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

Not yet recruiting

• Conditions: Aspergillus Fumigatus Infection
• Interventions: Other: No intervention

• Registration Number: NCT06532227
• Lead Sponsor: Nantes University Hospital

Brief Summary

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

Not available

Study Timeline

• Status Verified: 2024-07
• Study First Submitted: 2024-07-29
• Study First Submitted QC: 2024-07-29
• Study First Posted: 2024-08-01
• Last Update Submitted: 2024-08-01
• Last Update Posted: 2024-08-05
• Study Start: 2024-09-01
• Primary Completion: 2026-09-01
• Study Completion: 2028-08-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 1000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group control : patient without resistance	No intervention	control patients with susceptible Aspergillus.
Group resistant : patient without resistance	No intervention	Cases are patients with resistant Aspergillus

Primary Outcome Measures

Name	Time	Method
Environmental risk factors	24 months	Identify the "macro" environmental risk factors for acquiring azole-resistant aspergillus.

Secondary Outcome Measures

Name	Time	Method
Risk factors	48 months	Identify individual risk factors linked to the immediate environment in the patient's home, drug management, between cases and matched controls, etc..
Describe the management and evolution of resistant	48 months	Clinical information from each additional patient visit and presence or absence of resistant Aspergillus in home samples.