Clinical Evaluation of the Xpert® Tropical Fever Test on the GeneXpert® Edge System Using Venous and Capillary Whole Blood Specimens
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- Cepheid
- 入组人数
- 2,500
- 试验地点
- 1
- 主要终点
- Clinical performance [PPA and NPA] of Xpert Tropical Fever
研究概览
简要总结
This is a multi-site, observational, cross-sectional clinical study that includes geographically diverse sites within and outside the United States.
详细描述
Capillary and venous whole blood specimens will be prospectively collected from consented individuals who present with acute febrile illness and clinical suspicion of infection with fever-causing agents
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 14 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Presents with AFI as defined for endemic populations or fever as defined in non-endemic populations or presents with fever as defined for nonendemic populations
- •Clinical suspicion of disease caused by at least one of the following: Plasmodium spp, dengue virus, Zika virus, chikungunya virus, or Leptospira (endemic population)
- •History of residence in or travel to an endemic geographic region within 3 months prior to specimen collection (endemic population)
排除标准
- •Self-reported or known antibiotic or antimalarial use (oral or intravenous) within 3 days prior to enrollment (endemic and nonendemic population)
- •History of residence in or trael to endemic geographic region as defined by protocol ≤ three months prior to specimen collection (nonendemic population)
- •Clinical suspicion of infection caused by any of the following: Plasmodium spp., dengue virus, Zika virus, chikungunya virus, or Leptospira spp. (nonendemic population)
研究组 & 干预措施
Capillary and venous WB specimens
WB specimens collected from individuals who present with AFI and have clinical suspicion of infection caused by at least one fever-causing agent
干预措施: Xpert Tropical Fever test (Diagnostic Test)
结局指标
主要结局
Clinical performance [PPA and NPA] of Xpert Tropical Fever
时间窗: Clinical performance on specimens collected at Baseline (Day 0)
Evaluating the PPA and NPA of Xpert Tropical Fever relative to the comparator(s)
次要结局
未报告次要终点