A Prospective Multi-Centre Study of the Performance of Ellume·Lab Group A Strep Test Versus Culture for the Rapid Detection of Group A Streptococcus in Participants With Acute Pharyngitis
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 8
- 主要终点
- The sensitivity of the ellume·lab Group A Strep Test in detecting Group A Streptococcus in samples collected using a throat swab as compared to bacterial culture
研究概览
简要总结
Participants who meet the eligibility criteria and who consent to participation or whose parents/legal guardian consent to their participation, will be enrolled in the study for a period of up to 14 days. Enrolment visit (Day 1) assessments for all participants will include the collection of throat swabs, testing by staff at the site using the ellume·lab Group A Strep Test and testing for Group A Streptococcus by a central laboratory using bacterial culture and polymerase chain reaction (PCR). All participants will be followed up with a phone assessment of adverse events between Days 2-14.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 3 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female participants aged 3 years of age or older
- •Must currently be presenting with symptoms characteristic of pharyngitis, possibly Group A Strep, including:
- •Acute onset of sore throat;
- •Fever ≥ 37.8° C (100° F) at presentation or history or parent/guardian-reported history of fever ≥ 37.8° C or feeling feverish within 24 hours of presentation and;
- •At least one of the following:
- •Red and swollen/inflamed tonsils (or fossae);
- •Pharyngeal or tonsillar exudate; o Cervical lymphadenopathy
- •≤ 14 days from onset of signs and symptoms of pharyngitis
- •Parent/legal guardian of Participants < 18 years of age capable and willing to give informed consent
- •Participants ≥18 years of age capable and willing to give informed consent
排除标准
- •Participants < 3 years of age
- •Participants undergoing treatment with antibiotics, or those who have undergone treatment with antibiotics for current episode of pharyngitis
- •Currently enrolled in another clinical trial or used any investigational device within 30 days preceding informed consent
- •Participants 18 years of age or older unable to understand English and consent to participation
- •Parent/legal guardian of Participants < 18 years of age unable to understand English and consent to participation of child
- •Prior enrollment in this clinical validation study
研究组 & 干预措施
ellume·lab Group A Streptococcus Test
ellume·lab Group A Streptococcus Test
Pharyngeal samples from participants will be tested with:
ellume.lab Group A Streptococcus Test; Polymerase Chain Reaction (PCR) and bacterial culture.
干预措施: ellume·lab Group A Streptococcus Test (Diagnostic Test)
ellume·lab Group A Streptococcus Test
ellume·lab Group A Streptococcus Test
Pharyngeal samples from participants will be tested with:
ellume.lab Group A Streptococcus Test; Polymerase Chain Reaction (PCR) and bacterial culture.
干预措施: Bacterial Culture (Diagnostic Test)
ellume·lab Group A Streptococcus Test
ellume·lab Group A Streptococcus Test
Pharyngeal samples from participants will be tested with:
ellume.lab Group A Streptococcus Test; Polymerase Chain Reaction (PCR) and bacterial culture.
干预措施: Polymerase Chain Reaction (PCR) (Diagnostic Test)
结局指标
主要结局
The sensitivity of the ellume·lab Group A Strep Test in detecting Group A Streptococcus in samples collected using a throat swab as compared to bacterial culture
时间窗: 1 Week
Establish sensitivity against a gold standard. Report as a percentage of participants with 96% confidence intervals
The specificity of the ellume·lab Group A Strep Test in detecting Group A Streptococcus in samples collected using a throat swab as compared to bacterial culture
时间窗: 1 Week
Establish specificity against a gold standard. Report as a percentage of participants with 96% confidence intervals
次要结局
- The sensitivity of the ellume·lab Group A Strep Test in detecting Group A Streptococcus in samples collected using a throat swab as compared to PCR(1 Week)
- The specificity of the ellume·lab Group A Strep Test in detecting Group A Streptococcus in samples collected using a throat swab as compared to PCR(1 Week)
- Ease of use as assessed by operator questionnaire(1 Week)