FebriDx® Pediatric Validation Study Protocol
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 800
- 试验地点
- 17
- 主要终点
- Performance of the FebriDx® test
研究概览
简要总结
The primary objective of this study is to determine performance characteristics of the FebriDx® test in differentiating bacterial from non-bacterial etiology among febrile pediatric patients (2-11 years) presenting to the emergency department, urgent care center or primary care office with a suspected acute respiratory tract infection.
详细描述
This is a prospective, multi-center, observational, blinded study where children with suspected acute respiratory infection will undergo FebriDx® testing.
The primary outcome is the presence of a bacterial associated systemic host immune response related to a febrile acute respiratory tract infection, as compared to the reference standard of clinical adjudication as determined by a panel of pediatric experts using the Clinical Reference Algorithm that includes pathogen detection testing (e.g., bacterial culture, multiplex PCR) as well as measures of host immune response.
FebriDx is a rapid lateral flow immunoassay for the visual, qualitative, in vitro detection of elevated levels of host response proteins, Myxovirus resistance protein A (MxA) and C-reactive protein (CRP), directly from fingerstick blood.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 2 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent by parent/guardian and Assent for ages 7-11 years
- •Exhibit or report of a new onset measured temperature (oral or tympanic) of greater than or equal to 100.4°F/38°C within 3 days (72 hours) of enrollment
- •Clinical suspicion for Acute Respiratory Infection beginning within 7 days before enrollment AND presents with at least one of the following new onset of symptoms: runny nose, nasal congestion, sore throat, cough, hoarse voice, shortness of breath / difficulty breathing
排除标准
- •Unwilling to participate in 7-day follow-up or sign HIPAA waiver to obtain medical record if hospitalized
- •Immunocompromised state or taking immunosuppressive or chemotherapeutic medications in the last 30 days (e.g. oral / inhaled steroids, Methotrexate, Cyclosporine, Chemotherapy, interferon therapy)
- •Taking antibiotics or antiviral therapy in the last 14 days
- •Received a live viral immunization in the last 14 days
- •Clinical diagnosis of otitis media or recognizable viral syndrome (i.e., croup, varicella, stomatitis) at the time of enrollment
- •Prior enrollment in the study
结局指标
主要结局
Performance of the FebriDx® test
时间窗: Day 1
Positive Percent Agreement (PPA) and Negative Percent Agreement (NPA) of the FebriDx results in determining the presence of a bacterial associated systemic host immune response compared to the reference standard of clinical adjudication as determined by a panel of pediatric experts using the Clinical Reference Algorithm.
FebriDx Performance
时间窗: Single visit
Positive and negative percent agreement Presence of a bacterial associated systemic host immune response related to a febrile acute respiratory tract infection, as compared to the reference standard
次要结局
未报告次要终点