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NCT Number: NCT04937751

Markers of Infection and Resistance in Invasive Fusariosis

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.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

CHRU Nancy

Vandœuvre-lès-Nancy, 54500, France

Location status: Recruiting

Location contact

Anne Debourgogne

CONTACT

[email protected]

+33383656074

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.)

Treatment and study plan

Biomarkers

Diagnostic Test

galactomannan, betaDglucan, resistance markers

Primary outcomes

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

    Time frame: 2021-2026

Sponsors and collaborators

Lead sponsor

Central Hospital, Nancy, France

Other

Registry information

Official study title

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

Acronym: FUSIMIR

Important dates

Study start
2023
Primary completion
2028
Study completion
2028
First posted
Jun 24, 2021
Registry last updated
Feb 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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