Markers of Infection and Resistance in Invasive Fusariosis

Fusariosis Clinical Trial

— FUSIMIR  

Official title:

Multicenter Study on Invasive Fusariosis : Looking for Markers of Infection and Resistance

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04937751
• Other study ID #: 2020PI202
• Status: Recruiting
• Start date: July 19, 2023
• Est. completion date: July 2028

Study information

• Verified date: February 2024
• Source: Central Hospital, Nancy, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: July 2028
• Est. primary completion date: July 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• Clinical diagnosis of superficial fusarium wilt (onychomycosis, etc.)

Related Conditions & MeSH terms

• Fusariosis

Intervention

Diagnostic Test:
• biomarkers
galactomannan, betaDglucan, resistance markers

Locations

Country	Name	City	State
France	CHRU Nancy	Vandoeuvre les nancy

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	proportions of different fungal species in positive fungal cultures in patients with invasive fungal infection (IFI) or fungal keratitis		2021-2026