Biomarkers for Invasive Mucormycosis (BIM)

University Hospital, Lille

Status: Enrolling

Conditions: Mucorales Infection; Mucormycosis

Treatments: Biological: Venous sample

Study type: Observational

Funder types: Other

Identifiers

NCT05406037

2021-A03202-39 (Other Identifier)

2021_0462

Details and patient eligibility

About

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).

Enrollment: 100 estimated patients

Sex: All

Ages: 3 to 64 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

100 participants in 3 patient groups

Patients with MM

Description:

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;

Treatment:

Biological: Venous sample

High-risk patients without MM (control group 1)

Description:

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)

Treatment:

Biological: Venous sample

Patients with another IFI (control group 2)

Description:

* 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.

Treatment:

Biological: Venous sample