Multi-Center Study of a Point-of-Care Immunoassay for the Detection of Bacterial Sinusitis
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 800
- 试验地点
- 7
- 主要终点
- Sensitivity (positive predictive agreement) and specificity (negative predictive agreement) of the diagnostic device
研究概览
简要总结
This study is conducted to evaluate the performance of a rapid, point-of-care in vitro diagnostic device (Sinu-Test®) for the qualitative detection of the three most common pathogens responsible for causing bacterial sinusitis.
详细描述
Mucous specimens will be collected from patients displaying symptoms of acute bacterial sinusitis enrolled by primary care and/or otolaryngology clinics in the United States. Health care professionals not having endoscopy certification will collect specimens using the Entvantage sample collection device. Health care professionals with nasal endoscopy certification or specialty training will collect comparator specimens using an endoscope. Untrained operators with a range of education and training (primary care physician, otolaryngologist, physician assistant, nurse practitioner, registered nurse or other healthcare professional), will perform the Sinu-Test® lateral flow assay in an outpatient setting. Mucous samples will be tested for the presence of 3 bacterial pathogens responsible for sinusitis using the Sinu-Test® in the clinic and by a composite comparator method comprised of standard quantitative bacterial culture with identification (matrix-assisted laser desorption/ionization-Time of Flight (MALDI-TOF) mass spectrometry instrument) and semiquantitative real-time polymerase chain reaction (real-time PCR) of the residual culture sample and the Sinu-Test® residual swab performed by a central laboratory.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
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
- •Meets definition of acute sinusitis by Infectious Disease Society of America (2012)
排除标准
- •Chronic sinusitis
- •Cystic fibrosis
- •Patients treated with antibiotics currently or within the previous 30 days.
- •Subjects with a prior history of sinus surgery will be excluded due to the modification of sinonasal anatomy.
- •Primary immunodeficiencies, as self-reported
- •Combined variable immunodeficiency
- •Immunodeficiency with reduced immunoglobulin G (IgG) and immunoglobulin A (IgA)-bearing cells
- •Kartagener Syndrome (ciliary dyskinesia)
- •Agammaglobulinemia
- •Sickle cell disease
- •Acquired immunodeficiencies, as self-reported
- •Chemotherapy
- •Radiation therapy
- •Transplantation
- •Poorly controlled Diabetes mellitus
- •Cognitive impairment resulting in the inability to provide informed consent.
- •Special groups, such as children under the age of 18, and men and women who are in prison will not participate in this study.
结局指标
主要结局
Sensitivity (positive predictive agreement) and specificity (negative predictive agreement) of the diagnostic device
时间窗: Cumulation of one-time subject sample results obtained in 20-30 minutes for point-of-care test and 3-5 days for lab results
Assessment of the true positive and true negative rate of the point-of-care test device relative to the composite reference standard for each of the 3 bacterial microorganisms.
次要结局
- Positive predictive value (PPV) and negative predictive value (NPV)(Cumulation of one-time subject sample results obtained in 20-30 minutes for point-of-care test and 3-5 days for lab results)
- Positive likelihood ratio (LR+) and negative likelihood ratio (LR-)(Cumulation of one-time subject sample results obtained in 20-30 minutes for point-of-care test and 3-5 days for lab results)