NCT03011515已完成不适用
A Multi-center, Prospective, Validation Study to Assess the Accuracy of a Host-response Based Diagnostic for Distinguishing Between Bacterial and Viral Etiology in Adult Patients With Lower Respiratory Tract Infections
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 583
- 试验地点
- 1
- 主要终点
- To externally validate the diagnostic accuracy of a host-response based diagnostic tool called ImmunoXpert™, for differentiating between bacterial and viral etiologies in adult patients aged 18 years and older with clinical suspicion of LRTI
研究概览
简要总结
The purpose of this study is to validate the diagnostic accuracy of a novel host-response based diagnostic tool for differentiating between bacterial and viral etiologies in adult patients aged 18 years and older with clinical suspicion of lower respiratory tract infections (LRTI)
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- 是
入选标准
- •Patients aged 18 years and older who agree (or their legal guardian agree) to sign an informed consent will be eligible for inclusion.
- •The LRTI cohorts should also fulfill the following criteria:
- •Peak measured (not tactile, self-reported acceptable) temperature ≥ 37.8°C (100°F) within the last 7 days (AND)
- •Symptoms duration ≤7 days (AND)
- •Clinical suspicion of LRTI or pneumonia
排除标准
- •Oral/intravenous/intramuscular antibiotic treatment of over 48/12/12 hours' duration at time of enrollment (respectively), unless temperature ≥ 37.8°C was measured within the last 2 days
- •Another episode of an acute infection during the last 2 weeks
- •Congenital immune deficiency (CID)
- •A proven or suspected human immunodeficiency virus (HIV)-1, hepatitis B virus (HBV), or hepatitis C virus (HCV) infection
- •Active malignancy
- •Pregnancy
- •Current treatment with immune-suppressive or immune-modulating therapies including without limitations:
- •Use of high dose steroids >1 mg/kg/day prednisone or equivalent in the past two weeks
- •Monoclonal antibodies
- •Intravenous immunoglobulin (IVIG)
- •Cyclosporine, Cyclophosphamide, Tacrolimus
- •Granulocyte/Monocyte colony stimulating factor (G/GM-CSF)
- •Anti-Tumor Necrosis Factor (TNF) agents
- •Interferon (of all kinds)
- •Other severe illnesses that affect life expectancy and quality of life such as:
- •Moderate to severe psychomotor retardation
- •Post-transplant patients (including solid organs, allogeneic/autologous stem cell transplantation)
- •Moderate to severe congenital metabolic disorder
结局指标
主要结局
To externally validate the diagnostic accuracy of a host-response based diagnostic tool called ImmunoXpert™, for differentiating between bacterial and viral etiologies in adult patients aged 18 years and older with clinical suspicion of LRTI
时间窗: 0-6 days after the initiation of symptoms
次要结局
- To compare the diagnostic accuracy of ImmunoXpert™ to currently available lab measures (WBC, ANC, PCT, CRP), using sensitivity and specificity measures and predetermined cutoffs(0-6 days after the initiation of symptoms)
- To compare ImmunoXpert™ results with the physician suspected diagnosis at time of patient recruitment and compared to the reference standard diagnosis(0-6 days after the initiation of symptoms)
- To estimate the diagnostic accuracy of ImmunoXpert™ in differentiating between infectious vs non-infectious patients(0-6 days after the initiation of symptoms)
- To estimate the potential improvement in health and economic outcomes following the usage of ImmunoXpert™ compared to current practice(0-6 days after the initiation of symptoms)
研究者
研究点 (1)
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