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NCT Number: NCT06532227

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

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.

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Key information

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

No intervention

Other

No intervention excepted data collection

Primary outcomes

  1. Environmental risk factors

    Time frame: 24 months

    Identify the "macro" environmental risk factors for acquiring azole-resistant aspergillus.

Secondary outcomes

  1. Describe the management and evolution of resistant

    Time frame: 48 months

    Clinical information from each additional patient visit and presence or absence of resistant Aspergillus in home samples.

  2. Risk factors

    Time frame: 48 months

    Identify individual risk factors linked to the immediate environment in the patient's home, drug management, between cases and matched controls, etc..

Study contacts

Contact information is provided by the study sponsor or research team.

François-Xavier Blanc, PUPH

CONTACT

[email protected]

0240165710

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Registry information

Acronym: AspergillusOH

Important dates

Study start
2026
Primary completion
2027
Study completion
2029
First posted
Aug 1, 2024
Registry last updated
Jun 24, 2026

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.