Diagnostic Marker of Mucormycosis : Development and Evaluation of a Diagnostic Assay on a Cohort of Sera
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Values of the biomarker studied in the patient group versus control groups, expressed as Optical density (OD).
研究概览
简要总结
Mucormycosis (MM) is one of the main invasive fungal infection (IFI), and is determined by filamentous fungi belonging to the order of Mucorales, with a mortality rate ranging from 20 to 60% according to localization. Prompt initiation of adequate antifungal therapy is critical for treating mucormycosis. Early diagnostic is therefore essential. The presence in the Mucorales' cell wall of uncommon monosaccharides open interesting perspectives for the development of specific diagnostic biomarkers.
This study evaluate a diagnostic test for mucormycosis in a cohort of patients with MM and in control groups (high-risk patients without MM and patients with another IFI).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 3 Years 至 64 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men and women
- •Age : Children and adults from 3 to 64 years old (18 to 64 for controls)
- •In patients whose consent has been collected after information. In the case of children, information on the study will be given to the holders of parental authority and then to the child to obtain their consent.
- •Patient social insured
- •Specific medical conditions :
- •For the case group :
- •Any patient hospitalized in one of the departments of the University Hospital of Lille, in which the diagnosis of mucormycosis was conducted on the following criteria:
- •Conventional mycology data and / or
- •Positivity of q-PRC and / or
- •Anatomopathologic diagnosis Associated with a compatible clinical situation
- •For the control group 1 Patient assessed for hematopoietic stem cell transplantation, considered at risk for IFI but for whom the pre-transplantation review will have excluded an ongoing infection
- •For control group 2 Any patient hospitalized in a department of Lille University Hospital, in which the diagnosis of disseminated candidiasis or invasive pulmonary aspergillosis has been made according to specific classifications (EORTC/MSG criteria, AspICU criteria)
排除标准
- •Patients for whom the inclusion criteria are not met
- •Co-infection mucormycosis/other IFI
研究组 & 干预措施
Patients with MM
Age : from 3 to 75 years old ;
- Specific medical conditions : patient hospitalized in one of the departments of the University Hospital of Lille or Amiens, in whom the diagnosis of mucormycosis will have been made on the criteria below, with compatible clinical and radiological evolution :
- conventional mycology data and/or
- positive q-PCR and/or
- pathology data confirmed by PCR;
干预措施: Venous sample (Biological)
High-risk patients without MM (control group 1)
Age : from 18 to 75 ;
- Specific medical conditions : patients hospitalized at the University Hospital of Lille or Amiens for whom a diagnosis of candidiasis or invasive aspergillosis has been made according to specific classifications (EORTC/MSG criteria, AspICU criteria)
干预措施: Venous sample (Biological)
Patients with another IFI (control group 2)
- Age : from 18 to 75 ;
- Specific medical conditions : patients undergoing assessment for haematopoietic stem cell transplantation, considered at risk of invasive fungal infection but for whom the pre-transplant assessment will have excluded an ongoing infection.
干预措施: Venous sample (Biological)
结局指标
主要结局
Values of the biomarker studied in the patient group versus control groups, expressed as Optical density (OD).
时间窗: at Day 0
Detection and quantification of the oligosaccharide biomarker will be performed using a sandwich type enzyme-linked immunosorbent assay (ELISA).Biomarker values could also be reported in arbitrary units / mL (plotting the calibration curve).
次要结局
- Kinetics of the biomarker value measured for hospitalized patients, expressed as Optical density (OD).(at Day 3, Day 7, Day 14 and Day 28)
- Number of participant with unfavorable clinical evolution (death at D28)(at day 28)