FusariosisFUSIMIRNCT04937751
Markers of Infection and Resistance in Invasive Fusariosis
An observational study of Fusariosis, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
In recent decades, invasive fusarioses have been emerging fungal pathologies with high mortality. The prognosis depends on the speed of the diagnosis, but currently biological diagnosis is mainly based on fungal culture, no specific biomarker for this microorganism is available in current clinical practice. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Fusariosis
- What is being tested?
- biomarkers
- How many people
- 150 participants
- Where
- 1 siteFrance
- Study dates
- 19 Jul 2023to Jul 2028
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study will have 2 parts: 1. a first descriptive section carried out through a study of 2 cohorts of patients (patients suspected of IFI / with a diagnosis of keratitis) for whom a fungal culture is carried out; 2. a second descriptive part (then potentially comparative if the statistical power is sufficient) carried out through 2 case-control studies nested in each of the patient cohorts (patients suspected of IFI / with a diagnosis of keratitis): these studies will consist of a population of cases (patients with Fusarium wilt) and 1 or 2 populations of controls (patients with negative culture on the one hand and patients with positive culture for a fungus of another genus in Fusarium on the other hand for invasive fusarioses).
Who may be able to join
- Suspicion of invasive fungal infection involving the performance of a blood culture or a skin biopsy or diagnosis of keratitis involving the taking of a cornea sample
- Fungal culture carried out on this sample
- Person having been informed of the research and not having opposed the use of their data
Who cannot join
- Clinical diagnosis of superficial fusarium wilt (onychomycosis, etc.)
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
CHRU Nancy
Vandœuvre-lès-Nancy, 54500
Anne Debourgogne, +33383656074, a.debourgogne@chru-nancy.fr
About this study
Official title: Multicenter Study on Invasive Fusariosis : Looking for Markers of Infection and Resistance
In recent decades, invasive fusarioses have been emerging fungal pathologies with high mortality. The prognosis depends on the speed of the diagnosis, but currently biological diagnosis is mainly based on fungal culture, no specific biomarker for this microorganism is available in current clinical practice. The genus Fusarium also shows reduced sensitivity to antifungals commonly used and recommended in clinical practice, such as voriconazole or amphotericin B.
The main objective of this study is to describe the proportions of different fungal species in positive fungal cultures in patients with invasive fungal infection (IFI) or fungal keratitis. The secondary objectives are the description of the dosage of galactomannans, beta (1,3) -D-glucans and the rate of detection of DNA circulating in case / control groups for the 2 clinical forms studied. In patients with evidence of Fusarium wilt, the study will describe the distribution of the different minimum inhibitory concentrations (MIC) depending on whether or not different antifungals are taken, the vital status at 3 months, and the response or not to treatment. Finally, the presence of genetic markers will be described according to the groups of MIC values.
- Conditions
- Fusariosis
- Being tested
- biomarkers
- Medical subject headings
- Fusariosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
biomarkersDiagnostic test
galactomannan, betaDglucan, resistance markers
| Study group | Role | What they receive |
|---|---|---|
| Invasive fusariosis | Not described Receives: Diagnostic Test: biomarkers | |
| Fusarium keratitis | Not described Receives: Diagnostic Test: biomarkers |
What is being measured
The primary outcome is the main question the study is designed to answer.
proportions of different fungal species in positive fungal cultures in patients with invasive fungal infection (IFI) or fungal keratitis
Measured: 2021-2026
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2021
- Study start19 Jul 2023
- Primary completionJul 2028 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FusariosisStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anne DEBOURGOGNE, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04937751
- Sponsor's protocol ID
- 2020PI202
- Acronym
- FUSIMIR
- Status last verified
- Feb 2024
- First submitted
- 16 Jun 2021
- Last updated
- 23 Feb 2024
- 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 23 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Study on Invasive Fusariosis : Looking for Markers of Infection and Resistance
- ClinicalTrials.gov ID
- NCT04937751
- Acronym / sponsor ID
- FUSIMIR / 2020PI202
- Conditions
- Fusariosis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 19 Jul 2023 (actual)
- Primary completion
- Jul 2028 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 24 Jun 2021 (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.
In recent decades, invasive fusarioses have been emerging fungal pathologies with high mortality. The prognosis depends on the speed of the diagnosis, but currently biological diagnosis is mainly based on fungal culture, no specific biomarker for this microorganism is available in current clinical practice. The genus Fusarium also shows reduced sensitivity to antifungals commonly used and recommended in clinical practice, such as voriconazole or amphotericin B.
The main objective of this study is to describe the proportions of different fungal species in positive fungal cultures in patients with invasive fungal infection (IFI) or fungal keratitis. The secondary objectives are the description of the dosage of galactomannans, beta (1,3) -D-glucans and the rate of detection of DNA circulating in case / control groups for the 2 clinical forms studied. In patients with evidence of Fusarium wilt, the study will describe the distribution of the different minimum inhibitory concentrations (MIC) depending on whether or not different antifungals are taken, the vital status at 3 months, and the response or not to treatment. Finally, the presence of genetic markers will be described according to the groups of MIC values.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Invasive fusariosis | – | Diagnostic Test: biomarkers |
| Fusarium keratitis | – | Diagnostic Test: biomarkers |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study will have 2 parts: 1. a first descriptive section carried out through a study of 2 cohorts of patients (patients suspected of IFI / with a diagnosis of keratitis) for whom a fungal culture is carried out; 2. a second descriptive part (then potentially comparative if the statistical power is sufficient) carried out through 2 case-control studies nested in each of the patient cohorts (patients suspected of IFI / with a diagnosis of keratitis): these studies will consist of a population of cases (patients with Fusarium wilt) and 1 or 2 populations of controls (patients with negative culture on the one hand and patients with positive culture for a fungus of another genus in Fusarium on the other hand for invasive fusarioses).
Key inclusion criteria (3 listed)
- Suspicion of invasive fungal infection involving the performance of a blood culture or a skin biopsy or diagnosis of keratitis involving the taking of a cornea sample
- Fungal culture carried out on this sample
- Person having been informed of the research and not having opposed the use of their data
Key exclusion criteria (1 listed)
- Clinical diagnosis of superficial fusarium wilt (onychomycosis, etc.)
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 |
|---|---|---|
| biomarkersgalactomannan, betaDglucan, resistance markers | Diagnostic test | Fusarium keratitis, Invasive fusariosis |
Primary outcome
proportions of different fungal species in positive fungal cultures in patients with invasive fungal infection (IFI) or fungal keratitis
Time frame: 2021-2026
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 23 Feb 2024.
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.
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 Fusariosis, run by Central Hospital, Nancy, France 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 3 inclusion and 1 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 23 Feb 2024. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
proportions of different fungal species in positive fungal cultures in patients with invasive fungal infection (IFI) or fungal keratitis (time frame: 2021-2026). 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 23 Feb 2024; AzTrials last refreshed its copy on 8 Nov 2026.