Markers of Infection and Resistance in Invasive Fusariosis

NCT04937751 | Recruiting

• 1 other identifier: 2020PI202
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Fusariosis

Outcome Measures

Primary Outcomes (1)

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

  2021-2026

Study Arms (2)

Invasive fusariosis

Diagnostic Test: biomarkers

Fusarium keratitis

Diagnostic Test: biomarkers

Interventions

biomarkers DIAGNOSTIC_TEST

galactomannan, betaDglucan, resistance markers

Fusarium keratitis; Invasive fusariosis

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study will have 2 parts: 1. a first descriptive section carried out through a study of 2 cohorts of patients (patients suspected of IFI / with a diagnosis of keratitis) for whom a fungal culture is carried out; 2. a second descriptive part (then potentially comparative if the statistical power is sufficient) carried out through 2 case-control studies nested in each of the patient cohorts (patients suspected of IFI / with a diagnosis of keratitis): these studies will consist of a population of cases (patients with Fusarium wilt) and 1 or 2 populations of controls (patients with negative culture on the one hand and patients with positive culture for a fungus of another genus in Fusarium on the other hand for invasive fusarioses).

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead

Study Sites (1)

CHRU Nancy

Vandœuvre-lès-Nancy, 54500, France

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood and fungal strains

MeSH Terms

Conditions

Fusariosis

Interventions

Environmental Biomarkers

Condition Hierarchy (Ancestors)

Hyalohyphomycosis; Dermatomycoses; Mycoses; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Biomarkers; Biological Factors; Biological Phenomena; Environmental Monitoring; Environmental Exposure; Environmental Pollution; Public Health; Environment and Public Health

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: June 16, 2021
• First Posted: June 24, 2021
• Study Start: July 19, 2023
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2028
• Last Updated: February 23, 2024

Record last verified: 2024-02

Locations

FR (1)