Mucorales InfectionBIMNCT05406037
Biomarkers for Invasive Mucormycosis
An observational study of Mucorales Infection and Mucormycosis, run by University Hospital, Lille at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 3 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Mucorales Infection, Mucormycosis
- What is being tested?
- Venous sample
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 29 Nov 2023to Jul 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 64 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Patients cared for at the University Hospitals of Lille and Amiens (France)
Who may be able to join
- 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 :
Show all 12Show fewer
- 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)
Who cannot join
- Patients for whom the inclusion criteria are not met
- Co-infection mucormycosis/other IFI
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
University Hospital of Lille
Lille, Hauts-de-France, 59000
Marjorie Cornu, marjorie.cornu@chru-lille.fr
About this study
Official title: Diagnostic Marker of Mucormycosis : Development and Evaluation of a Diagnostic Assay on a Cohort of Sera
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
- Being tested
- Venous sample
- Keywords
- Mucormycosis, Invasive fungal infection, Cell wall oligo/polysaccharides, Biomarkers
- Medical subject headings
- Mucormycosis, Invasive Fungal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Venous sampleBiological
at Day 0, Day 3, Day 7, Day 14, Day 28 (7 ml blood sample collecting on dry tube) D0 = Diagnostic day
| Study group | Role | What they receive |
|---|---|---|
| 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; Receives: 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) Receives: 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. Receives: Biological: Venous sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: at Day 0
Secondary outcomes (2)
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.
Measured: at Day 3, Day 7, Day 14 and Day 28
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
Measured: at day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2022
- Study start29 Nov 2023
- Primary completionJul 2026 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mucorales InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Collaborators
- Plateforme PAGés, Analyses Glycoconjugués, Région Hauts de France, France, SATT Nord
- Responsible party
- Sponsor
- Investigators
- Marjorie CORNU, MD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05406037
- Sponsor's protocol ID
- 2021_0462
- Other IDs
- 2021-A03202-39
- Acronym
- BIM
- Status last verified
- May 2026
- First submitted
- 20 May 2022
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Marker of Mucormycosis : Development and Evaluation of a Diagnostic Assay on a Cohort of Sera
- ClinicalTrials.gov ID
- NCT05406037
- Acronym / sponsor ID
- BIM / 2021_0462
- Conditions
- Mucorales Infection, Mucormycosis
- Keywords
- Mucormycosis, Invasive fungal infection, Cell wall oligo/polysaccharides, Biomarkers
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Collaborators
- Plateforme PAGés, Analyses Glycoconjugués, Région Hauts de France, France, SATT Nord
- Study start
- 29 Nov 2023 (actual)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 6 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients with MM | – | Biological: Venous sampleAge : 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; |
| High-risk patients without MM (control group 1) | – | Biological: Venous sampleAge : 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 another IFI (control group 2) | – | Biological: 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. |
Who may qualify
- Ages
- 3 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Patients cared for at the University Hospitals of Lille and Amiens (France)
Key inclusion criteria (12 listed)
- 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 :
Key exclusion criteria (2 listed)
- Patients for whom the inclusion criteria are not met
- Co-infection mucormycosis/other IFI
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Venous sampleat Day 0, Day 3, Day 7, Day 14, Day 28 (7 ml blood sample collecting on dry tube) D0 = Diagnostic day | Biological | High-risk patients without MM (control group 1), Patients with MM, Patients with another IFI (control group 2) |
Primary outcome
Values of the biomarker studied in the patient group versus control groups, expressed as Optical density (OD).
Time frame: 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).
2 secondary outcomes
Kinetics of the biomarker value measured for hospitalized patients, expressed as Optical density (OD).
Time frame: at Day 3, Day 7, Day 14 and Day 28
Number of participant with unfavorable clinical evolution (death at D28)
Time frame: at day 28
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Marjorie CORNU, MD principal investigator
University Hospital, Lille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mucorales Infection and Mucormycosis, run by University Hospital, Lille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marjorie CORNU, MD (0320445962 ext. +33, marjorie.cornu@chru-lille.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Values of the biomarker studied in the patient group versus control groups, expressed as Optical density (OD). (time frame: at Day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.