NCT02511262已完成不适用
Clinical Trial Protocol for the Illumigene® Mycoplasma Direct Assay
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 471
- 试验地点
- 3
- 主要终点
- Qualitative detection of Mycoplasma Pneumoniae to aid in the diagnosis of M. pneumoniae infections.
研究概览
简要总结
The objective of this Clinical Trial is to define the methods to be used to document that illumigene® Mycoplasma Direct meets its intended use claims, using the illumipro instrument, with throat swab samples collected from symptomatic patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The subject has willingly given written informed consent.
- •Specimens provided from subjects with symptoms of upper respiratory infections which may be attributable to Mycoplasma pneumoniae, or from patients suspected of having Mycoplasma pneumoniae.
- •Dual throat swab collected per subject.
排除标准
- •Subjects who are unwilling to sign the written informed consent.
- •Multiple sets of specimens collected from the same subject.
- •Subjects who are unwilling or unable to provide the required number of throat swabs.
结局指标
主要结局
Qualitative detection of Mycoplasma Pneumoniae to aid in the diagnosis of M. pneumoniae infections.
时间窗: Up to 14 days
Testing of each enrolled subject's samples will be performed within 14 days of collection.
次要结局
未报告次要终点
研究者
研究点 (3)
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