Biomarkers for Invasive Mucormycosis

Mucormycosis Clinical Trial

— BIM  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05406037
• Other study ID #: 2021_0462
• Secondary ID: 2021-A03202-39
• Status: Not yet recruiting
• Start date: July 2022
• Est. completion date: August 2024

Study information

• Verified date: May 2022
• Source: University Hospital, Lille
• Contact: Marjorie CORNU, MD
• Phone: 0320445962
• Email: marjorie.cornu[@]chru-lille.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: August 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Mucormycosis
• Zygomycosis

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
University Hospital, Lille	Plateforme PAGés, Analyses Glycoconjugués, Région Hauts de France, France, SATT Nord

Outcome

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