A Multicentre Randomised Controlled Trial Comparing the Current Standard Diagnostic Strategy for Invasive Aspergillosis to the New Diagnostic Strategy for Invasive Aspergillosis in High-Risk Haematology Patients in Order to Determine Which Strategy Results in the Lower Rates of Use of Empiric Antifungal Therapy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 240
- 试验地点
- 11
- 主要终点
- The proportion of patients treated with at least 1 course of empiric antifungal therapy as per protocol definition at 26 weeks following randomisation
研究概览
简要总结
Aspergillus is a fungus found in soil, on farms and on construction sites. In those whose immune system is impaired it causes severe infection. The people who are particularly at high-risk of infection with Aspergillus (which is called Invasive Aspergillosis)are those with acute leukaemia who are having chemotherapy and those post bone marrow transplantation. Currently 15% of those at high-risk develop Invasive Aspergillosis and 60-90% of those with Invasive Aspergillosis die.
The main reason for this high death rate is that our current diagnostic tests are not good at detecting infection or often only detect the infection at advanced stages when treatment is ineffective. Because of the limitations of current diagnostic tests the current practice is to give empiric antifungal therapy (EAFT) early to treat suspected Invasive Aspergillosis. However studies have demonstrated that this therapy has only resulted in a minor reduction in the mortality rates and it also causes significant drug toxicity. It is a suboptimal treatment modality.
New tests have recently been developed to diagnose Invasive Aspergillosis. These tests are for the detection of an Aspergillus protein in blood and for the detection of Aspergillus DNA in blood. Available data suggests that these new tests make an early diagnosis and seem to be able to monitor responses to treatment. However no study has been reported to date which demonstrates that the use of these tests can impact on important patient outcomes. This trial is being performed to determine whether the use of the new diagnostic tests to guide antifungal therapy will help improve treatment of Invasive Aspergillosis, reduce drug toxicity and reduce the death rate in the high-risk patients as compared with the current standard method of diagnosis and treatment with EAFT.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients fulfilling all the following criteria will be eligible for enrolment
- •Aged 18-80 years
- •Undergoing allogeneic haematopoietic stem cell transplantation (HSCT) for any reason OR Undergoing intensive combination chemotherapy for acute myeloid leukaemia (AML) or acute lymphoblastic leukaemia (ALL)
- •Has given written informed consent.
排除标准
- •Patients with any of the following will be ineligible for enrolment
- •Other immunocompromised states (e.g. HIV infection, solid organ transplantation, autoimmune conditions treated with immunosuppressants etc.) besides those outlined in the inclusion criteria above
- •Currently enrolled in an antifungal treatment trial (not an antifungal prophylaxis trial)
- •Past history of proven or probable IA (as per standardized definitions) during a previous cycle of chemotherapy
- •Currently have active IA or other active invasive fungal infection
- •Prior enrolment in this study
结局指标
主要结局
The proportion of patients treated with at least 1 course of empiric antifungal therapy as per protocol definition at 26 weeks following randomisation
时间窗: 26 weeks of follow-up
次要结局
- Invasive Aspergillosis related mortality rates(26 weeks of follow-up)
- Other invasive fungal infection-related (IFI) mortality rates(26 weeks of follow-up)
- All-cause mortality rates(26 weeks of follow-up)
- Nephrotoxicity rates(26 weeks of follow-up)
- Hepatotoxicity rates(26 weeks of follow-up)
- Total number of courses of empiric antifungal therapy(26 weeks of follow-up)
- Cost data associated with treatment and complications.(26 weeks of follow-up)
- Incidence of proven, probable and possible invasive aspergillosis(26 weeks of follow-up)
- Incidence of proven, probable and possible other invasive fungal disease besides invasive aspergillosis(26 weeks of follow-up)