Early Diagnosis and Treatment of Infections in Patients With Haematologic Malignancies: Examining Novel Diagnostics Including Bacterial and Fungal Multiplex PCR and FDG-PET Imaging
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 147
- 试验地点
- 2
- 主要终点
- Change in management following randomized scan
研究概览
简要总结
Patients with acute leukaemia requiring induction or consolidation chemotherapy and those requiring a haematopoietic stem cell transplant are at high risk of fever and infection when they have low white cell counts (neutropenic fever). The causes of neutropenic fever are frequently unknown and patients are treated with broad antibiotics, without a clear target to what is being treated.
This study will prospectively enroll patients who are receiving chemotherapy for acute leukaemia or for a stem cell transplant and compare the diagnostic utility of bacterial and fungal PCR performed directly off blood drawn, to the standard blood culture. Patients who have persistent fever after 72 hours of antibiotics will then be randomized to have either the interventional scan (PET/CT) or the conventional scan (standard CT) to look for a source of infection. Diagnostic yield, change in management and outcomes will be compared between arms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
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
- •About to have an allogeneic haematopoietic stem cell transplant, OR
- •About to have an autologous haematopoietic stem cell transplant, OR
- •Commencing induction or consolidation chemotherapy with curative intent for acute myeloid or acute lymphoid leukaemia
排除标准
- •Current actively diagnosed infection prior to transplant or chemotherapy
- •Allergy to intravenous contrast for CT imaging
- •eGFR <30
研究组 & 干预措施
FDG-PET/CT arm
Participants with persistent febrile neutropenia after 72 hours of onset who are randomized to this arm will have an FDG-PET/CT performed to look for source of fever.
干预措施: FDG-PET/CT (Diagnostic Test)
Conventional CT arm
Participants with persistent febrile neutropenia after 72 hours of onset who are randomized to this arm will have a conventional CT (HRCT chest and sinuses +/- other regions as per clinician's discretion) performed to look for source of fever.
干预措施: Conventional CT (Diagnostic Test)
结局指标
主要结局
Change in management following randomized scan
时间窗: Within 48 hours of scan result
Defined as: * referral for targeted sampling, referral for surgery * change in antimicrobial therapy * removal of a central line
次要结局
- Proportion of participants with a cause of neutropenic fever(By hospital discharge, an average of 4 weeks)
- In hospital mortality(By hospital discharge, an average of 4 weeks)
- Hospital length of stay(By hospital discharge, an average of 4 weeks)
- Proportion admitted to intensive care(By hospital discharge, an average of 4 weeks)
- 6 month mortality(6 months from study entry)
- Costs of hospital care(By hospital discharge, an average of 4 weeks)