Real-time Breath Analysis for the Detection of Invasive Fungal Infections in Neutropenic High-risk Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- Novel biomarker (m/z value) for IFI by SESI-HRMS
研究概览
简要总结
Patients with leukemia and concomitant neutropenia are at high risk of developing invasive fungal infections (IFI) that are associated with high morbidity and mortality. As these patients typically have severe thrombocytopenia, direct diagnostic sampling with invasive procedures is often not possible due to the high peri-interventional risk. Therefore, the presumptive diagnosis of IFI is primarily based on compatible lung findings on computed tomography and serologic detection of fungal cell wall components, which, however, have limited sensitivity and specificity.
With the present study, the investigators aim to determine a set of specific volatile biomarkers in leukemia patients with proven or probable IFI using secondary electrospray ionization high-resolution mass spectrometry (SESI-HRMS).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 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
- •Diagnosis of acute leukemia
- •Planned chemotherapy with a duration of hospitalisation of 2 weeks or longer
- •Neutropenia (<500/µl) present at inclusion or planned chemotherapy with expected neutropenia (<500/µl) for more than 7 days
排除标准
- •Unable to follow instructions for breath analysis
- •Anatomic abnormalities precluding the use of a mouthpiece for breath analysis
结局指标
主要结局
Novel biomarker (m/z value) for IFI by SESI-HRMS
时间窗: through study completion, on average after 3 weeks
Feature in Mass Spectrometry
次要结局
- Anticipation of IFI(through study completion, on average after 3 weeks)
- Specificity and sensitivity of this novel biomarker(through study completion, on average after 3 weeks)
研究者
Jeremy Deuel
Principal Investigaor
University of Zurich