Performance of Emerging Microbiological Techniques for the Diagnosis of Severe Infections in Neutropenic Patients With Haematological Malignancies
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Sensitivity and specificity of T2MR as compared to Blood Cultures for the diagnosis of proven, probable, and possible BSI as previously defined
研究概览
简要总结
Mortality due to bloodstream infections in patients with neutropenia and haematological malignancies is high and optimal management is hampered by long turnaround times of conventional blood cultures.
This is an observational study to assess the performance of T2 magnetic resonance, in diagnosing proven, probable and possible bloodstream infections as well as its theoretical impact on antimicrobial prescriptions in neutropenic patients with acute leukemia and bone marrow recipients.
详细描述
Study Background
In patients with haematological malignancies, neutropenia often leads to the development of severe infections, including bloodstream, which are characterized by high mortality. Patients' management can be challenging as conventional diagnostic methods for the diagnosis of such infections are affected by several limitations, including limited sensitivity and long turnaround time.
T2 Magnetic Resonance (T2MR) is a new technology able to identify pathogens directly from whole blood in few hours, and preliminary data showed how it might have higher sensitivity compared to blood cultures.
Study Aims
- To assess the performance of the T2MR (including the T2Candida, T2Bacteria and T2Resistance) in diagnosing proven, probable, and possible bloodstream infection (BSI) due to T2 on-panel pathogens, in patients affected by haematological malignancies with febrile neutropenia, including patients with acute leukaemia and bone marrow transplant recipients.
- To assess the mean time to results of the T2MR 3 panels as compared to blood cultures. These will be considered as an estimate of time to optimal treatment in proven, probable, and possible BSI.
- To estimate the potential impact of T2MR results on antimicrobial modifications in neutropenic patients with proven/probable and possible BSI.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients (> 18 years old) affected by acute leukaemia and/or recipients of bone marrow transplantation for any disease indication (during the pre and post-transplant phase) who develop febrile neutropenia, where blood cultures (and possibly bronchoscopy) are ordered as per standard of care.
- •Febrile neutropenia is defined as:
- •an ANC of <500 cells/mm3
- •a single temperature measurement of ≥38.0°C
排除标准
- •Patients not able to provide informed consent
- •Death is deemed imminent
结局指标
主要结局
Sensitivity and specificity of T2MR as compared to Blood Cultures for the diagnosis of proven, probable, and possible BSI as previously defined
时间窗: 01/04/2022 - 31/03/2023
Sensitivity and specificity of T2 magnetic resonance will be calculated with 95% confidence intervals both for pathogen identification and resistance markers detection
次要结局
- In patients with positive T2 results: Mean time to result of T2MR(01/04/2022 - 31/03/2023)
- In patients with positive T2 results: percentage of potential antimicrobial modifications according to T2 results(01/04/2022 - 31/03/2023)