Markers of Infection and Resistance in Invasive Fusariosis

Recruiting

• Conditions: Fusariosis
• Interventions: Diagnostic Test: biomarkers

• Registration Number: NCT04937751
• Lead Sponsor: Central Hospital, Nancy, France

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-06-16
• Study First Submitted QC: 2021-06-16
• Study First Posted: 2021-06-24
• Study Start: 2023-07-19
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-22
• Last Update Posted: 2024-02-23
• Primary Completion: 2028-07
• Study Completion: 2028-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

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.)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Fusarium keratitis	biomarkers	-
Invasive fusariosis	biomarkers	-

Primary Outcome Measures

Name	Time	Method
proportions of different fungal species in positive fungal cultures in patients with invasive fungal infection (IFI) or fungal keratitis	2021-2026

Trial Locations

Locations (1)

CHRU Nancy; 🇫🇷 Vandoeuvre les nancy, France