Markers of Infection and Resistance in Invasive Fusariosis (FUSIMIR)

February 22, 2024 updated by: Anne DEBOURGOGNE, Central Hospital, Nancy, France

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

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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).

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Invasive fusariosis
Diagnostic test: biomarkers
galactomannan, betaDglucan, resistance markers
Fusarium keratitis
Diagnostic test: biomarkers
galactomannan, betaDglucan, resistance markers

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
proportions of different fungal species in positive fungal cultures in patients with invasive fungal infection (IFI) or fungal keratitis
Time Frame: 2021-2026
2021-2026

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Central Hospital, Nancy, France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 19, 2023

Primary Completion (Estimated)

July 1, 2028

Study Completion (Estimated)

July 1, 2028

Study Registration Dates

First Submitted

June 16, 2021

First Submitted That Met QC Criteria

June 16, 2021

First Posted (Actual)

June 24, 2021

Study Record Updates

Last Update Posted (Actual)

February 23, 2024

Last Update Submitted That Met QC Criteria

February 22, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020PI202

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Fusariosis

Clinical Trials on biomarkers

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in South Africa

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe