Optimized Diagnostics for Improved Therapy Stratification in Invasive Fungal Infections
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 244
- 试验地点
- 7
- 主要终点
- Number of patients with fungal DNAmia (as indicator of fungal infection) detected by new methodologies described in the proposal
研究概览
简要总结
Invasive fungal infections (IFI) in immunocompromised patients pose a major challenge for diagnostics designed to permit timely onset of appropriate treatment. The aim of the current clinical-diagnostic studies, one in in pediatric and one in adult patients at high risk of IFI, is to test newly developed diagnostic approaches to invasive fungal infections in relation to established procedures. The studies will be performed in a prospective, blinded fashion, and represent a work package within the FUNGITECT grant supported by the European Commission. The studies will focus on analyses of blood-samples from patients with febrile neutropenia during treatment of acute leukaemia and other tumour entities, and patients undergoing allogeneic stem cell transplantation treated with intensive chemotherapy.
详细描述
Samples from immunosuppressed patients with febrile neutropenia (NP - defined as fever ≥ 38.5ºC and <500 ANC) will be taken:
- at the start of neutropenic fever
- after 24 hours
- after 48 hours
- before the start of antimycotic therapy, if pertinent
- at the end of antimycotic therapy, if pertinent
The results ot analyses by a panfungal PCR screening assay developed at our institution (European patent No 1960536) and methods newly developed during the FUNGITECT project will be compared with conventional methods for fungal diagnostics such as HR (High Resolution)-CT, serological testing, histology and fungal culture. Additionally, genomic approaches will be employed to investigate host- and pathogen-related factors of susceptibility, pathogenicity and antimycotic resistance.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 6 Months 至 90 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Number of patients with fungal DNAmia (as indicator of fungal infection) detected by new methodologies described in the proposal
时间窗: until the end of antifungal treatment (up to 6 weeks after the onset of febrile neutropenia)
Invasive fungal diseases will be evaluated by developing improved diagnosis: technical validation of individual assays (PCR-based, NGS, and protein-based), validation of biomarkers in clinical specimens (MoAbs, proteinaceous infection markers) and optimized for time and parallel processing of samples by establishing a robust protocol to generate reproducible results, implementation of automated or semi-automated techniques and by use of defined quality control systems.
Frequency of individual fungal pathogens during febrile neutropenia in high risk patients
时间窗: until the end of antifungal treatment (up to 6 weeks after the onset of febrile neutropenia)
The frequency of invasive fungal disease in the paediatric and adult patient cohorts as well as in each individual patient will be elucidated.
Frequency of fungal pathogens resistant to commonly used antifungal agents
时间窗: until the end of antifungal treatment (up to 6 weeks after the onset of febrile neutropenia)
Progress and changes in healthcare practices provide opportunities for new and drug-resistant fungal pathogens emerging in hospital settings.
次要结局
- Number of lethal fungal infections(until the end of antifungal treatment (up to 6 weeks after the onset of febrile neutropenia))