NCT04094818已完成不适用
TriVerity in the Diagnosis and Prognosis of Emergency Department Patients With Suspected Infections and Suspected Sepsis
Inflammatix26 个研究点 分布在 2 个国家目标入组 1,441 人开始时间: 2020年2月28日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,441
- 试验地点
- 26
- 主要终点
- Evaluation of the diagnostic performance of HostDx Sepsis
研究概览
简要总结
This study will analyze gene expression and other laboratory data from biological samples collected from participants with suspected respiratory, urinary, intra-abdominal, and/or skin & soft tissue infections; or suspected sepsis of any cause.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >18 year
- •Suspected acute infection (respiratory, urinary, abdominal, skin & soft-tissue), and at least one of the symptoms OR, Suspected sepsis of any cause as defined by a blood culture order by the treating physician, and at least two of the symptoms:
- •Heart rate: >90 beats/ minute
- •Temperature: >38 C or <36C
- •Respiratory Rate: >20 breaths / minutes or PaO2 of <60 mmHg or SpO2 <90%
- •Systolic blood pressure: <100 mmHg
- •Altered mental status: Per clinical exam
- •Able to provide informed consent, or consent by legally authorized representative.
排除标准
- •Participants will be ineligible for this study if they meet any of the following criteria:
- •Patient-reported treatment with systemic antibiotics, systemic antiviral agents or systemic antifungal agents within the past 7 days prior to the emergency department study visit. Participants will not be excluded for use of:
- •Antiviral treatment for HIV infection and hepatitis B and hepatitis C
- •Topical antibiotics, topical antiviral or topical antifungal agents
- •Anti-herpes prophylaxis aiding suppression of a recuring herpes infection
- •Peri-operative (prophylactic) antibiotics
- •A single dose of antimicrobials during the present ED visit (<10h before blood draw); note single dose can be considered mono or combination therapy, wherein combination is administered as part of local Standard of Care and only one dose of each medication is administered within the allowable 10-hour window
- •Patients receiving palliative or hospice care, or those receiving limited interventional care.
- •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.
- •Patients 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.
- •a. Subjects that are enrolled in non-interventional or observational clinical trials will be allowed to participate in this clinical trial.
- •Patients previously enrolled in the present clinical trial.
结局指标
主要结局
Evaluation of the diagnostic performance of HostDx Sepsis
时间窗: 28 Days After Enrollment
Concordance of HostDx Sepsis viral readout with clinical adjudication
Evaluation of the prognostic performance of HostDx Sepsis
时间窗: 7 Days After Enrollment
Concordance of HostDx Sepsis severity readout with receipt of ICU-level care (including requirement for ICU transfer, mechanical ventilation, vasopressors, or renal replacement therapy (RRT))
次要结局
- Evaluation of the prognostic performance of HostDx Sepsis for 28-Day Hospital Mortality(28 Days after enrollment)
- Evaluation of the prognostic performance of HostDx Sepsis(28 Days after enrollment)
研究者
研究点 (26)
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相关资讯
Inflammatix Publishes Breakthrough Sepsis Research in Nature Medicine, Validates AI-Powered TriVerity Test- Inflammatix published three landmark studies in Nature Medicine that redefine sepsis diagnosis and treatment through AI-powered immune profiling and consensus frameworks.
- The SEPSIS-SHIELD study validated TriVerity's ability to distinguish bacterial from viral infections and predict illness severity in over 1,200 patients with high sensitivity and specificity.
- Two new consensus frameworks, HI-DEF and CTS, identified distinct immunological states in sepsis patients, with dysregulated patients showing 5-7 times higher mortality risk.
- TriVerity received FDA 510(k) clearance in January 2025 and delivers results in 30 minutes to guide emergency department triage decisions.11 months agoInflammatix's TriVerity Test Receives FDA Clearance for Rapid Sepsis and Infection Assessment- Inflammatix's TriVerity test system has received FDA clearance for emergency triage of patients with suspected acute infection or sepsis, providing rapid results.
- The test identifies bacterial and viral infections and evaluates the risk of developing severe illness by measuring the expression of 29 genes.
- Clinical studies involving 1,222 patients demonstrated high accuracy in predicting patient outcomes, with AUC scores ranging from 0.77-0.91.
- TriVerity aims to improve outcomes, survival rates, and healthcare utilization by offering a precise measure of infection likelihood and risk stratification.last year