NCT03364257Unknown不适用
National, Single-arm Clinical Study on iDTECT™ Blood Performance to Identify Viral or Bacterial Pathogens in Febrile Neutropenic Patients With Suspected Infection
适应症
试验速览
- 阶段
- 不适用
- 发起方
- Pathoquest
- 入组人数
- 97
- 试验地点
- 5
- 主要终点
- Rate of detection of clinically relevant bacterial or viral pathogen (CRBV) by iDTECT™ Blood as compared to conventional microbiological methods at inclusion
研究概览
简要总结
Prospective, multicentre French observational study assessing the performance and medico-economic utility of iDTECT Blood versus conventional microbiologic diagnosis in patients with febrile neutropenia
详细描述
Febrile neutropenic patients suspected of sepsis will follow the conventional infectious diagnosis work-up over the entire observation period, and will be tested in addition with iDTECT Blood on Study Day 1.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 5 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 5 years and weight > 16 Kg
- •Patients having signed the written study informed consent form (ICF) prior to any study-mandated procedure. For children/adolescents: ICF obtained from both children's parents/ legal representative prior to any study-mandated procedure, and in addition for adolescents (13-17 years): assent form to be signed
- •Patient presenting severe neutropenia (absolute neutrophil count < 0.5 Giga/L) anticipated to be long lasting (> 10 days) following intensive chemotherapy for acute myeloid or lymphoid leukaemia (AML or ALL) or myelodysplastic syndrome or in the context of hematopoietic stem cells transplantation
- •Febrile episode (oral temperature > 38.3°C once, or 2 measures > 38.0°C taken 2h apart).
排除标准
- •Known HIV infection or AIDS diagnosis
- •Already microbiologically confirmed infection
- •Patient status preventing the study test to be performed
- •Patient with an obvious infectious disease diagnosis requiring minimal additional microbiological documentation or confirmation
结局指标
主要结局
Rate of detection of clinically relevant bacterial or viral pathogen (CRBV) by iDTECT™ Blood as compared to conventional microbiological methods at inclusion
时间窗: 7 months
Sensitivity, specificity, negative predictive value, positive predictive value at inclusion
次要结局
- Antiobiotic use(9 months)
研究者
研究点 (5)
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