NCT03299608招募中不适用
Exhaled Breath Analysis for Rapid Diagnosis in Opportunistic Respiratory Infections in Hematological Patients
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 246
- 试验地点
- 1
- 主要终点
- Diagnostic accuracy
研究概览
简要总结
To quantify the diagnostic, prognostic and therapeutic value of spectrometric analysis of exhaled breath from hematological patients with respiratory infection.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18y at start of study
- •One of the following diagnoses:
- •De novo, refractory or relapsed AML/MDS receiving intensive chemotherapy
- •De novo, refractory or relapsed ALL/T-lymphoblastic lymphoma receiving intensive chemotherapy
- •Aplastic anemia requiring ATG therapy
- •Any patient admitted for either autologous hematopoietic stem cell transplantation. Transplantation may not have been performed at time of enrolment.
- •Any patient admitted with allogeneic hematopoietic stem cell transplantation within the last year, or planned during this admission.
- •Written informed consent obtained from the patient
排除标准
- •Hematological disease beyond the specified inclusion criteria
- •Signs of active respiratory infection
- •If previously enrolled: incomplete clearance of all signs of respiratory infection (both clinically, microbiologically and radiologically).
结局指标
主要结局
Diagnostic accuracy
时间窗: Through study completion (i.e. 6 weeks after diagnosis)
Accuracy (expressed as specificity/sensitivity/NPV/PPV) will be assessed as compared to the revised EORTC-MSG criteria, at moment of diagnosis by high-resolution CT and bronchoscopy
次要结局
- Diagnostic accuracy at 2 weeks as compared to the revised EORTC-MSG response criteria using high-resolution CT(6 weeks after diagnosis)
研究者
研究点 (1)
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