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

NCT ID: NCT06532227

Last Updated: 2025-05-23

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

NOT_YET_RECRUITING

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-09-01

Study Completion Date

2028-08-01

Brief Summary

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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.

Detailed Description

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Conditions

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Aspergillus Fumigatus Infection

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

OTHER

Study Groups

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Group control : patient without resistance

control patients with susceptible Aspergillus.

No intervention

Intervention Type OTHER

No intervention excepted data collection

Group resistant : patient without resistance

Cases are patients with resistant Aspergillus

No intervention

Intervention Type OTHER

No intervention excepted data collection

Interventions

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No intervention

No intervention excepted data collection

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nantes University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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François-Xavier Blanc, PUPH

Role: CONTACT

0240165710

Other Identifiers

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RC23_0008

Identifier Type: -

Identifier Source: org_study_id

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