Markers of Infection and Resistance in Invasive Fusariosis

NCT ID: NCT04937751

Last Updated: 2024-02-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-07-19

Study Completion Date

2028-07-31

Brief Summary

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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

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Conditions

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Fusariosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Invasive fusariosis

biomarkers

Intervention Type DIAGNOSTIC_TEST

galactomannan, betaDglucan, resistance markers

Fusarium keratitis

biomarkers

Intervention Type DIAGNOSTIC_TEST

galactomannan, betaDglucan, resistance markers

Interventions

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biomarkers

galactomannan, betaDglucan, resistance markers

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.)
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Central Hospital, Nancy, France

OTHER

Sponsor Role lead

Responsible Party

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Anne DEBOURGOGNE

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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CHRU Nancy

Vandœuvre-lès-Nancy, , France

Site Status RECRUITING

Countries

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France

Facility Contacts

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Anne Debourgogne

Role: primary

+33383656074

Other Identifiers

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2020PI202

Identifier Type: -

Identifier Source: org_study_id

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