Biomarkers for Invasive Mucormycosis

NCT ID: NCT05406037

Last Updated: 2025-12-26

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-11-29
• Study Completion Date: 2026-07-31

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

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

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;

Venous sample

Intervention Type: 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)

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)

Venous sample

Intervention Type: BIOLOGICAL

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.

Venous sample

Intervention Type: BIOLOGICAL

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

Interventions

Venous sample

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

Intervention Type: BIOLOGICAL

Eligibility Criteria

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)

• Co-infection mucormycosis/other IFI

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Plateforme PAGés, Analyses Glycoconjugués

UNKNOWN

Sponsor Role: collaborator

Région Hauts de France, France

UNKNOWN

Sponsor Role: collaborator

SATT Nord

UNKNOWN

Sponsor Role: collaborator

University Hospital, Lille

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marjorie CORNU, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Lille

Locations

University Hospital of Lille

Lille, Hauts-de-France, France

Site Status: RECRUITING

Countries

France

Central Contacts

Marjorie CORNU, MD

Role: CONTACT

marjorie.cornu@chru-lille.fr

0320445962 ext. +33

Facility Contacts

Marjorie Cornu

Role: primary

marjorie.cornu@chru-lille.fr

Other Identifiers

2021-A03202-39

Identifier Type: OTHER

Identifier Source: secondary_id

2021_0462

Identifier Type: -

Identifier Source: org_study_id