4 genes and 2 house-keeping genes (SEPSET) that together, predict the likelihood of clinical deterioration.
In this study, the investigators will prospectively evaluate, compare and combine assessment of the predictive capability of SEPSET, clinical, and laboratory measures to identify patients with suspected sepsis at increased risk for future deterioration, as defined by any of the following: intensive care unit (ICU) admission, initiation of respiratory support (non-invasive ventilatory support), endotracheal intubation, administration of vasopressors/inotropes, or death within the first 72 hours of presentation. Results from SEPSET will be correlated with clinical trajectories evaluated across key clinically relevant endpoints: ventilator liberation, ventilator-free days, duration of mechanical ventilation, ICU length of stay, hospital length of stay, and death at 28-days and 90-days.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| ICU | – | –Patients admitted to the Medical Surgical Intensive Care Unit (MSICU) with suspected infection. |
| Ward | – | –Patients admitted to General Internal Medicine (GIM) and General Surgery (GS) with suspected infection. |
| ED | – | –Patients presenting to the Emergency Department (ED) with suspected infection. |
| Non-Septic Control | – | –Healthy participants and patients with without infection. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with suspicion of infection
Key inclusion criteria (11 listed)
- Adult patients 18 years of age or older
- Suspicion of infection - as defined by:
- Physician documentation of suspected infection. OR
- Initiation of a sepsis-related diagnostic or treatment pathway within 24 hours of presentation
- OR
Key exclusion criteria (2 listed)
- Patients with Do Not Resuscitate and Do Not Intubate orders
- EAA Sub-Study: Patients with Leukopenia (leukocyte count <500 cells/mm3) will be excluded. These patients can still be enrolled in the trial.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Percent accuracy of the SEPSET 6 gene classifier to predict clinical deterioration when compared to documented clinical deterioration in patients medical charts
Time frame: 2 years
Prospective evaluation, comparison, and combinatorial predictive capability of the SEPSET classifier, clinical, and laboratory measures within 24h of presentation, to identify patients with suspected sepsis at increased risk for future deterioration: as defined by any of the following: ICU admission, initiation of respiratory support (mechanical ventilation - non-invasive), endotracheal intubation, administration of vasopressors/inotropes, or death within the first 72h of presentation. The investigators will perform RNA sequencing of 6 genes that have been found to be able to predict clinical deterioration when combined. The likelihood of clinical deterioration determined by using this set of genes will then be compared to actual rates of clinical deterioration based on documented information in the patients medical chart such as need for various types of organ support.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
- Backgroundhttps://doi.org/10.1038/s41467-025-59227-x
- Individual participant dataSharing planned: Undecided. Demographics and Comorbidities - At Enrollment * Age and biological sex * Self-reported gender * Race or ethnicity * Past medical history, noting specifically whether the patient has any pre-existing respiratory, cardiovascular, or renal disease * Medications at the time of enrollment * Previous surgeries * Height and admission weight * Date of symptom onset * Charlson Comorbidity Index * Clinical Frailty Scale Physiologic Data - At Enrollment and Daily until day 7 and every 2 weeks until hospital discharge or death * Heart rate and rhythm at the time of sample collection or 8am on days when samples are not collected. Maximum and minimum heart rate as well as any documented arrhythmias in the preceding 24 hours * Blood pressure and management strategies (i.e. blood pressure medication and dose) at the time of collection or 8am on days when samples are not collected. Maximum and minimum blood pressure in the preceding 24 hours * Temperature and management strategies (i.e. paracetamol,
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Claudia dos Santos, MD principal investigator
Unity Health Toronto
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis, run by Unity Health Toronto.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eryn Churcher (416-864-6060 ext. 40387, eryn.churcher@unityhealth.to), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent accuracy of the SEPSET 6 gene classifier to predict clinical deterioration when compared to documented clinical deterioration in patients medical charts (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07874698, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026.