NCT00736567已完成不适用
Evaluation of a Diagnostic Enteric Card for Management of Diarrhea in a Clinical Site in Fortaleza, Brazil
PATH1 个研究点 分布在 1 个国家目标入组 436 人开始时间: 2008年5月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 436
- 试验地点
- 1
研究概览
简要总结
PATH is a member of a consortium that is developing a Diagnostic Enterics Card (DEC) which will allow clinicians to diagnose a group of diarrheagenic pathogens linked to morbidity and mortality. The pathogens detected on DEC include Salmonella, Campylobacter jejuni, Shigella species, and Escherichia coli O157:H7. This study will evaluate the performance of the assays and the platform in clinical conditions with non-expert users. It will provide important data on the performance of DEC for at least one target pathogen, an understanding of the potential impact of different sample types on device performance, and human factors associated with instrument interface in the field.
研究设计
- 研究类型
- Observational
- 时间视角
- Cross Sectional
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have 3 or greater liquid stools in the past 24 hours.
- •Provide written informed consent from at least one parent in the case of children under 18 years of age.
- •Provide written informed consent for those participants above 18 years of age.
- •Provide assent in the case of children 10 years of age or greater.
排除标准
- •Previously enrolled in the study.
- •Parents are unwilling or unable to provide written informed consent.
- •Report using antibiotics in the last 30 days.
- •Adolescent (<18 years old) parent of a child already enrolled in the study.
研究者
研究点 (1)
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