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Not yet recruiting NCT06532227

AspergillusOne-Health: Deciphering Azole Resistance in Aspergillus Fungi Using a One Health Approach

Observational Aspergillus Fumigatus Infection

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: No intervention.
Who it may be relevant to
Registry conditions: Aspergillus Fumigatus Infection. Basic parameters: 18 years — 99 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

During a two year prospective study onpatients from department's hospitals and centralized by the pneumology department Nantes CH,all respiratory clinical samples will be cultivated for Aspergillus isolation (2900Aspergillusisolates) as standard care. The azole susceptibility pattern of isolates will be determined to itraconazole, voriconazole by subculture on azole- enriched medium at 35°c as primary screen and resistance confirmed by EUCAST Reference metho.In parallel, the relevance of detecting resistance (TR34 and TR46) directly in culture-negative BAL respiratory samples by a qPCR method will be studied in an attempt to reach a greater exhaustiveness of the resistance phenomeno. In case of azole-resistant isolate,patient data such as the underlying disease,date and site of Aspergillus isolation,disease classification,previous azole drug exposure,and home and work geographic allocation,occupation of the patient will be collecte. For all other aspergillus occurrences, underlying disease, previous azole drug exposure,home and work location of the patient will be collected in an attempt to identify risk factor.

Interventions

  • Other No intervention
    No intervention excepted data collection

Primary outcome measures

  • Environmental risk factors [Time frame: 24 months]
Secondary outcome measures (2)
  • Describe the management and evolution of resistant [Time frame: 48 months]
  • Risk factors [Time frame: 48 months]

Eligibility criteria

Inclusion criteria

  • Patient over 18 years of age
  • Patient who has given his or her consent to participate in the study
  • Patient affiliated to a social security scheme
  • Patient with a respiratory sample taken between 2020 and 2023 for the retrospective cohort and from 2024 for the prospective cohort in which Aspergillus has been isolated
  • Patients living in the Loire Atlantique and Vendée regions

Exclusion criteria

  • Patient under guardianship or legal protection
  • Patient of no fixed adress

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-control

Study locations

France · 1 center
  • CHU de Nantes — Nantes

Identifiers

NCT: NCT06532227 · RC23_0008

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗