Biomarkers for Invasive Mucormycosis

• Conditions: Mucormycosis; Mucorales Infection
• Interventions: Biological: Venous sample

• Registration Number: NCT05406037
• Lead Sponsor: University Hospital, Lille

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).

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-05
• Study First Submitted: 2022-05-20
• Study First Submitted QC: 2022-05-31
• Last Update Submitted: 2022-05-31
• Study First Posted: 2022-06-06
• Last Update Posted: 2022-06-06
• Study Start: 2022-07
• Primary Completion: 2024-08
• Study Completion: 2024-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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 :

  1. 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

  2. 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

  3. 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
High-risk patients without MM (control group 1)	Venous sample	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)
Patients with MM	Venous sample	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;
Patients with another IFI (control group 2)	Venous sample	* 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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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