Biomarkers for Invasive Mucormycosis

NCT05406037 | Recruiting

• 2 other identifiers: 2021_04622021-A03202-39
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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).

Conditions

Mucorales Infection; Mucormycosis

Keywords

Mucormycosis; Invasive fungal infection; Cell wall oligo/polysaccharides; Biomarkers

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

Study Arms (3)

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

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

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

Interventions

Venous sample BIOLOGICAL

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); Patients with MM; Patients with another IFI (control group 2)

Eligibility Criteria

• Age: 3 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients cared for at the University Hospitals of Lille and Amiens (France)

You may qualify if:

• 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)

You may not qualify if:

• Co-infection mucormycosis/other IFI

Sponsors & Collaborators

• University Hospital, Lille: lead
• Région Hauts de France, France: collaborator
• SATT Nord: collaborator
• Plateforme PAGés, Analyses Glycoconjugués: collaborator

Study Sites (1)

University Hospital of Lille

Lille, Hauts-de-France, 59000, France

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

serum

MeSH Terms

Conditions

Mucormycosis; Invasive Fungal Infections

Condition Hierarchy (Ancestors)

Zygomycosis; Mycoses; Bacterial Infections and Mycoses; Infections

Study Officials

• Marjorie CORNU, MD

  University Hospital, Lille

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marjorie CORNU, MD

CONTACT

0320445962; marjorie.cornu@chru-lille.fr

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2022
• First Posted: June 6, 2022
• Study Start: November 29, 2023
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: December 26, 2025

Record last verified: 2025-01

Locations

FR (1)