SepsisTIMEDNCT06637904
TriVerity™ for Improved Management of Emergency Department (ED) Patients With Suspected Infections
A study testing TriVerity Test in people with Sepsis and Infections, run by Inflammatix at 2 sites in United States.
Trial summary
A pre/post interventional use trial, with ED patients who are initially triaged to locations other than a dedicated patient room in the main ED (e.g., waiting room, hallway bed, and/or the staging area/fast track area) with suspected infection and tachycardia or fever will be enrolled. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis, Infections, Tachycardia
- What is being tested?
- TriVerity Test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- 2 sitesUnited States
- Study dates
- 8 Nov 2024to 10 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years
- Participant presents to ED with ALL of the below:
- 2.1. Suspected acute infection (e.g., respiratory, urinary, abdominal, skin \& soft-tissue infection, meningitis/encephalitis, or any other infection), and 2.2. Either heart rate >100 beats per minute or/and temperature >38C. 2.3. NOT immediately roomed in a primary designated treatment location,( i.e., they can be in the waiting room, ED triage hallways, and/or ED staging area/fast track area).
- Able to provide informed consent, or consent by legally authorized representative.
- Reachable via confirmed working cell phone (with backup contact number) and willing to respond to follow-up safety checks (see below for details).
Who cannot join
- Patient-reported treatment with systemic antibiotics, systemic antiviral agents or systemic antifungal agents within the past 7 days prior to presentation in the waiting room of the ED. Participants will not be excluded for use of:
- Antiviral treatment for chronic viral infections, i.e., HIV, hepatitis B and hepatitis C
- Topical antibiotics, topical antivirals or topical antifungal agents
- Anti-herpes prophylaxis aiding suppression of a recuring herpes infection
- Single dose of one or combination of peri-operative (prophylactic) antibiotics
- Patients receiving palliative or hospice care, or those receiving limited interventional care (see Appendix B).
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- Prisoners, mentally disabled, or unable to give consent. Should the patient not be able to provide informed consent the legally authorized representative can provide the consent on behalf of the patient.
- Participants receiving experimental therapy or already enrolled in an interventional clinical trial in which a subject receives some type of intervention, which can include but is not limited to investigational drugs, medical devices, or vaccines. Participants that are enrolled in non-interventional or observational clinical trials will be allowed to participate in this clinical trial.
- Participants previously enrolled in the present clinical trial.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Johns Hopkins Department of Emergency Medicine
Baltimore, Maryland, 21287
OSF HealthCare Saint Francis Medical Center
Peoria, Illinois, 61637
About this study
A pre/post interventional use trial, with ED patients who are initially triaged to locations other than a dedicated patient room in the main ED (e.g., waiting room, hallway bed, and/or the staging area/fast track area) with suspected infection and tachycardia or fever will be enrolled. Study conduct will be performed under an Investigational Device Exemption (IDE) from the Food and Drug Administration (FDA). Participants in the pre-phase, treated with standard of care, will be gathered from a retrospective database using propensity matching, whereas participants in the post-phase will be managed incorporating the TriVerity™ Acute Infection and Sepsis Test results with standardized guidance for interpretation and resulting management actions. Many outcomes will be captured and compared between the pre- and post-phase phases including sepsis bundle compliance, patient disposition, appropriate use of antimicrobials (antibiotics and antivirals) and health economic findings. Safety measures for participants in the post-phase will include patient follow-up at predefined time points. The objective is to demonstrate improvement of patient management when incorporating the TriVerity Test result compared to standard of care. Improvements based on diagnostic (bacterial vs viral vs non-infectious inflammation) and prognostic (need for 7-day ICU level care) readouts of the TriVerity Test result will be tracked.
- Conditions
- Sepsis, Infections, Tachycardia, Fever
- Being tested
- TriVerity Test
- Medical subject headings
- Sepsis, Infections, Tachycardia, Fever
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TriVerity TestDiagnostic test
Participants in the post-phase of the study will have a 2.5 ml whole blood draw obtained via venipuncture into a PAXgene® Blood RNA tube. Blood samples will be processed using the TriVerity Cartridge on the Myrna Instrument located in the ED.
| Study group | Role | What they receive |
|---|---|---|
| Pre-phase standard of care | No intervention | Participants in the pre-phase, treated with standard of care, will be gathered from a retrospective database using propensity matching. |
| Post-phase TriVerity Test | Experimental | Participants in the post-phase will be managed incorporating the TriVerity Test results with standardized guidance for interpretation and resulting management actions. Receives: Diagnostic Test: TriVerity Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
SEP-1 bundle compliance
Mandatory hospital procedures for patients admitted with suspected sepsis
Measured: Within 72 hours of ED admission
Time to final ED disposition order
Time from Triage (on Day 0) to the Time the ED physician orders the subject disposition (i.e., where the subject will go next: admittance or discharge).
Measured: Date of enrollment (Day 0) to final Follow Up call (up to 35 days)
Secondary outcomes (5)
Percent of patients with antibiotics given in the ED combined with noninferior safety outcomes
Calculated based on number of patients given antibiotics in ED
Measured: Date of enrollment (Day 0) to final Follow Up call (up to 35 days)
Emergency Department LOS
Length of Stay
Measured: Date of enrollment (Day 0) to final Follow Up call (up to 35 days)
Diagnostic ordering practices
Capturing the diagnostic ordering practices of attending physician (comparing physician choices and decisions before and after the TriVerity Test)
Measured: Date of enrollment (Day 0) to 72 hours
Hospital admission rates
Overall admission rates for patients that meet study criteria from emergency department to other location (e.g., ICU)
Measured: Date of enrollment (Day 0) to 72 hours
Total hospital costs
Overall hospital costs for patients that meet study criteria
Measured: Date of enrollment (Day 0) to 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start8 Nov 2024
- Primary completion10 Mar 2026
- Study completion10 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Pre-phase is the control arm and Post-phase is the interventional arm (uses TriVerity Test intervention)
- Masking
- None (open label)
- Enrolment
- 320 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inflammatix
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06637904
- Sponsor's protocol ID
- INF-29
- Acronym
- TIMED
- Status last verified
- Feb 2025
- First submitted
- 5 Sep 2024
- Last updated
- 28 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TriVerity™ for Improved Management of Emergency Department (ED) Patients With Suspected Infections
- ClinicalTrials.gov ID
- NCT06637904
- Acronym / sponsor ID
- TIMED / INF-29
- Conditions
- Sepsis, Infections, Tachycardia, Fever
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 320 participants (actual)
- Lead sponsor
- InflammatixIndustry (pharma, biotech, devices)
- Study start
- 8 Nov 2024 (actual)
- Primary completion
- 10 Mar 2026 (actual)
- Study completion
- 10 Mar 2026 (actual)
- First posted
- 15 Oct 2024 (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.
A pre/post interventional use trial, with ED patients who are initially triaged to locations other than a dedicated patient room in the main ED (e.g., waiting room, hallway bed, and/or the staging area/fast track area) with suspected infection and tachycardia or fever will be enrolled. Study conduct will be performed under an Investigational Device Exemption (IDE) from the Food and Drug Administration (FDA). Participants in the pre-phase, treated with standard of care, will be gathered from a retrospective database using propensity matching, whereas participants in the post-phase will be managed incorporating the TriVerity™ Acute Infection and Sepsis Test results with standardized guidance for interpretation and resulting management actions. Many outcomes will be captured and compared between the pre- and post-phase phases including sepsis bundle compliance, patient disposition, appropriate use of antimicrobials (antibiotics and antivirals) and health economic findings. Safety measures for participants in the post-phase will include patient follow-up at predefined time points. The objective is to demonstrate improvement of patient management when incorporating the TriVerity Test result compared to standard of care. Improvements based on diagnostic (bacterial vs viral vs non-infectious inflammation) and prognostic (need for 7-day ICU level care) readouts of the TriVerity Test result will be tracked.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Pre-phase is the control arm and Post-phase is the interventional arm (uses TriVerity Test intervention)
| Arm | Type | Receives |
|---|---|---|
| Pre-phase standard of care | No intervention | –Participants in the pre-phase, treated with standard of care, will be gathered from a retrospective database using propensity matching. |
| Post-phase TriVerity Test | Experimental | Diagnostic Test: TriVerity TestParticipants in the post-phase will be managed incorporating the TriVerity Test results with standardized guidance for interpretation and resulting management actions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥18 years
- Participant presents to ED with ALL of the below:
- 2.1. Suspected acute infection (e.g., respiratory, urinary, abdominal, skin \& soft-tissue infection, meningitis/encephalitis, or any other infection), and 2.2. Either heart rate >100 beats per minute or/and temperature >38C. 2.3. NOT immediately roomed in a primary designated treatment location,( i.e., they can be in the waiting room, ED triage hallways, and/or ED staging area/fast track area).
- Able to provide informed consent, or consent by legally authorized representative.
- Reachable via confirmed working cell phone (with backup contact number) and willing to respond to follow-up safety checks (see below for details).
Key exclusion criteria (9 listed)
- Patient-reported treatment with systemic antibiotics, systemic antiviral agents or systemic antifungal agents within the past 7 days prior to presentation in the waiting room of the ED. Participants will not be excluded for use of:
- Patients receiving palliative or hospice care, or those receiving limited interventional care (see Appendix B).
- Prisoners, mentally disabled, or unable to give consent. Should the patient not be able to provide informed consent the legally authorized representative can provide the consent on behalf of the patient.
- Participants receiving experimental therapy or already enrolled in an interventional clinical trial in which a subject receives some type of intervention, which can include but is not limited to investigational drugs, medical devices, or vaccines. Participants that are enrolled in non-interventional or observational clinical trials will be allowed to participate in this clinical trial.
- Participants previously enrolled in the present clinical trial.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TriVerity TestParticipants in the post-phase of the study will have a 2.5 ml whole blood draw obtained via venipuncture into a PAXgene® Blood RNA tube. Blood samples will be processed using the TriVerity Cartridge on the Myrna Instrument located in the ED. | Diagnostic test | Post-phase TriVerity Test |
Primary outcome
SEP-1 bundle compliance
Time frame: Within 72 hours of ED admission
Mandatory hospital procedures for patients admitted with suspected sepsis
Time to final ED disposition order
Time frame: Date of enrollment (Day 0) to final Follow Up call (up to 35 days)
Time from Triage (on Day 0) to the Time the ED physician orders the subject disposition (i.e., where the subject will go next: admittance or discharge).
5 secondary outcomes
Percent of patients with antibiotics given in the ED combined with noninferior safety outcomes
Time frame: Date of enrollment (Day 0) to final Follow Up call (up to 35 days)
Emergency Department LOS
Time frame: Date of enrollment (Day 0) to final Follow Up call (up to 35 days)
Diagnostic ordering practices
Time frame: Date of enrollment (Day 0) to 72 hours
Hospital admission rates
Time frame: Date of enrollment (Day 0) to 72 hours
Total hospital costs
Time frame: Date of enrollment (Day 0) to 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TriVerity Test in people with Sepsis and Infections, run by Inflammatix at 2 sites in United States.
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 5 inclusion and 9 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: finished, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SEP-1 bundle compliance (time frame: Within 72 hours of ED admission). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Sep 2026; AzTrials last refreshed its copy on 8 Nov 2026.