Pilot Study of Strepic® Device for the Diagnosis of Group A Streptococcal Pharyngitis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 426
- 试验地点
- 1
- 主要终点
- Strepic Device Image
研究概览
简要总结
The objective of this pilot study is to acquire images using the Strepic® device, a clinical prototype that has been designed specifically as a viable, low-cost, commercially realizable autofluorescence-based diagnostic test, using (1) fluorescence and (2) white light image data, as well as other clinical data points. By acquiring and analyzing the images of pharyngeal bacterial fluorescence and white light patterns in patients with Group A Streptococcus (GAS)-associated pharyngitis and comparing them with those observed in non-GAS pharyngitis, it is believed an algorithm can be developed such that the device will improve the ability of clinicians to quickly and accurately identify GAS infections.
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
- 7 Years 至 64 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients aged 7-64 years of age with suspected GAS pharyngitis with modified Centor (McIsaac) score ≥2; and
- •Patient agrees to participate in study and patient or parent/guardian sign consent/assent form.
排除标准
- •Pharyngeal swab performed immediately prior to study team approach;
- •Prior enrollment in this study;
- •Pharyngeal symptoms >7 days;
- •Peritonsillar abscess;
- •Antibiotic use within one week of index visit;
- •Inability to open mouth to visualize the pharynx; and
- •Inability to understand English or Spanish, as study forms including consent and assent forms will be written in English and Spanish;
- •Woman who is pregnant (self-reported, pregnancy test will not be performed) or nursing;
- •Current prisoner (define as an individual involuntarily confined in a penal institution, including persons: (1) sentenced under a criminal or civil statue; (2) detained pending arraignment, trial, or sentencing; and (3) detained in other facilities (e.g., for drug detoxification or treatment of alcoholism) under statutes or commitment procedures providing such alternatives to criminal prosecution or incarceration in a penal institution).
结局指标
主要结局
Strepic Device Image
时间窗: Day 1
A picture of the participant's throat will be obtained at enrollment.
Throat culture or PCR result
时间窗: Day 2
The results of throat culture or PCR (depending on the site) will be recorded and compared to the Strepic Device image findings
次要结局
未报告次要终点
研究者
David A. Talan
Co-PI
Olive View-UCLA Education & Research Institute