BIM: Biomarkers for Invasive Mucormycosis

Sponsor

University Hospital, Lille (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05406037

Collaborator

Plateforme PAGés, Analyses Glycoconjugués (Other), Région Hauts de France, France (Other), SATT Nord (Other)

100

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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).

Condition or Disease	Intervention/Treatment	Phase
Mucorales Infection Mucormycosis	Biological: Venous sample

Study Design

Study Type:

Observational

Anticipated Enrollment :

100 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Jul 1, 2022

Anticipated Primary Completion Date :

Aug 1, 2024

Anticipated Study Completion Date :

Aug 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
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;	Biological: Venous sample at Day 0, Day 3, Day 7, Day 14, Day 28 (7 ml blood sample collecting on dry tube) D0 = Diagnostic day
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)	Biological: Venous sample at Day 0, Day 3, Day 7, Day 14, Day 28 (7 ml blood sample collecting on dry tube) D0 = Diagnostic day
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.	Biological: Venous sample at Day 0, Day 3, Day 7, Day 14, Day 28 (7 ml blood sample collecting on dry tube) D0 = Diagnostic day

Arm

Intervention/Treatment

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;

Biological: Venous sample

at Day 0, Day 3, Day 7, Day 14, Day 28 (7 ml blood sample collecting on dry tube) D0 = Diagnostic day

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)

Biological: Venous sample

at Day 0, Day 3, Day 7, Day 14, Day 28 (7 ml blood sample collecting on dry tube) D0 = Diagnostic day

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.

Biological: Venous sample

at Day 0, Day 3, Day 7, Day 14, Day 28 (7 ml blood sample collecting on dry tube) D0 = Diagnostic day

Outcome Measures

Primary Outcome Measures

Values of the biomarker studied in the patient group versus control groups, expressed as Optical density (OD). [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).

Secondary Outcome Measures

Kinetics of the biomarker value measured for hospitalized patients, expressed as Optical density (OD). [at Day 3, Day 7, Day 14 and Day 28]
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.
Number of participant with unfavorable clinical evolution (death at D28) [at day 28]
Description of the clinical evolution (death or survival at D28) in parallel with the kinetic of the biomarker value

Eligibility Criteria

Criteria

Ages Eligible for Study:

3 Years to 64 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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)