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TriVerity Test for Infections (TIMED Trial)
N/A
Recruiting
Research Sponsored by Inflammatix
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age ≥18 years
Be older than 18 years old
Must not have
Patients receiving palliative or hospice care, or those receiving limited interventional care.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within 72 hours of ed admission
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to enroll emergency department patients with suspected infection and rapid heart rate or fever who are initially placed in areas like waiting rooms or hallways. The study will compare patients treated with standard care before
Who is the study for?
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).
What is being tested?
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.
What are the potential side effects?
Since this trial involves diagnostic testing rather than medication or invasive procedures, direct side effects from the intervention itself are not anticipated.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am currently receiving care focused on relieving symptoms rather than curing my disease.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ within 72 hours of ed admission
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within 72 hours of ed admission
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
SEP-1 bundle compliance
Time to final ED disposition order
Secondary study objectives
Diagnostic ordering practices
Emergency Department LOS
Hospital admission rates
+2 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Post-phase TriVerity TestExperimental Treatment1 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 careActive Control1 Intervention
Participants in the pre-phase, treated with standard of care, will be gathered from a retrospective database using propensity matching.
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Who is running the clinical trial?
InflammatixLead Sponsor
5 Previous Clinical Trials
2,232 Total Patients Enrolled