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Clinical Trials/NCT04937751
NCT04937751RecruitingNot Applicable

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

Central Hospital, Nancy, France1 site in 1 country150 target enrollmentStarted: July 19, 2023Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Sponsor
Enrollment
150
Locations
1
Primary Endpoint
proportions of different fungal species in positive fungal cultures in patients with invasive fungal infection (IFI) or fungal keratitis

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
No

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.)

Outcomes

Primary Outcomes

proportions of different fungal species in positive fungal cultures in patients with invasive fungal infection (IFI) or fungal keratitis

Time Frame: 2021-2026

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Central Hospital, Nancy, France
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Anne DEBOURGOGNE

Principal investigator

Central Hospital, Nancy, France

Study Sites (1)

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