CLP-0019- FebriDx® Method Comparison Study Protocol
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 800
- 试验地点
- 7
- 主要终点
- Performance
研究概览
简要总结
The goal of this observational study is to learn about the performance and ease of use of FebriDx when operated by persons without laboratory experience or training in patients with acute respiratory symptoms. The main question it aims to answer is:
• Is FebriDx accurate at differentiating bacterial from non-bacterial respiratory infections when used by untrained operators? Trained and untrained participants will run the FebriDx test on patients with respiratory symptoms to evaluate comparability.
详细描述
A prospective, multi-center, blinded observational study to demonstrate that the FebriDx test meets the CLIA statutory criteria for waiver by providing sufficient assurance that the addition of a new operator population (untrained) and environment of use (waived) will not adversely impact the performance or safety of the test.
The study aims to:
- Demonstrate that FebriDx® Test is accurate and the operator can perform the test with a negligible risk of erroneous result.
- As a secondary objective, ease-of-use objective data and subjective feedback relating to the device and its operator interface will be collected at the end of the study and assessed for comparability.
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
- 12 Years 至 64 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject exhibits or reports a new onset measured temperature (oral or tympanic) of greater than or equal to 100.5°F/38°C within 3 days (72 hours) of enrollment or at the visit
- •Subject has clinical suspicion for Acute Respiratory Infection and presents with at least one (1) of the following new onset symptoms beginning ≤ 7 days of enrollment: runny nose, nasal congestion, sore throat, cough, hoarse voice or shortness of breath
排除标准
- •Subject is unable or unwilling to provide signed, Informed Consent
- •Subject is less than 12 years old or over 64 years old
- •Subject has a fever that started more than 3 days (> 72 hours) prior to enrollment
- •Subject has symptoms of Acute Respiratory Infection that started > 7 days of enrollment
- •Subject is receiving interferon therapy (e.g. MS, HIV, HBV, HCV) in the last 30 days
- •Subject is in an immunocompromised state (e.g. HIV) or taking immunosuppressive or chemotherapeutic medications in the last 30 days (e.g. oral steroids, Methotrexate, Cyclosporine, Antimetabolite chemotherapy, interferon therapy)
- •Subject has taken antibiotics or antiviral therapy in the last 14 days
- •Subject received a live viral immunization in the last 14 days
- •Subject has significant trauma or burns (> 5% total body surface area or full thickness (3rd°)) in the last 30 days
- •Subject has had major surgery (requiring intravenous anesthesia and/or respiratory assistance) in the last 30 days
- •Subject has a history of a myocardial infarction or stroke in the last 30 days
结局指标
主要结局
Performance
时间窗: Day 1
Positive Percent Agreement (PPA), Negative Percent Agreement (NPA) and 95% confidence intervals will be calculated for each untrained operator and compared to performance in trained operators (truth).
次要结局
- Usability(Day 1)