Diagnostic Modalities for Severe Odontogenic Infections Using Rapid, Target Enriched Multiplex PCR (TEM- PCR)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Specificity as assessed by number of participants who had matching results between TEM-PCR and standard microbial culture
研究概览
简要总结
The purpose of the study is to evaluate the sensitivity and specificity of the Target Enriched Multiplex (TEM) polymerase chain reaction (PCR) platform for the rapid molecular diagnosis and treatment of odontogenic deep space neck infections.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients in whom there is clinical and radiographic evidence of an odontogenic deep space neck infection.
排除标准
- •Patients with gross communication between the abscess and the oral cavity will be excluded.
研究组 & 干预措施
Subjects with advanced deep space odontogenic infection
Subjects will be diagnosed via two methods: 1. Target Enriched Multiplex PCR (TEM- PCR) and 2. Standard microbial culture.
干预措施: Target Enriched Multiplex PCR (TEM- PCR) (Diagnostic Test)
Subjects with advanced deep space odontogenic infection
Subjects will be diagnosed via two methods: 1. Target Enriched Multiplex PCR (TEM- PCR) and 2. Standard microbial culture.
干预措施: Microbial culture (Diagnostic Test)
结局指标
主要结局
Specificity as assessed by number of participants who had matching results between TEM-PCR and standard microbial culture
时间窗: Baseline (at the time the sample was obtained from the patient)
次要结局
未报告次要终点
研究者
Nagi Demian
Clinical Assistant Professor
The University of Texas Health Science Center, Houston