TriVerity Test for Infections

(TIMED Trial)

Recruiting in Palo Alto (17 mi)

+1 other location

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Inflammatix

Must not be taking: Systemic antibiotics, systemic antivirals

Disqualifiers: Palliative care, Prisoners, others

No Placebo Group

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the TriVerity Test treatment for infections?

The research highlights the need for better tools to identify and treat sepsis early, which suggests that the TriVerity Test could be valuable if it helps in early recognition and treatment of sepsis, potentially improving patient outcomes. ^{1 2 3 4 5}

How does the TriVerity Test for Infections differ from other treatments for infections?

The TriVerity Test for Infections is unique because it likely involves a rapid diagnostic approach, similar to the SeptiFast system, which allows for quicker identification of pathogens compared to traditional methods that take several days. This rapid detection can lead to earlier and more appropriate treatment of infections, especially in critical conditions like sepsis. ^{6 7 8 9 10}

Research Team

Eligibility Criteria

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

I am 18 years old or older.

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.

Exclusion Criteria

Participants previously enrolled in the present clinical trial.

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

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.

Trial Timeline

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

Treatment Details

Interventions

• TriVerity Test (Diagnostic 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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

References

1. United States 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. [2012]

2. England pubmed.ncbi.nlm.nih.gov

Mechanisms of sepsis and insights from clinical trials. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Clinical and economic impact of a quality improvement initiative to enhance early recognition and treatment of sepsis. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

Outcome measures for clinical research in sepsis: a report of the 2nd Cambridge Colloquium of the International Sepsis Forum. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Septic shock without documented infection: an uncommon entity with a high mortality. [2019]

6. England 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. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Diagnostic utility of LightCycler SeptiFast and procalcitonin assays in the diagnosis of bloodstream infection in immunocompromised patients. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Tricuspid Annular Plane of Systolic Excursion (TAPSE) for the Evaluation of Patients with Severe Sepsis and Septic Shock. [2020]

9. Spain 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. [2019]

10. Korea (South) 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. [2018]