Biomarkers for Invasive Mucormycosis

Study Overview
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Brief Summary
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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).

Official Title
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Diagnostic Marker of Mucormycosis : Development and Evaluation of a Diagnostic Assay on a Cohort of Sera

Conditions
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Mucorales Infection, Mucormycosis

Intervention / Treatment
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* Biological: Venous sample


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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) Exclusion Criteria: Patients for whom the inclusion criteria are not met Co-infection mucormycosis/other IFI

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with MM<br>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; | Biological: Venous sample<br>* at Day 0, Day 3, Day 7, Day 14, Day 28 (7 ml blood sample collecting on dry tube) D0 = Diagnostic day<br>|
| High-risk patients without MM (control group 1)<br>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) | Biological: Venous sample<br>* at Day 0, Day 3, Day 7, Day 14, Day 28 (7 ml blood sample collecting on dry tube) D0 = Diagnostic day<br>|
| Patients with another IFI (control group 2)<br>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. | Biological: Venous sample<br>* at Day 0, Day 3, Day 7, Day 14, Day 28 (7 ml blood sample collecting on dry tube) D0 = Diagnostic day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Values of the biomarker studied in the patient group versus control groups, expressed as Optical density (OD). | 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). | at Day 0 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Kinetics of the biomarker value measured for hospitalized patients, expressed as Optical density (OD). | At each day of interest (at Day 3, Day 7, Day 14 and Day 28), values of OD obtained with an in-house immunoenzymatic sandwich microplate assay for the detection of a specific carbohydrate epitope of Mucorales will be reported for each sera. | at Day 3, Day 7, Day 14 and Day 28 | 
| Number of participant with unfavorable clinical evolution (death at D28) | Description of the clinical evolution (death or survival at D28) in parallel with the kinetic of the biomarker value | at day 28 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mucormycosis, Invasive fungal infection, Cell wall oligo/polysaccharides, Biomarkers