TriVerity Test for Infections

(TIMED Trial)

Recruiting at 1 trial location

Overseen By Shailee Rasania

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Inflammatix

Must not be taking: Systemic antibiotics, systemic antivirals

Disqualifiers: Palliative care, Prisoners, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

300 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve infection management in emergency department (ED) settings. It compares current standard care with a new test called the TriVerity Test, which helps doctors determine if an infection is bacterial, viral, or non-infectious. The trial seeks participants who arrive at the ED with a suspected infection and either a fast heart rate or fever but are not immediately placed in a designated treatment room. The goal is to demonstrate that the TriVerity Test leads to better treatment decisions and outcomes for patients. As an unphased trial, this study allows participants to contribute to innovative research that could enhance infection management in emergency settings.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you've taken systemic antibiotics, antivirals, or antifungals in the past 7 days. However, ongoing treatments for chronic viral infections like HIV or hepatitis are allowed.

What prior data suggests that the TriVerity Test is safe for patients with suspected infection and tachycardia or fever?

Research has shown that the TriVerity Test is generally safe. Studies have found that this test helps doctors determine the type and severity of an infection, aiding in treatment decisions during emergencies.

No direct evidence of safety problems or negative effects has been reported in the reviewed studies. The trial has special permission from the FDA, indicating that the TriVerity Test meets certain safety standards for testing in people.

Overall, research suggests that the TriVerity Test is well-tolerated, with no major safety concerns identified. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the TriVerity Test because it offers a new way to manage infections by using test results to guide treatment decisions more effectively. Unlike standard treatments that rely heavily on broad-spectrum antibiotics and generalized protocols, the TriVerity Test provides specific insights into the infection type, allowing for tailored treatment plans. This targeted approach can lead to more precise management, potentially reducing the misuse of antibiotics and improving patient outcomes. By integrating test results into treatment decisions, this method could revolutionize how infections are diagnosed and treated.

What evidence suggests that the TriVerity Test is effective for managing infections?

Research has shown that the TriVerity Test effectively diagnoses infections caused by bacteria or viruses. Studies have found that it performs well even in individuals with weakened immune systems. The test quickly assesses the body's response to an infection, aiding doctors in determining if a patient requires more intensive care. In this trial, participants in the post-phase will be managed by incorporating TriVerity Test results with standardized guidance for interpretation and resulting management actions. In a study involving over 1,200 patients, the test accurately identified those needing critical care. This suggests that TriVerity could enhance infection management in emergency situations. ^{1 3 6 7 8}

Are You a Good Fit for This Trial?

This trial is for adults over 18 with suspected infections who are not immediately placed in a primary treatment area of the ED. They must be able to give consent and have a working phone for follow-up checks. Participants should either have a rapid heartbeat (>100 bpm) or fever (>38C).

Inclusion Criteria

Able to provide informed consent, or consent by legally authorized representative.

I came to the ER with a possible infection and either a fast heart rate or high fever, and I'm not in the main treatment area yet.

I have a working cell phone and will respond to safety check calls.

Exclusion Criteria

Participants previously enrolled in the present clinical trial.

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.

I am able to give consent or have someone who can legally consent for me.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Pre-phase Standard of Care

Participants in the pre-phase are treated with standard of care, gathered from a retrospective database using propensity matching

Retrospective

Post-phase TriVerity Test

Participants in the post-phase are managed incorporating the TriVerity Test results with standardized guidance for interpretation and resulting management actions

Up to 35 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 35 days

What Are the Treatments Tested in This Trial?

Interventions

• TriVerity Test

Trial Overview The TriVerity Test, an investigational device, is being tested to see if it can improve management of ED patients with suspected infections. The study compares outcomes before and after implementing the test results into patient care.

How Is the Trial Designed?

Group I: Post-phase TriVerity Test Experimental Treatment 1 Intervention

Participants in the post-phase will be managed incorporating the TriVerity Test results with standardized guidance for interpretation and resulting management actions.

Group II: Pre-phase standard of care Active Control 1 Intervention

Participants in the pre-phase, treated with standard of care, will be gathered from a retrospective database using propensity matching.

Who Is Running the Clinical Trial?

Inflammatix

Lead Sponsor

Trials

6

Recruited

2,500+

Published Research Related to This Trial

A quality improvement initiative for sepsis management, including an electronic screening tool and a First-Dose STAT Antibiotic policy, led to significant reductions in ICU length of stay (from 5.85 to 4.21 days) and overall treatment costs (from $14,378 to $12,311) for patients with sepsis.

While there were nonsignificant decreases in overall length of stay and in-hospital mortality, the initiative effectively improved early recognition and treatment of sepsis, as indicated by a decrease in the percentage of patients with the highest disease-severity coding from 7.9% to 0%.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical and economic impact of a quality improvement initiative to enhance early recognition and treatment of sepsis. Judd, WR., Stephens, DM., Kennedy, CA.[2018]

In a pilot study of 24 patients with severe sepsis or septic shock, the measurement of tricuspid annular plane of systolic excursion (TAPSE) did not show a significant correlation with ICU admission rates or mortality, suggesting that TAPSE may not be a reliable indicator in this context.

The study highlights the need for larger trials to further investigate the potential role of TAPSE in evaluating septic cardiomyopathy, as the current findings may be influenced by patient comorbidities and the strict definitions of sepsis used.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tricuspid Annular Plane of Systolic Excursion (TAPSE) for the Evaluation of Patients with Severe Sepsis and Septic Shock. Lahham, S., Lee, C., Ali, Q., et al.[2020]

In a study of 227 patients treated for septic shock in an ICU, 87% had a clinically identified source of infection, highlighting the importance of identifying infections in septic patients.

Patients with septic shock but without a clinically identified infection had a significantly higher ICU mortality rate (86%) compared to those with an identified infection (66%), indicating that lack of an identifiable infection is associated with worse outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Septic shock without documented infection: an uncommon entity with a high mortality. Reyes, WJ., Brimioulle, S., Vincent, JL.[2019]

A comprehensive reevaluation of outcome measures in sepsis clinical trials is necessary to better assess the effectiveness of new therapies, focusing on both biological activity and patient-centered benefits.

The proposed approach emphasizes the importance of using composite measures that integrate both morbidity and mortality, particularly for populations like children, to provide meaningful insights into therapeutic efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcome measures for clinical research in sepsis: a report of the 2nd Cambridge Colloquium of the International Sepsis Forum. Marshall, JC., Vincent, JL., Guyatt, G., et al.[2022]

The SeptiFast system demonstrated a higher detection rate of pathogens (11.3%) compared to traditional blood culture methods (8.0%) in a study of 212 patients suspected of sepsis, indicating its potential for faster diagnosis.

In patients who had already received antibiotics, SeptiFast was less affected by prior treatment and detected more pathogens than blood cultures, suggesting it could be crucial for timely and effective treatment in these cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of pathogen detection from clinical samples by real-time polymerase chain reaction using a sepsis pathogen DNA detection kit. Yanagihara, K., Kitagawa, Y., Tomonaga, M., et al.[2022]

Clinical trials aimed at treating sepsis and septic shock have shown limited success, often only benefiting patients with severe illness while potentially harming those with milder cases.

There is a critical need for better methods to assess illness severity and identify biomarkers that can help pinpoint high-risk patients for more effective treatment strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mechanisms of sepsis and insights from clinical trials. Seam, N., Suffredini, AF.[2021]

The differential time to positivity (DTP) method for diagnosing catheter-related bloodstream infections (CR-BSI) showed an 80% sensitivity and 99% specificity in a study of 226 critically ill patients, indicating it is a reliable diagnostic tool.

Using the DTP method can help avoid unnecessary catheter removals, as it accurately identifies CR-BSI cases based on the timing of blood culture positivity, with a suggested cut-off of 17.7 hours for hub blood cultures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Differential time to positivity of blood cultures: a valid method for diagnosing catheter-related bloodstream infections in the intensive care unit. García, X., Sabatier, C., Ferrer, R., et al.[2019]

A new rapid method for identifying bacteria and testing their antibiotic susceptibility from positive blood cultures can provide results within six hours, significantly faster than conventional methods.

In a study of 254 samples, this method achieved high accuracy with 82.3% and 78.3% correct species identification rates using two different rapid ID systems, and a 97.8% concordance rate for antibiotic susceptibility testing compared to traditional methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Same-Day Identification and Antimicrobial Susceptibility Testing of Bacteria in Positive Blood Culture Broths Using Short-Term Incubation on Solid Medium with the MicroFlex LT, Vitek-MS, and Vitek2 Systems. Ha, J., Hong, SK., Han, GH., et al.[2018]

In a study of 48 septic patients in the ICU, measuring the time-to-positivity (Tpos1) of antibiotic efficacy 24 hours after treatment initiation was linked to shorter ICU and hospital stays, suggesting it could be a useful marker for antibiotic activity.

Patients with adequate Tpos1 had a median ICU stay of 7.8 days compared to 14.4 days for those with inadequate Tpos1, indicating that early antibiotic effectiveness may influence recovery time, although it did not correlate with 28-day survival rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pilot clinical trial to evaluate a novel time-to-positivity assay to measure the effectiveness of antibiotic therapy for septic patients in intensive care. Jerwood, S., Hankins, M., Cohen, J.[2012]

Procalcitonin (PCT) levels correlate with sepsis in immunocompromised patients but are not reliable enough to be used alone for diagnosis.

The SeptiFast (SF) test, when used alongside blood cultures, enhances the detection of pathogens in immunocompromised patients, particularly those who have received prior antibiotic treatment or have invasive fungal infections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diagnostic utility of LightCycler SeptiFast and procalcitonin assays in the diagnosis of bloodstream infection in immunocompromised patients. Mauro, MV., Cavalcanti, P., Perugini, D., et al.[2019]

Citations

1. nature.com nature.com/articles/s41591-025-03933-y

Clinical validation of an AI-based blood testing device for ... To validate TriVerity, the SEPSIS-SHIELD study enrolled 1,222 patients with clinically adjudicated infection status and need for critical care ...

2. inflammatix.com inflammatix.com/inflammatix-presents-triverity-data-at-acep24/

Inflammatix Presents Data at ACEP24 Showing High ... Our data show that TriVerity yields diagnostic and prognostic results with a high degree of accuracy, regardless of the patient's immune status.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11845329/

Early sepsis recognition: a pilot study using a rapid high ... Our results demonstrated that TriVerity exhibited high accuracy in diagnosing both bacterial and viral infections. The performance of TriVerity ...

4. journals.asm.org journals.asm.org/doi/10.1128/jcm.00352-25

Analytical evaluation of TriVerity, a rapid diagnostic and ... We evaluated the analytical performance of the TriVerity test system, a benchtop system for rapid measurement and interpretation of host ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT04094818

Study Details | NCT04094818 | TriVerity in the Diagnosis ... This study will analyze gene expression and other laboratory data from biological samples collected from participants with suspected respiratory, urinary, ...

6. inflammatix.com inflammatix.com/triverity/

Triverity Act early on acute infections with the TriVerity Test. Identify infection type, assess severity, and support treatment decisions in emergency care.

7. prnewswire.com prnewswire.com/news-releases/inflammatix-announces-three-landmark-publications-in-nature-medicine-that-redefine-acute-infection-and-sepsis-diagnosis-and-treatment-302570766.html

Inflammatix Announces Three Landmark Publications in ... TriVerity shows the likelihood of a bacterial infection, a viral infection, and illness severity in adult patients with suspected acute ...

8. veranex.com veranex.com/inflammatix

Inflammatix Pictured is the TriVerity™ Acute Infection and Sepsis Test system which includes the Myrna™ Instrument and the TriVerity cartridge.