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临床试验/NCT05925660
NCT05925660招募中不适用

Mucorales PCR Screening in At-risk Hematology Patients

Universitaire Ziekenhuizen KU Leuven2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2023年11月6日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
80
试验地点
2
主要终点
Incidence of a positive Mucorales PCR screening test

研究概览

简要总结

Patients with leukemia are treated with intensive chemotherapy and often have to undergo a stem cell transplantation which makes their immune system extremely vulnerable. This puts them at risk for invasive fungal infections, of which invasive mucormycosis (IM) is one of the most dangerous ones. Treatment of IM is complex and mortality rates are still extremely high, ranging from 40% to 80% and sometimes even higher if the central nervous system is involved. Mucormycosis requires immediate intervention due to the rapidly progressive and destructive nature of the infection. But the diagnosis is often made too late...

Better survival can be achieved with a faster diagnosis. A new test has recently been developed for detection of Mucorales DNA by PCR. The polymerase chain reaction (PCR) is a method that allows to quickly make millions of copies of, for example, Mucorales DNA in order to detect it in the blood at an early stage. Because blood can easily be obtained, without an additional burden on the patient, the test could be interesting for screening for these infections, which then offers the opportunity to start an adequate treatment more quickly.

However, the test is now only performed if there is a clinical suspicion of IM. But at that point, precious time has already been lost, and often the patient can no longer be cured. In this study the utility of the Mucorales PCR as a possible screening test in at-risk patients is assessed. The participants, hospitalised patients with leukemia, will be screened twice weekly with a Mucorales PCR test during their most vulnerable period. If the study shows that the test helps in diagnosing IM faster, this could have an important impact on the treatment and survival of these at-risk patients.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Screening
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

入选标准

  • Underlying disease:
  • Start of remission induction chemotherapy for acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) that is newly diagnosed or in first relapse after hematological remission lasting for a minimum duration of 6 months; OR
  • Start of myeloablative conditioning regimen to prepare for a first allogeneic hematopoietic cell transplantation (HCT).
  • Expected prolonged neutropenia (ANC< 0.5 x 109 /L for ≥ 7 days).
  • Planned hospital admission for the duration of the neutropenic phase.

排除标准

  • 未提供

结局指标

主要结局

Incidence of a positive Mucorales PCR screening test

时间窗: 3 months

次要结局

  • Was antifungal therapy started based on Mucorales PCR result? Y/N(3 months)
  • Incidence of invasive mucormycosis(3 months)
  • Outcome of patients with a positive Mucorales PCR versus these without: death or survival at 3 months(3 months)
  • Number of days antifungal therapy was given (amphotericin B, azoles)(3 months)
  • Incidence of invasive aspergillosis and invasive mucormycosis coinfections(3 months)
  • Was antifungal therapy stopped based on Mucorales PCR result? Y/N(3 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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